Amgen

  • San Diego, CA, USA

Searching for the Answers Within

At Amgen, we believe in a “biology first” approach. We use cutting-edge science and technology to study the subtlest biological mechanisms in search of therapies that will improve the lives of those who suffer from serious diseases. Amgen believes the cure for disease can be found inside each and every one of us.

 
 

In This Section

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    The Amgen Difference

    We are united and steadfastly focused on a single mission—helping patients.

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    Quick Facts

    Founded in 1980, Amgen has grown to be one of the world's leading independent biotechnology companies.

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    Mission and Values

    Amgen strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.

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    Leadership

    As one of the early pioneers of the biotech industry, Amgen's innovative and inspirational leadership is a core part of our social architecture.

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    How We Operate

    At Amgen, we are relentless in applying the highest ethical standards to everything we do.

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    Awards and Accolades

    Amgen has been the recipient of numerous awards and accolades over the years, ranging from recognition of our pioneering science and innovation, philanthropy and corporate social responsibility to our commitment to being a great place to work.

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    History

    For more than 35 years, Amgen has been unlocking the potential of biology for patients.

Amgen Thousand Oaks, CA, USA
Aug 20, 2019
Full time
Category:  Maintenance Job ID:  R-74232 Location:  Thousand Oaks, CA, US 91360 Posted Date: 4/9/2019 Amgen Thousand Oaks is seeking a Senior Instrument Technician to report to the Maintenance Manager.  The Senior Instrumentation Technician is responsible for performing calibration, repair, installation, troubleshooting and documentation of instruments used on process control systems and building systems in production plants, utility plants and facilities suited and designed for material manufacturing. All work must be completed in a safe and timely manner in accordance to Hazard Risk Assessments (HRA) and Job Hazard Assessments (JHA).All work will be performed according to planning and predefined schedules with minimal impact to production while complying with Good Manufacturing Practices (GMPs), standard operating procedures (SOP) and Amgen policies and regulations.   Position Responsibilities: Perform calibrations of metrology related equipment Perform instrument calibrations for process, utility and analytical equipment and systems Troubleshoot and repair site instrumentation and control system issues Ensure work is completed in a safe and compliant manner in accordance with applicable procedures Ensure that calibration and repair activities are documented in an accurate and compliant manner Execute according to planning and predefined schedules with minimal impact to production while complying with GMP, SOP, CFR and Amgen regulations Knowledge of pneumatic, mechanical, and electronic instrumentation fundamentals, including process control loops, loop checks, loop tuning and troubleshooting computer based control systems (PLC, BMS, DCS, and various HMI) Review and provide feedback on calibration and maintenance reports, forms, and records Revise and review calibration, maintenance or other related procedures Provide regulatory and partner audit support Interpret electrical schematics, I/O wiring and panel drawings, utility, process system/equipment, plumbing, ductwork, and HVAC P&ID's Interact with peers and clients in manufacturing, maintenance, utility plants, analytical labs and contracted services Perform general labor duties and may work in a variety of locations Participate in on-call rotations for after-hours facility and manufacturing support and work outside of established shift hours upon short notice   Basic Qualifications: Associate’s degree and 4 years of instrumentation/calibration experience OR High school diploma / GED and 6 years of instrumentation/calibration experience   Preferred Qualifications: Associate’s degree in metrology, instrumentation, electronics, or related technical discipline Experience performing maintenance and troubleshooting on electrical systems up to 480V 2 years in an FDA (GMP) or similar regulated environment Experience executing and documenting instrumentation work orders in Maximo or similar computerized maintenance management system Strong leadership, technical writing and communication/presentation skills Advanced understanding of process control loops, loop checks, and loop tuning of process control systems Experience with Rosemount instrumentation, Foundation Fieldbus communications and Delta V process control system A high mathematical understanding, excellent reading skills along with intermediate computer and typing skills   Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.   Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.       James
Amgen Thousand Oaks, CA, USA
Aug 20, 2019
Full time
Category:  Quality Job ID:  R-81609 Location:  Thousand Oaks, CA, US 91360 Additional Location:   Posted Date:  8/15/2019 Job Summary   The Associate, Quality Control will support the QC Microbiology lab by performing Environmental, Gowning and Utility Monitoring within the manufacturing areas at Amgen, Thousand Oaks.   Candidates interested in this position must be willing to work a Monday-Friday, 5am-2pm shift with occasional weekend and holiday work.   Key Responsibilities Include: • Collecting surface, air, gas and gowning samples using aseptic technique and in accordance with Amgen Analytical Methods and Standard Operating Procedures • Aseptic gowning • Operating and maintaining specialized equipment • Data entry and approval using Laboratory Information Management Systems • Quality systems support, which may include Deviation ownership and controlled document revisions • Implementation of laboratory/process improvements to ensure a productive and efficient work environment   Basic Qualifications Bachelor’s degree OR Associate’s degree and 4 years of Quality Control or Manufacturing experience OR High school diploma / GED and 6 years of Quality Control or Manufacturing experience    Preferred Qualifications • Experience and training in aseptic technique/aseptic gowning • Basic knowledge of the principles of Microbiology • Laboratory Information Management Systems experience • Technical and investigation writing skills • Demonstrated problem-solving capabilities, leadership skills and ability to independently implement process improvements       James
Amgen Thousand Oaks, CA, USA
Aug 20, 2019
Full time
Category:  Manufacturing Job ID:  R-81973 Location:  Thousand Oaks, CA, US 91360 Additional Location:   Posted Date:  8/16/2019 The Associate of Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and launch activities. Under general supervision, employee will perform operations in the Manufacturing area, specifically B23 Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). This Associate is responsible for hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures.   Responsibilities Perform and monitor critical processes Execute routine validation protocols Comply with GMP's Regularly draft and revise “routine” documents (e.g. MPs, SOP’s, and technical reports) Initiate Quality incidents Identify and recommend improvements related to routine functions and implement after approval Basic troubleshooting Recognize and accurately report problems Direct operators on critical processes Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records) May train staff to perform hands-on tasks May act as safety representative May participate on cross-functional teams and represent the   Basic Qualifications: Bachelor’s degree OR Associate’s degree and 4 years of Manufacturing /Operations experience OR High school diploma / GED and 6 years of Manufacturing /Operations experience   Preferred Qualifications: Bachelor’s Degree in Biology and/or Life Sciences Able to work in teams to complete operational tasks Ability to take direction well, follow documents and policies at all times Ability to take initiative Create a positive work environment through interactions with team members Mechanically inclined Able to lift up to 50lbs and work on your feet for long durations       James
Amgen Thousand Oaks, CA, USA
Aug 20, 2019
Full time
Category:  Manufacturing Job ID:  R-81967 Location:  Thousand Oaks, CA, US 91360 Additional Location:   Posted Date:  8/16/2019 The successful candidate will direct a team of manufacturing associates responsible for manufacture of GMP DSI/DS in both stainless and single-use equipment. The manager will foster a safe and compliant production environment through structured on-the-floor presence. The incumbent will also be an active participant and role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor. The successful candidate must demonstrate strong leadership skills and technical understanding of production operations. Responsibilities include: Staff selection, training, oversight, performance evaluations, and development Daily schedule alignment Partner with QA and other groups to ensure deviations are initiated and closed within target timelines Utilize appropriate systems to perform job duties (SAP/MES, QMTS, LIMS etc.). Interact with business partners and internal/external audit teams and regulatory authorities. Identify and implement process and safety improvements. Work with business partners to support scheduling of maintenance tasks, engineering support, and quality investigations. Effectively elevate critical and impactful events to senior management. Make real-time processing decisions to support compliant and safe production. Ensure batch record review is completed accurately to support disposition timelines Flexible work schedule, including night/graveyard shift and weekend/holiday work as decided by business needs.   Basic Qualifications Doctorate degree Or Master’s degree and 2 years of manufacturing or operations experience Or Bachelor’s degree and 4 years of manufacturing or operations experience Or Associate’s degree and 10 years of manufacturing or operations experience Or High school diploma / GED and 12 years manufacturing or operations experience   Preferred Qualifications 5+ years of related manufacturing experience. 3+ years of experience as a production area Lead, Specialist or Manager Strong technical understanding of Cell Culture and Purification processes and equipment Demonstrated presentation and leadership skills Proven experience with continuous improvement methodologies Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Strong quality system and GMP knowledge Strong troubleshooting skills with laboratory and process equipment Energetic and technically-minded, with strong interpersonal and organizational skills Demonstrated ability to learn new systems and applications, and various new technologies Degree in Life Science, Chemistry or Engineering       James