Process Development Associate Scientist - Commercial Support

Amgen

Juncos (PR)

On-site

USD 90,000 - 120,000

Full time

4 days ago
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Benefits offered by this job

Comprehensive benefits
Annual bonus
Stock-based incentives
Flexible work models

Job summary

Amgen Inc. explains its mission to serve patients via a broad pipeline and robust manufacturing capabilities.

The role focuses on supporting Drug Substance manufacturing through process development, improvements, investigations, and technology transfers. You will author technical documents and collaborate with Manufacturing, Quality, Engineering, and Process Development to ensure compliant, efficient operations.

Qualifications

  • Master’s degree with 1 year of experience or Bachelor’s with 3 years of experience in scientific, process development, lab, or manufacturing support.
  • Experience in biopharmaceutical process development, Drug Substance manufacturing support, cell culture, and technology transfer.

Responsibilities

  • Support process improvement initiatives and technology transfers.
  • Investigate deviations and perform root-cause analysis.
  • Develop and optimize scientific methods, processes and protocols.
  • Prepare technical documents, protocols and regulatory support.
  • Collaborate with cross-functional teams to drive project execution.

Skills

Biopharma process development
Data-driven decision making
Cross-functional collaboration
Statistical analysis (JMP)
Documentation & technical writing

Education

Master’s degree in Life Sciences or related
Bachelor’s degree in Life Sciences or related

Tools

JMP

Job description

Career Category Scientific Job Description 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Associate Scientist – Commercial Support
What you will do

Let’s do this. Let’s change the world! In this vital role, you will join the Drug Substance Cell Sciences and Engineering team to provide support to Amgen’s manufacturing plants. You will contribute to process development, process improvement, investigations, technology transfers, and other projects that support reliable manufacturing and delivery of life-changing therapies to patients. Specific responsibilities include but are not limited to:

  • Support process improvement initiatives, technology transfers, and implementation of data-driven solutions to enhance Drug Substance manufacturing processes.
  • Investigate deviations, perform root cause analysis, and support the implementation of corrective and preventive actions (CAPAs).
  • Develop, optimize, and troubleshoot scientific methods, processes, and protocols to meet project and business objectives.
  • Author and review technical documents, protocols, reports, presentations, and regulatory support documentation.
  • Stay current on scientific literature, emerging technologies, and industry best practices, and apply relevant insights to projects and operations.
  • Partner with Manufacturing, Quality, Engineering, Process Development, and other cross-functional teams to drive project execution and operational excellence.
  • Analyze, interpret, and present data-driven findings, technical conclusions, and recommendations to stakeholders.
  • Ensure compliance with safety, quality, regulatory, and cGMP requirements in all activities and deliverables.
  • Contribute to departmental initiatives, including safety, continuous improvement, training, recruiting, and knowledge-sharing activities.
What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Process Development Scientist professional we seek is a collaborative and technically strong individual contributor with these qualifications.

Basic Qualifications
  • Master’s degree and 1 year of scientific, process development, laboratory, or manufacturing support experience OR Bachelor’s degree and 3 years of scientific, process development, laboratory, or manufacturing support experience
Preferred Qualifications
  • Bachelor's degree in Life Sciences, Biotechnology, Chemical Engineering, Biochemical Engineering, Biology, Chemistry, or a related scientific or engineering discipline.
  • Experience in biopharmaceutical process development, Drug Substance manufacturing support, cell culture, process characterization, technology transfer, and/or process improvement.
  • Working knowledge of mammalian cell culture and/or bacterial fermentation processes, including bioreactor operations, harvest processes, and associated process controls.
  • Understanding of cGMP-regulated manufacturing environments, quality systems, and regulatory requirements.
  • Experience supporting deviation investigations, troubleshooting, root cause analysis, product impact assessments, contamination assessments, and CAPA implementation.
  • Strong technical and analytical skills, including scientific data interpretation, statistical analysis (e.g., JMP), process monitoring, and data-driven decision-making.
  • Ability to evaluate process performance, identify improvement opportunities, and implement effective solutions.
  • Strong organizational, project management, and documentation skills, with the ability to manage multiple priorities and meet timelines.
  • Effective written and verbal communication skills, including technical writing and presentation of scientific data to cross‑functional teams.
  • Bilingual proficiency in English and Spanish, both written and verbal.
  • Demonstrated ability to collaborate across functions, adapt to evolving business needs, and thrive in a fast-paced environment.
  • Flexibility to support non-standard schedules, on‑call responsibilities, and manufacturing operations, as required.
What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well‑being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
  • A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
  • Stock‑based long‑term incentives
  • Award‑winning time‑off plans and an annual site shutdown
  • Flexible work models where possible.
Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

. 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 biologics manufacturing 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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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