Process Development Scientist - Commercial Support

amgen; Juncos (PR); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Total Rewards Plan

Competitive Benefits

Flexible work model

Career development

Job summary

Amgen seeks a Process Development Scientist – Commercial Support to join our team in Puerto Rico. You will help monitor and improve parenteral manufacturing processes, contribute to tech transfers, and support investigations and regulatory documentation.

The role requires advanced degrees with strong data analysis, cGMP knowledge, and bilingual English/Spanish communication. You will collaborate across Manufacturing, Quality, Engineering and Process Development, including 24/7 operations support.

Qualifications

• Doctorate or Master’s with 2+ years experience in scientific, process development or manufacturing support.
• Biopharmaceutical manufacturing experience preferred, especially formulation and aseptic filling.
• Strong communication, project management and cross-functional collaboration skills.
• Knowledge of regulated manufacturing, cGMPs, quality systems and regulatory expectations.
• Bilingual English/Spanish written and verbal communication.

Responsibilities

• Support process monitoring, improvement initiatives and technology transfers for formulation and aseptic drug product manufacturing.
• Assist deviations investigations, root cause analysis, product impact assessments and CAPA implementation.
• Author and contribute to technical documents, protocols, reports and regulatory documentation.
• Maintain awareness of literature and tech developments; communicate findings to project teams.
• Collaborate with Manufacturing, Quality, Engineering and Process Development to support commercial manufacturing.
• Perform data analysis; provide technical conclusions and recommendations to internal teams.
• Ensure work complies with safety, quality, regulatory and cGMP expectations.
• Support safety programs, continuous improvement, training and knowledge-sharing activities.

Skills

Data analysis

Statistical analysis

Cross-functional collaboration

Technical writing

Regulatory documentation

cGMP awareness

Problem solving

English/Spanish bilingual

Education

Doctorate degree

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Tools

JMP software

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 effective 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

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.

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.