Process Development Scientist – Cell Sciences and Engineering

Amgen SA; Juncos (PR); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Life & disability insurance

Discretionary bonus

Stock-based incentives

Paid time off

Flexible work models

Job summary

Amgen is seeking a Process Development Scientist to support Drug Substance Cell Sciences and Engineering. You will contribute to process development, technology transfer, and investigations that ensure reliable manufacturing of life-changing therapies.

The role emphasizes data-driven problem solving, cross-functional teamwork, and adherence to cGMP standards while advancing medicines for patients globally.

Qualifications

• Doctorate or Master’s with relevant experience in process development or manufacturing support.
• Experience in biopharmaceutical process development and technology transfer is preferred.
• Familiarity with cGMP and regulated manufacturing environments.

Responsibilities

• Support process improvement initiatives, technology transfers, and data-driven solutions for Drug Substance manufacturing.
• Assist with deviations investigations, root cause analysis, and corrective action implementation.
• Develop and troubleshoot scientific methods and protocols for project needs.
• Prepare technical documents, reports, and regulatory-support materials.
• Collaborate with Manufacturing, Quality, Engineering, and Process Development teams.
• Present data analyses and recommendations to cross-functional teams.

Skills

Data analysis

Statistical analysis

Technical writing

Cross-functional collaboration

Problem solving

Bilingual English/Spanish

Education

Doctorate degree

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Tools

JMP

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. 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 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 Scientist – Cell Sciences and Engineering

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 for Drug Substance manufacturing processes.
• Assist with deviations investigations, root cause analysis, and corrective and preventive action implementation.
• Develop, optimize, and troubleshoot scientific methods and protocols to support project and business needs.
• Author and contribute to technical documents, protocols, reports, presentations, and regulatory-support documentation.
• Maintain awareness of relevant scientific literature, technology developments, and internal best practices, and communicate observations to project teams.
• Collaborate cross-functionally with Manufacturing, Quality, Engineering, Process Development, and other internal partners to support project execution.
• Present data analysis, technical conclusions, and recommendations to internal teams.
• Ensure all work is performed in compliance with applicable safety, quality, regulatory, and cGMP expectations.
• Support department initiatives such as safety programs, continuous improvement activities, recruiting, training, and knowledge-sharing forums, as appropriate.

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:

Doctorate degree

OR

Master’s degree and 2 years of scientific, process development, laboratory, or manufacturing support experience

OR

Bachelor’s degree and 4 years of scientific, process development, laboratory, or manufacturing support experience

Preferred Qualifications:

• Educational background in Life Sciences, Biotechnology, Chemical Engineering, Biochemical Engineering, Biology, Chemistry, or a related engineering or scientific discipline.
• Experience in biopharmaceutical process development, drug Substance manufacturing support, cell culture, process characterization, technology transfer, or process improvement.
• Technical knowledge of mammalian cell culture or bacterial fermentation processes, including seed train, bioreactor, harvest operations, and associated process controls.
• Understanding of regulated manufacturing environments, cGMPs, quality systems, and regulatory expectations.
• Experience supporting deviation investigations, troubleshooting, root cause analysis, product Impact Assessments, contamination assessments, and corrective action implementation.
• Strong technical skills, including scientific analysis, data interpretation, statistical analysis (i.e., JMP software), and problem solving.
• Ability to evaluate process performance and apply data-driven approaches to process monitoring, technical decision-making, and continuous improvement.
• Strong organizational skills, with the ability to manage priorities, document work clearly, and meet project timelines.
• Effective communication skills, including technical writing and presentation of scientific information to cross-functional teams.
• Bilingual communication skills in English and Spanish, written and verbal.
• Ability to collaborate effectively across functions and adapt to changing business needs.
• Flexibility to support non-standard shifts, on-call activities, or manufacturing operations, as required by business needs.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• 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
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

careers.amgen.com

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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 diverse, 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 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. Please contact us to request accommodation.