Amgen
Engineer, Drug Product Process Engineering
Amgen, Thousand Oaks, California, United States, 91362
Engineer, Drug Product Process Engineering
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team.
What You Will Do Let’s do this! Let’s change the world!
The Engineer will join the Drug Product Process Engineering team that is part of Commercial Drug Product Technologies and will be a key contributor to drug product process development, commercialization, and lifecycle management of Amgen’s parenteral product portfolio. The Engineer will integrate the knowledge and information generated by cross‑functional teams with Amgen’s platforms and clinical and/or commercial manufacturing capabilities to ensure success through the commercialization lifecycle. This position is based in Thousand Oaks, CA at Amgen headquarters and is primarily a first‑shift role but may require some time on call during second or third shifts.
Work with a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while developing and applying experience in aseptic processing, equipment, automation, and unit operation characterization.
Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering.
Support technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalities.
Conduct make‑a‑batch exercises to determine facility fit and identify gaps.
Design and execute offline and on‑site drug product characterization studies.
Evaluate product impact from manufacturing process, production scale, equipment, and raw material changes.
Author and/or own high‑quality process technology transfer and other technical documents.
This role provides development opportunities in the following areas:
Dynamic, matrixed organization and collaboration—interfacing with a broad array of partners.
Operational efficiency and business skills application—applying core technical skills to Amgen’s process development operations.
Process development—providing technical input and support to the drug product tech transfer process, including filling recipe development, lyophilization process scale‑up, etc.
What We Expect Of You We are looking for a dynamic professional with the following qualifications.
Basic Qualifications
High school diploma / GED and 8 years of Operations or Process Development experience OR
Associate’s degree and 6 years of Operations or Process Development experience OR
Bachelor’s degree and 2 years of Operations or Process Development experience OR
Master’s degree
Preferred Qualifications
M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline.
Experience working with cross‑functional groups to achieve results.
Highly proficient in presentation skills and drafting technical documents.
Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization.
Fill/finish process scale‑up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools.
Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization.
Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, and associated GMP/Device documentation and regulatory filings.
Ability to learn and act on dynamic information at a rapid pace.
Technology transfer experience across different development phases, fill‑finish process scale‑up, and using gap analysis, root cause analysis, and risk assessment tools.
Strong experience in a matrix team environment, interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality.
What You Can Expect Of Us We support your professional and personal growth and well‑being. Our annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary varies based on experience and qualifications.
All employees receive:
Health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals.
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, and for field sales representatives, a sales‑based incentive plan.
Stock‑based long‑term incentives.
Award‑winning time‑off plans.
Flexible work models, including remote and hybrid work arrangements where possible.
Apply now and make a lasting impact with the Amgen team. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
#J-18808-Ljbffr
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team.
What You Will Do Let’s do this! Let’s change the world!
The Engineer will join the Drug Product Process Engineering team that is part of Commercial Drug Product Technologies and will be a key contributor to drug product process development, commercialization, and lifecycle management of Amgen’s parenteral product portfolio. The Engineer will integrate the knowledge and information generated by cross‑functional teams with Amgen’s platforms and clinical and/or commercial manufacturing capabilities to ensure success through the commercialization lifecycle. This position is based in Thousand Oaks, CA at Amgen headquarters and is primarily a first‑shift role but may require some time on call during second or third shifts.
Work with a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while developing and applying experience in aseptic processing, equipment, automation, and unit operation characterization.
Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering.
Support technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalities.
Conduct make‑a‑batch exercises to determine facility fit and identify gaps.
Design and execute offline and on‑site drug product characterization studies.
Evaluate product impact from manufacturing process, production scale, equipment, and raw material changes.
Author and/or own high‑quality process technology transfer and other technical documents.
This role provides development opportunities in the following areas:
Dynamic, matrixed organization and collaboration—interfacing with a broad array of partners.
Operational efficiency and business skills application—applying core technical skills to Amgen’s process development operations.
Process development—providing technical input and support to the drug product tech transfer process, including filling recipe development, lyophilization process scale‑up, etc.
What We Expect Of You We are looking for a dynamic professional with the following qualifications.
Basic Qualifications
High school diploma / GED and 8 years of Operations or Process Development experience OR
Associate’s degree and 6 years of Operations or Process Development experience OR
Bachelor’s degree and 2 years of Operations or Process Development experience OR
Master’s degree
Preferred Qualifications
M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline.
Experience working with cross‑functional groups to achieve results.
Highly proficient in presentation skills and drafting technical documents.
Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization.
Fill/finish process scale‑up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools.
Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization.
Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, and associated GMP/Device documentation and regulatory filings.
Ability to learn and act on dynamic information at a rapid pace.
Technology transfer experience across different development phases, fill‑finish process scale‑up, and using gap analysis, root cause analysis, and risk assessment tools.
Strong experience in a matrix team environment, interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality.
What You Can Expect Of Us We support your professional and personal growth and well‑being. Our annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary varies based on experience and qualifications.
All employees receive:
Health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals.
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, and for field sales representatives, a sales‑based incentive plan.
Stock‑based long‑term incentives.
Award‑winning time‑off plans.
Flexible work models, including remote and hybrid work arrangements where possible.
Apply now and make a lasting impact with the Amgen team. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
#J-18808-Ljbffr