Process Development Scientist- Drug Substance Purification

Amgen • Juncos, PR

3d

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- Drug Substance Purification. What you will do Let’s do this. Let’s change the world! In this vital role, you will join the Drug Substance Purification 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.

Requirements

• 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
• Strong technical skills, including scientific analysis, experimental execution, data interpretation, basic statistic knowledge, and problem solving.
• Ability to apply data-driven approaches to process improvement and technical decision-making.
• 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.
• Proficiency in computer applications such as Word, Excel, PowerPoint, and statistical analysis or data visualization tools.
• Ability to work collaboratively in cross-functional teams and adapt to changing business needs.

Nice To Haves

• Educational background in Life Sciences, Biotechnology, Chemical Engineering, Biochemical Engineering, Biology, Chemistry, or related Engineering or Scientific discipline.
• Experience in biopharmaceutical process development, Drug Substance manufacturing support, cell culture, purification, process characterization, or technology transfer.
• Understanding of regulated manufacturing environments, cGMPs, quality systems, and regulatory expectations.
• Experience supporting deviation investigations, troubleshooting, root cause analysis, and corrective action implementation.
• Bilingual communication skills in English and Spanish, written and verbal.
• Flexibility to support non-standard shifts or manufacturing operations, as required by business needs.

Responsibilities

• 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.

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: Mid Level