Process Development Scientist - Commercial Support

Amgen Inc. (IR); Juncos (PR); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen Inc. in United States is seeking a Process Development Scientist – Commercial Support to help monitor and improve parenteral manufacturing processes. You will support technology transfers, investigations, and data-driven initiatives that ensure reliable production of life-changing therapies.

The role requires strong science background, cross-functional collaboration, and experience with regulatory documentation and cGMP expectations. A bilingual English/Spanish capability is valued.

Qualifications

• PhD or MS with relevant process development experience.
• Experience in biopharmaceutical manufacturing and formulation a plus.
• Regulatory and cGMP understanding preferred.
• Strong analytical and communication skills.

Responsibilities

• Support process monitoring and improvement initiatives for Formulation and aseptic Drug Product.
• Assist deviations investigations, RCA, and CAPA implementations.
• Prepare technical documents, protocols, reports and regulatory-support materials.
• Collaborate with Manufacturing, Quality and Engineering teams on projects.
• Perform data analysis and provide technical conclusions to teams.
• Ensure compliance with safety, quality, and regulatory requirements.

Skills

JMP software

Data analysis

Root cause analysis

Cross-functional collaboration

Scientific writing

Presentation skills

Technical writing

Problem solving

Team collaboration

English/Spanish bilingual

Education

PhD in Life Sciences/related field

MS in Life Sciences with 2+ years experience

BS in Science with 4+ years experience

Tools

JMP

Job description

Career Category Process Development 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 – Commercial Support

What you will do

Let’s do this. Let’s change the world! In this vital role, you will join the team to provide support to Amgen’s parenteral manufacturing plant. You will contribute to process monitoring , 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 monitoring, improvement initiatives, technology transfers, and implementation of data-driven solutions for Formulation, and aseptic Drug Product manufacturing processes.
• Assist with deviations investigations, root cause analysis, product impact assessment and corrective and preventive action implementation.
• 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 commercial manufacturing.
• Perform data analysis, and provide 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, , 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.
• Understanding of protein science, formulation and filling processes.
• Relevant experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
• Excellent communication, presentation, problem-solving, project management skills and cross-functional collaboration skills.
• Understanding of regulated manufacturing environments, cGMPs, quality systems, and regulatory expectations.
• Experience supporting deviation investigations, troubleshooting, root cause analysis, product Impact Assessments, , and corrective action implementation.
• Strong technical skills, including scientific analysis, data interpretation, statistical analysis (e.g., JMP software), and problem solving.
• Ability to evaluate process performance and apply data-driven approaches to process monitoring, data trending, 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.
• Experience preparing documentation for regulatory audits and submissions.
• Bilingual communication skills in English and Spanish, written and verbal.
• Ability to collaborate effectively across functions and adapt to changing business needs.
• Flexibility to provide manufacturing floor support in a fast-paces 24/7 operation, including non-standard shifts, on-call activities, or manufacturing operations, as required by business needs.

What you can expect of us

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.

Sponsorship

Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information

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.

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