45 Biotech jobs

The Associate Hazardous Materials Specialist, under direction independently performs the more responsible, varied, and complex work associated with the evaluation, management, and regulation of hazardous materials; performs complex scientific evaluations of facility permit applications, environmental data, chemical contamination data, remedial action plans, compliance with permit conditions, and other regulatory requirements; may also be assigned responsibility for modification or application of complex scientific models in evaluating portions of the work described above. May also be assigned responsibility for development of the more difficult regulations, policies, and lead responsibility over other first working and journey level Hazardous Materials Specialist.   Bruce Riley

Night Production Technician Job Posting Title: Night Production Technician Employment type: Full-time Schedule: Night Shift: 6:00 p.m. – 6:00 a.m. •Four, 12-hour days Monday, Tuesday, Friday, and Saturday for one week. •Three, 12-hour days: Sunday, Wednesday, and Thursday for the following week •Schedule continuously follows this pattern. Reports to: Production Supervisor Job Description: The Production Technician is responsible for the production of the company’s PHA-based thermoplastic material. The Production Technician is responsible for setting up production equipment, cleaning production equipment, and ensuring that the material produced meets the company’s established quality standards. The position follows standard work methods and practices safe work habits to ensure the production process is as efficient and safe as possible. Essential Duties & Responsibilities: •Set up and maintain production machinery.•Measure ingredients to be used in the production process.•Load materials into production equipment.•Clean production equipment and maintain a clean and safe work area.•Maintain a high degree of attention to equipment used and to product(s) produced.•Notify the Shift Lead of any mechanical or material issues.•Record production data.•Maintain accurate production records, machine logs, and test data forms.•Follow verbal and written instructions.•Understand the difference between acceptable and unacceptable product(s).•Package products and equipment for storage or shipment.•Perform work as assigned by the Production Shift Lead. SMTWTHFSWeek 1XXXXWeek 2XXXWeek 3XXXXWeek 4XXX Desired Skills and Experience: Minimum Qualifications: • 3+ years of work experience in a manufacturing environment. • Good oral and written communication skills. • Must be able to learn to operate machinery systems safely. • Must be able to meet schedule requirements. Preferred Qualifications: • Forklift certified. Travel Requirements: None. Benefits: • Competitive pay. • Upward mobility. • Comprehensive medical, dental, and vision insurance. • Gym membership reimbursement plan. • Company supplied fresh fruit, snacks, and drinks. • 401(k) investment plan. • Employee Assistance Plan.   Bruce Riley

What You’ll Get to Do: Assist government design teams with integrating aviation systems into existing and future ship designs on aviation capable ships. Design aviation maintenance facilities to support existing and developmental aircraft on existing and new construction programs. Provide engineering services support to including Spec writing, design, outfitting design, marine drawing and work item development, selected record drawing (SRD) updates, ship checks and other technical work document preparation in accordance with drawing standards and good marine design practice. Generate CAD drawings for use in aviation systems and outfitting. Draft detailed multi-view drawings of aviation facilities and systems. Learn Drafting Standards and apply knowledge and re-use. Review 3D CAD files to ensure shipbuilder compliance with specifications and standards. Assist government design teams with integrating aviation systems into existing and future ship designs on aviation capable ships. Participate in ship trials during the pre-delivery and post-delivery process. You’ll Bring These Qualifications: BS Engineering or 8-10 years of military aviation related experience Experience as a helicopter crewman or maintenance technician on US Navy ships. Ability to write clear reports and specifications in English. Ability to write white and point papers with minimal oversight. Ability to interface with team members, technical leads and Project Managers. Ability to work alone on individual projects with minimal supervision and with other Engineering Disciplines on a team. Proficient with MS Excel, Word, and PowerPoint. Good verbal (English) communication skills. Willingness to travel ≤10% of the time. Must be a US Citizen             Vestnys, Stephanie

Supervisor, Drug Product Manufacturing - Formulations Location San Diego, CA Department Drug Product Manufacturing - Formulation - 420 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   We are looking for a Supervisor, Drug Product Manufacturing - Formulations . The Supervisor, Drug Product Manufacturing role in Formulations offers the opportunity to work with a dynamic team on exclusive and varieties of drug product manufacturing processes using current and innovative technologies. As part of this team, the position will provide expert technical support to both internal and external teams through new product tech transfers, drug product process design, engineering runs and commercial formulations.   The Supervisor manages a group responsible for drug product manufacturing formulations from the floor. This position will work closely with internal cross-functional departments as necessary to plan, schedule, and execute all aspects of production operations related to manufacturing formulations in a validated cGMP environment.   Responsibilities: Overseeing daily scheduled operations and troubleshoots process related issues. Plan, design, execute, and document new studies or protocols related to drug product formulation development, mixing, filtration, and process development Author, review and execute department related batch records and SOPs. Responsible for department change controls, deviations, CAPA’s (Corrective Actions, Preventative Action) initiation and participation as needed on investigations to support closure. Client calls, interactions and meetings (calls, kick off meeting, tours, and operational issues) Facility planning (Shutdowns, maintenance, APV planning) Audit Responses (Client, QP, and Regulatory Inspections, SOP and Batch record revisions) Assist with the coordination and implementation of process and equipment validation protocols (installation, operational, performance qualification). Support with identifying process improvement opportunities and lead initiatives to increase efficiency of work execution, data analysis and visualization. Effectively and consistently communicate with management, cross-functional partners and parities on progress towards manufacturing deliverables, special projects, tasks, milestones, risks and strategies. Identifies, escalates, and documents events and subtle variances that deviate from normal operation. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements: Bachelor's degree in a life sciences or equivalent experience required. Minimum five (5) years relevant technical experience. Minimum two (2) years leadership experience. Full leadership responsibilities. Understanding of cGMP's. Understanding of regulatory requirements. Solid command of chemistry. Understanding of drug product formulation equipment, technical aspects of the processes and formulations. Understanding of QAD, Master Control, LIMS, and RAM.   Leadership Responsibilities: Directs and provides expert knowledge in the day-to-day operations of Drug Product Manufacturing- Formulations. Identifies, recruits, and retains top-notch talent. Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals. Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities. Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management. Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication. Provides oversight and direction to the employees in accordance with Aji Bio-Pharma’s policies and procedures.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Supervisor, Drug Product Inspection Location San Diego, CA Department Inspection - 430 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   We are looking for two Supervisors, Drug Product Inspection to join our team on first and second shift! The Supervisor, Drug Product Inspection manages direct reports responsible for all aspects related to visual inspection operations. This position is responsible for implementation of all procedures as they relate to inspection operations to comply with regulatory requirements and also to coordinate the planning, scheduling, and execution of operations with other departments.   Please note: hours will very dependent on the schedule, however, 1st shift typically will be 8:00-5:00pm and 2nd shift will be 3:00-11:30 pm.   Responsibilities: Supervises department Group Leads and responsible for all employee coaching, development and engagement. Oversees employee training program. Oversees and schedules production operations and employees within cGMP guidelines. Manages and facilitates interactions and communications with internal stakeholders regarding production. Interacts with client auditors as a visual inspection and cGMP subject matter expert. Manages cGMP visual inspection activities including document production and review, internal continuous improvement projects, and assurance of cGMP compliance within Drug Product Inspection. Provides technical support to manufacturing and investigations staff within areas of specialty. Employs high level technical expertise to develop new processes and creatively solve problems. Oversees, reviews and approves inspection protocols, SOPs, forms, and study reports. Oversees research and implementation of new methods and technologies to enhance operations. Suggests improvements to existing methods and procedures. Oversees automated counting systems. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements: Bachelor's Degree strongly preferred in a Life Sciences discipline or equivalent training and experience required. Minimum of five (5) years of relevant experience in a manufacturing or laboratory environment preferred. Minimum of one (1) year of strong leadership/supervisory experience required. Experience with cGMP, manufacturing, machine operations, and data entry preferred. Detail oriented with strong verbal and written communication skills. Demonstrated ability to follow detailed directions in a manufacturing GMP environment. Ability to work independently, within prescribed guidelines, or as a team member. Proficiency with Microsoft Office applications.   Leadership responsibilities: Directs and provides expert knowledge in the day-to-day function of Drug Product Inspection. Identifies, recruits, and retains top-notch talent. Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals. Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities. Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management. Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication. Provides oversight and direction to the employees in accordance with Aji Bio-Pharma’s policies and procedures.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities           Jason Bailey

Sr. Sterilization Associate II Location San Diego, CA Department Fill Finish Mfg - 410 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.      Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   We are looking for a Sr. Sterilization Associate II to join the team! In this role you will perform and direct a wide variety of product sterilization and biological indictor testing tasks. You will complete training of the use of the terminal sterilizer, utilities and laboratory techniques and will be responsible for the handling of products in addition to writing and execution of standard operating procedures (SOP’s), protocols and batch records while working under cGMP regulations. You will work under little supervising and independently.   Responsibilities: Follow all safety and gowning procedures at all times. Writing and approval of SOPs, protocols, reports and batch records. Responsible for cycle development and design specific to individual product and sterility needs. Designs client / product specific feasibility studies. Leads running of sterilization cycles per established SOP or protocol. Oversees programming of sterilization cycles. Use of validation (validator) and calibration equipment. Performs and directs laboratory work for feasibility, D-value and Z-value studies. Trains junior staff. Orders, specs out, tests and approves incoming testing and continued maintenance of biological indicators. Coordinates with facilities, validation and engineering with respect to preventive maintenance and work orders. Primary contact for clients and vendors. Logbook review and completion of applicable batch records. Review SOP / BR revisions and defend CC documents Embodies Aji Bio Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements: Minimum Bachelor’s degree in life sciences or equivalent. Minimum six (6) years relevant experience in a laboratory or manufacturing environment. Detail oriented with strong written and verbal communication skills. Subject matter expert understanding of sterilization sciences / regulations and steam/air utilities. Mechanical aptitude is required. Good understanding of manual inspection techniques and DP manufacturing processes. Ability to work independently, within prescribed guidelines, and as a team member.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Sr. QC Chemistry Assistant Location San Diego, CA Department QC Chemistry - 630 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   We are looking for a Sr. Research Assistant - Chemistry to support Ajinomoto Bio-Pharma Services manufacturing. The Sr. Research Assistant - Chemistry is responsible for conducting moderate to complex routine analysis of raw materials, proteins, peptides and small molecules under general supervision. May focus in a specialized area and provide routine analysis and testing according to standard operating procedures in any of the following areas: in process and finished formulations. Responsibilities: Perform routine analysis and testing Documentation review and report writing Assist in transfer, qualification and validation of new methods Training Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. Embodies Aji Bio-Pharma's cultural values and aligns daily actions with department goals and company culture Requirements: Minimum of 2 years of relevant experience required High School Diploma or Bachelor's degree in a Life Science discipline. Minimum of two (2) plus years of experience with cGMP preferred Ability to perform testing in a highly accurate and reproducible manner Adhere to GMP guidelines and SOPs Possessed good Analytical skills and understanding of Quality systems and regulations Strong communication and teamwork Needs regular supervision to deliver goals and objectives   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Sr. QA Batch Release Associate Location San Diego, CA Department Quality/Regulatory - 750 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   We are currently seeking a Sr. QA Batch Release Associate I to support Ajinomoto Bio-Pharma Services’ manufacturing. The Sr. QA Batch Release Associate I independently reviews and approves lot file documentation. This position writes and performs investigations in support of product quality, collaborating with process owners to perform review and approval of quality documentation. This includes investigating, troubleshooting, and rectifying issues as a result of QA analysis.   Responsibilities : Reviews and approves executed and non-executed lot file documentation in support of the manufacture and testing of Drug Substance and Drug Product. Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis. Trains new employees and other technical personnel on activities related to batch release Interacts with clients and follows up on client inquiries Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements : Bachelor’s degree in a Life Sciences discipline or equivalent experience required. Minimum of six (6) years of experience in batch release documentation review, QA, or equivalent Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices Knowledge of Fill Finish and Biologics production environments strongly preferred Detail oriented with strong written and verbal communication skills       Jason Bailey

Sr. Project Manager I Location San Diego, CA Department PMO - 710 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you. We are looking for a Sr. Project Manager I to join the team. The Sr. Project Manager I is an essential player in managing client specific projects, from kick off meetings to product shipment.   This role is responsible for project management tasks for custom Drug Substance (DS), Drug Product (DP), and ADC manufacturing projects that support key clients & internal objectives. This position drives planning and decision-making while developing implementation strategies and leading efforts for projects. This position will lead complex, cross-functional internal and external project team activities and will work with team members to create and maintain project plans and timelines, which may include budget, definition, scope, supply chain management, financial resources allocation, dependencies, and target dates.   Responsibilities : Manages clinical or commercial GMP manufacturing projects governed by a contract between Ajinomoto Bio-Pharma Services and client including but not limited to: tech transfer, Drug Substance (DS) Production, Drug Product (DP) Production, ADC Production. Responsible for development of project timelines and tracking of contract deliverables. Hosts project meetings to provide status update to clients and internal cross-functional team members. Communicates effectively with client and across all functional groups so that schedules and scope of the project is clear. Tracks and forecasts revenue generating activities. Works with finance to ensure invoices are accurate and paid on time. Identifies project issues such as resource, technical or scheduling constraints and assists to resolve these issues internally and with external stakeholders by development of risk assessments, summarized options and proposed solutions with impact statements. Ensures that projects are completed on time, within budget and scope, and conforms to predetermined quality standards. Responsible for hosting client visits. Responsible for evaluating unexpected deviations that may impact project deliverables or timelines and taking steps to resolve these issues. Assists with project closeout and provides summaries/feedback for proposed process change. Provides group training and assists Project Managers as a mentor on technical or project management related processes as needed. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements : Bachelor's degree required. Bachelor's or Master's degree in a life sciences or business discipline preferred. PMP preferred. Minimum of seven (7) years in Biotech/Pharma or CMO. Minimum of four (4) years in Project Management. Strong computer skills, MS Office, MS Word, MS PowerPoint. MS-Project is preferred. Excellent organizational and interpersonal skills. Strong verbal and written communication skills. Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment Demonstrated leadership, interpersonal, matrix management, problem solving, and conflict resolution skills. Must be able to prioritize and multi-task, work effectively with little or no direction, and build collaborative relationships with management, partners and peers from diverse backgrounds. Understanding of biotech or drug product development and of multi-project planning and coordination is required. Regulatory experience preferred.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Sr. Process Science Associate I - Downstream Location San Diego, CA Department Process Development - 530 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   Ajinomoto Bio-Pharma Services is currently seeking a Sr. Process Science Associate I – Downstream to support Ajinomoto Bio-Pharma Services’ manufacturing. The Sr. Process Science Associate I – Downstream is responsible for the development, optimization and scale-up of downstream manufacturing processes for large scale plasmid and protein production. Responsibilities : Designs and conducts experiments with lab notebook/documentation that follow protocols and accurately records procedure and results. Optimizes protein and plasmid recovery from microbial cells and culture media and protein refolding; screens chromatography resins; optimizes overall purification process, chromatography, ultrafiltration (UF) and diafiltration conditions; optimizes overall product quality and yield. Completes analytical testing for process science experiments and manufacturing investigations. Performs data analysis and prepares results summaries. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture. Requirements : Bachelor’s degree in Life Sciences_ discipline or equivalent required. Minimum of eight (8) years of experience. Extensive experience and expert understanding of principles of anion/cation exchange, hydrophobic interaction, multimodal and hydroxyapatite chromatography. AKTA Systems Experience preferred. Expert understanding of principles and extensive experience with tangential flow filtration (TFF), ultrafiltration (UF) and diafiltration (DF). Extensive analytical assay experience (SDS PAGE and agarose gel electrophoresis, protein and DNA concentration determinations, immunoassays). Adept at experimental design and analysis. Protein and/or plasmid manufacturing experience.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Sr. Manager, QA Batch Release Location San Diego, CA Department Quality/Regulatory - 750 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you. We are looking for a Sr. Manager, QA Batch Release to join the team. In this role you will be responsible for the direct oversight of development, implementation, maintenance, and performance of QA systems, programs and continuous improvement efforts.  The Sr. Manager is responsible for ensuring effective systems are maintained for batch disposition, lot file review and documentation review.    As a Sr. Manager you will provide exceptional leadership to the Batch Release team through mentoring and developing team members and providing your technical expertise to ensure compliance with both U.S and international regulatory requirements.   Responsibilities : Manages lot disposition activities related to manufacture and testing of Drug Substance and Drug Products to ensure compliance to internal and regulatory requirements. Ensures that the process for evaluating the impact of deviations and adverse events to product quality are properly executed and assigns product disposition.  Acts as the liaison between Aji Bio-Pharma’s QA department and customer’s QA departments for complex processes.  Provides solutions to complex problems relating to GMP. Assembles, Analyzes and Delivers detailed quality assurance metrics to Sr. Leadership. Develops and oversees effective training processes to ensure adequate training is in place for batch disposition activities. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements : Bachelor’s degree in a Life Sciences discipline or equivalent experience required. Minimum of seven (7) years of experience in regulated biotech, pharmaceutical or medical device industry. Minimum of three (3) years of QA leadership/supervisory experience in a regulated biotech pharmaceutical or medical device industry. Working knowledge of drug development and GMP aseptic processing operations. Knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices. Detail oriented with strong written and verbal communication skills.     Supervisory Responsibilities : Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals. Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities. Identifies, recruits, and retains top-notch talent. Directs and provides expert knowledge in the day-to-day function of QA Regulatory. Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management. Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication. Provides oversight and direction to the employees in accordance with Aji Bio-Pharma’s policies and procedures.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Sr. MQA Assistant Location San Diego, CA Department Quality/Regulatory - 750 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   Ajinomoto Bio-Pharma Services is currently seeking a Sr . MQA Assistant. The Sr. MQA Assistant ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. This position requires the ability to work independently, within prescribed guidelines, and as a team member. The Sr. MQA Assistant promotes a cGMP environment and follows Standard Operating Procedures (SOP’s) and is detail oriented with strong written and verbal communication skills.   Responsibilities : Processes cGMP documentation through initiation, revisions, and deletions. Assists with and performs, as directed, cGMP audits including audit preparation, execution, audit report, and follow up findings. Performs AQL inspection of final filled product. Performs line clearance operations in support of manufacturing processes. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements : High school diploma or equivalent experience required. Bachelor’s degree in Life Sciences discipline or equivalent strongly preferred. Minimum of two (2) years of experience in documentation, QA or equivalent. Knowledge of cGMP regulations and good documentation practices preferred. Demonstrated ability to follow detailed directions in a laboratory environment.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Sr. Manager, Quality Assurance Location San Diego, CA Department Quality/Regulatory - 750 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   We are looking for a Sr. Quality Assurance Manager to lead our quality systems teams. In this position you will support and develop leaders and individual contributors to help the organization continue to grow and maintain a high level of compliance. Responsibilities include leading audits, regulatory inspections, training programs, and documentation review.   Responsibilities: Provides input to senior management on Quality Systems. Identifies and executes continuous Quality System improvement independently or through next level staff, as appropriate through quality management review. Manages staff who perform comprehensive internal and external audits in accordance with written procedures to verify the adequacy and effectiveness of procedures and processes. Establishes and improves the systems and processes required to conduct the audits/inspections. Oversees the management of Technical Quality, Document Control, Investigations and Complaints and CAPA program. Collaborates with internal departments to ensure effective regulatory and customer audit responses/corrective actions are generated in a timely manner. Prepares for regulatory inspections including staffing, scheduling and task prioritization. Hosts with oversight of Sr. management regulatory inspections for US FDA, EMA, PMDA and other worldwide regulatory bodies. Independently investigates, troubleshoots, and rectifies issues resulting from QA analysis. Lead management of site compliance activities related to quality risk management and data integrity. Champion operational excellence (OE) projects for QA Compliance. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture. Requirements: Bachelor’s degree in a Life Sciences discipline or equivalent experience required. Minimum seven (7) years of relevant experience in auditing, documentation, Quality Assurance or equivalent. Minimum of three (3) year of functional leadership experience. Knowledge cGMP regulations and good documentation practices. Detail oriented with strong written and verbal communication skills. Proven ability to lead and manage projects and teams. Experience interacting with clients, regulators and senior staff. Strong organizational and analytical skills. Experience with MasterControl or other electronic Quality Systems, a plus. Leadership Responsibilities: Directs and provides expert knowledge in the day-to-day function of Quality Assurance. Identifies, recruits, and retains top-notch talent. Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals. Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities. Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management. Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication. Provides oversight and direction to the employees in accordance with Aji Bio-Pharma’s policies and procedures.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Sr. Drug Product Packaging Assistant Location San Diego, CA Department Packaging - 450 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   We are looking for a Sr. Drug Product Packing Assistant. In this role you will be responsible for operating manufacturing equipment and implementing established procedures. This position is also responsible for the accurate handling of products following standard operating procedures (SOP’s) and working under cGMP regulations.   Responsibilities: Performs various routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations. Performs final product packaging and completed required qualifications where applicable. Labels and boxes filled goods. Assists other technical personnel on issues and problem resolution Collects and disposes of wastes according to established procedures. Responsible for routine maintenance of labeling and packaging equipment. Maintains cGMP environment. May be asked to draft SOP’s and associated forms. May be asked to oversee product transfers. May be asked to oversee batch sampling, sample submissions, and storage activities. May be asked to assist with training. May be asked to oversee packaging and labeling operations. May be asked to create raw material specifications. Project planner (schedules and coordinates with supply chain, ordering and requesting materials for labeling and packaging campaigns ) Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements: High School Diploma Required. Bachelor’s degree in a Life Sciences discipline or equivalent preferred. Minimum of two to three (2-3) years of relevant experience in manufacturing. Highly detailed oriented. Ability to teach and direct personnel. Familiarity with cGMP, Master Control, LIMS, and QAD. Experience with creating/editing MS Excel spreadsheets   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Senior Cost Accountant Location San Diego, CA Department Finance - 110 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   We are looking for an eagle-eyed Senior Cost Accountant to provide financial decision-making information and guidance to leaders and ensure that the highest standards of accounting and control are maintained. In this role you will work with large amounts of data to prepare trend and variance reports designed to identify performance issues and risk. Additionally, you will support cross-functional continuous improvement initiatives by providing cost modeling and financial analysis.   Responsibilities: Perform inventory and project profitability analyses, identify and concisely communicate issues, and recommend solutions or process improvements. Responsible for management of the Fixed Asset process, policy, and procedures, including figuring out additions/retirements, confirmation of assets and impairment review, and working with third party consulting firm on property tax requests as well as annual insurance renewals. Assist cross-functional leaders in making critical decisions by translating cost data into useful information. Partner with Sales and Clients Services by determining costs for new products and contract proposals; adjust forecast models, where necessary. Monthly accounting tasks, including journal entries, reconciling general ledger accounts to perpetual records, margin analysis, and preparing supporting schedules. Recommend and develop processes to enhance and improve efficiencies within the cost accounting function, by streamlining accounting processes and mapping work flows. Help spearhead ERP system upgrades and transitions. Lead administrator and accountant for the annual physical inventory. Review all work orders to ensure accounting is accurate and any issues are resolved quickly.   Requirements: Bachelor's degree in Finance or Accounting required; CMA, CPA, or MBA is a plus. 6-8 years of accounting experience within a manufacturing environment. Strong technical and financial skills with an ERP system. Must be advanced in Microsoft Excel and proficient in Word, PowerPoint and Outlook. Solid understanding of financial statements and GAAP accounting principles. Hands on and detail oriented, with proven abilities to work with all levels of management. Outstanding interpersonal skills and the ability to work effectively with other departments and auditors. Sense of urgency and self-motivation, with a personal dedication to meeting deadlines.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Safety, Health & Environment Specialist Location San Diego, CA Department SHE - 300 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you. We are looking for a Safety, Health, and Environment Specialist to support Ajinomoto Bio-Pharma Services’ manufacturing. The Safety, Health and Environment Specialist is an experienced SHE professional that coordinates and performs technical and administrative SHE department activities. Depending on the company and departmental needs, this positon may have a specialty focus such as; Industrial Hygiene, Environmental Management, Facilities and Contractor Safety, or function as an SHE Generalist.   Responsibilities : Responsible for determining applicability, developing content, and facilitating SHE training programs. Such as; new hire SHE orientation, annual SHE refresher training , select and specialized SHE training . Maintains SHE documentation systems. Coordinates emergency preparedness activities such as; maintains building evacuation lists, coordinates evacuation drills , participates in the Incident Response Team, provides training . Oversees hazardous waste consolidation and hazardous waste shipping activities. Provides administrative management support for SHE related licenses and permits. Schedules SHE observations and coordinates the completion of corrective action in a timely manner. Calculate and communicates SHE key performance indicators as directed by SHE departmental management. Performs hazard and risk assessment, develops and communicates risk mitigation strategies. Performs incident investigation and determines root cause and corrective or preventive actions. Determines applicability, develops, and implements SHE written policy and procedures . Responsible for maintaining and reviewing SDS of new chemicals and communicating the hazards associated with the chemicals. Coordinate ergonomic activities such as; evaluation of employees work spaces, making recommendations for improving ergonomics, and tracking the progress of the employee’s ergonomic issues. Responsible for working with affected departments to issue safe work permits such as; hot work, lockout /tag out, confined space, live electrical work and other safe work permits. Administration of the Safety Incentive Program . Acts a cultural leader for SHE initiatives such as Zero Injury Mindset and Care for the Environment programs. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements : High School Diploma or equivalent required. Associates Degree or Training Program Certificate in related discipline required. BA or BS in related field strongly preferred.  Professional certification such as; CHMM, CSP, CIH or progression toward certification is highly desirable. Minimum of five (5) years of relevant experience in Environmental Health and Safety. Laboratory or manufacturing experience desired. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Must be familiar with Microsoft Office applications.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

QA Batch Release Associate Location San Diego, CA Department Quality/Regulatory - 750 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you. We are looking for a Quality Assurance Batch Release Associate responsible for performing a wide variety of activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements, including assisting with audits, training programs, and documentation review.   Responsibilities : Reviews production batch records and associated data for product release.  Determines if records are within range of cGMP regulations. Reviews data obtained for compliance specifications and report abnormalities. Evaluates the impact of deviations and adverse events to product quality. Interacts with clients and follows up on client inquiries. Supports most quality functions and potential issues for assigned clients. Conducts cGMP audits including audit preparation, execution of the audit, the audit report, and follow up to any findings. Assists in the writing of detailed reports and analyzes quality data. Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions. Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. Assists in the training of new employees and other technical personnel. Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. Performs logbook documentation audits for cGMP regulated logs and SOPs. Performs Line Clearances for cGMP processes. Creates cGMP labels, and reviews and reconciles cGMP label generation. Embodies Ajinomoto Bio-Pharma Services’ cultural values and aligns daily actions with department goals and company culture.                                   Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.   Requirements : High School Diploma required. Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent. Minimum four (4) years of relevant experience in documentation review, QA or equivalent. Minimum one (1) year of batch review experience. Working knowledge of GLP and cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices. Knowledge of Fill Finish and Biologics production environments strongly preferred. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Demonstrated ability to follow detailed directions in a laboratory environment. Strong organizational and analytical skills. Must be familiar with Microsoft Office applications.       Jason Bailey

Production Planner II Location San Diego, CA Department Procurement - 730 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you. We are looking for a Production Planner II to support Ajinomoto Bio-Pharma Services’ manufacturing. The Production Planner II is responsible for managing the tactical planning activities to meet the manufacturing requirements of Ajinomoto Bio-Pharma Services from clinical trials through to commercial products across all business locations.  The key objectives of this role are to create and maintain bill of materials, item master maintenance, creation and maintenance of work orders, and entering tech transfers and forecasts to support the MRP process. This position works together with other departments cross functionally to support business growth, improve customer service and plan effectively. The position will work closely with other members of the Supply Chain Management group as well as Project Management, Client Services, Manufacturing, Quality Control, Quality Assurance and Finance.     Responsibilities : Review, monitor and reconcile final product work orders to ensure appropriate demand and inventory levels are accurate. Support material requirements planning for multiple manufacturing sites and multiple products. Ensure daily production requirements are achieved to meet the Master Production Schedule. Support the lifecycle management process to optimize inventory levels, reduce material expiry and scrap. Maintain all Planning related ERP system Master Data. Maintain effective communication with operational groups to proactively reduce urgent/rush requests. Maintain commercial forecasts. Analyze and research material shortages, availability and ETA for raw materials.  Ensure materials are available at time of scheduled prep date. Create and update final product and formulation product structures (Bill of Materials). Review, monitor, reconcile and close resupply work orders. Analyze and review expiration report monthly (90 day window). Authoring of deviations related to inventory transfers. Post production inventory review and reconciliation. Analyze, review and reconcile QA Hold and rejected materials.  Monitors systems and procedures and ensures compliance to company authorizations, policies, and procedures with respect to the purchasing and planning function. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements : High School Diploma Required. Bachelor’s degree in a business related discipline or equivalent experience preferred. Membership of professional body such as APICs preferred. Minimum of two (2) years related planning experience including one (1) year in GMP environment. Knowledge of planning (MRP) and ERP experience required. Pharmaceutical, biotech and or CMO experience preferred. The ability to define the needs and wants of stakeholders. The ability to work in an orderly and methodical fashion to solve problems. The ability to build relationships with internal and external stakeholders. The ability to support cross functional teams and Lean Six Sigma and continuous improvement projects. The ability to demonstrate compliance to internal and external codes of conduct, policies and regulations. Experience in supporting the development of planning procedures, and systems. Intermediate knowledge of Microsoft Office products. We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Production Coordinator II Location San Diego, CA Department Fill Finish Mfg - 410 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you. We are looking for a Production Coordinator II . In this role you will be responsible for planning and coordinating cGMP products through the production cycle, ensuring materials are ready and onsite on time for planned production schedules. You will keep in communication with the leaders to provide input and updates about production timelines. Your essential job duties will include collaborating with project managers, clients, supply chain and the quality departments to coordinate production readiness and meet manufacturing timeliness. You will work to resolve potential schedule interruptions or rescheduling by maintaining readiness and working with management and procurement on timeliness and issues.   Responsibilities : Coordinates flow of materials within or between departments to support production demands. Reviews Master Production Records and performs comparison to work orders to ensure accuracy and availability of require materials. Coordinates with internal manufacturing, project management, procurement, internal logistics, quality control and quality assurance to maintain production timelines. Tracks receipt and release of all production materials including raw materials and client supplied materials pertinent to production batches. Authors specifications for consumables, GMP materials, and Client Specified Materials (CSM’s). Authors and tracks deviations associated to release of GMP materials and CSM’s. Tracks limiting materials for each production batch and communicates to management and appropriate personnel. Tracks changes in batch sizes based on client changes as well as changes in incoming Client Specific Material. Works with vendors to help craft new specifications and improve current material issues. Assists in building metrics that identify strengths and weaknesses in the process. Works with production planners and procurement to streamline processes and improve communication. Coordinates some production activities related to Client Specific Materials (CSM’s). Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture. Requirements : High School Diploma or equivalent experience required. Bachelor’s degree in a Life Sciences discipline and/ or Business preferred. Minimum of two to four (2-4) years of experience in procurement, materials management, or manufacturing. Strong organizational skills and comprehensive follow-through. Strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Proficiency with Microsoft applications. Experience with QAD/ERP systems would be a strong asset.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities       Jason Bailey

Process Science Associate II - Downstream Location San Diego, CA Department Process Development - 530 Apply Now Together, Let’s Make A Difference.   At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.   Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.   We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.   Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.   We are currently seeking a Process Science Associate II - Downstream to support Ajinomoto Bio-Pharma Services’ manufacturing. The Process Science Associate II- Downstream, assists in development, optimization and scale-up of downstream manufacturing processes for large scale plasmid and protein production.   Responsibilities : Designs and conducts experiments with lab notebook/documentation that follow protocols and accurately records procedure and results. Optimizes protein and plasmid recovery from microbial cells and culture media and protein refolding; screens chromatography resins; optimizes overall purification process, chromatography, ultrafiltration (UF) and diafiltration conditions; optimizes overall product quality and yield. Completes analytical testing for process science experiments and manufacturing investigations. Prepares components, media, buffers, and other solutions as needed. Performs data analysis and prepares results summaries. Prepares reports and project presentations. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.   Requirements : Bachelor’s degree in a Life Sciences discipline or equivalent required. Minimum of three (3) years of experience in protein and plasmid purification. Experience and understanding of principles of anion/cation exchange, hydrophobic interaction, multimodal and hydroxyapatite chromatography. Understanding of principles and experience with tangential flow filtration (TFF), ultrafiltration (UF) and diafiltration (DF). Basic analytical assay experience (SDS PAGE and agarose gel electrophoresis, protein and DNA concentration determinations, immunoassays) Adept at experimental design and analysis. Protein and/or plasmid manufacturing experience.   We provide a Total Rewards package designed to make life better – both at work and at home. Annual Bonus Opportunities for All Employees 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off Annual Company Shutdown in December Comprehensive Medical, Dental + Vision 401K Company Match + Immediate Vesting Backup Daycare and Eldercare Monthly Employee Appreciation Events and Food Truck Fridays Employee Discount Programs Tuition Reimbursement Casual Dress Code Wellness Programs Community Outreach Opportunities         Jason Bailey