Process Development Scientist - Commercial Support

Amgen • Juncos, PR

1d

About The Position

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.

Requirements

• Doctorate degree
• Master’s degree and 2 years of scientific, process development, laboratory, or manufacturing support experience
• Bachelor’s degree and 4 years of scientific, process development, laboratory, or manufacturing support experience

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree