Amgen Inc

Process Development Scientist – Cell Sciences and Engineering

US - Puerto Rico - Juncos

Sponsorship not specifiedDetected 1 hour ago

Data AnalysisStatisticsProcess ImprovementGMPCell CultureResearchCommunicationPublic SpeakingWritingOrganizational SkillsFermentation

About the role

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.
Our award-winning culture is collaborative, innovative, and science based.

Support process improvement initiatives, technology transfers, and implementation of data-driven solutions for Drug Substance manufacturing processes.
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.
Support department initiatives such as safety programs, continuous improvement activities, recruiting, training, and knowledge-sharing forums, as appropriate.

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.
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.
Flexibility to support non-standard shifts, on-call activities, or manufacturing operations, as required by business needs.

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,

What we expect of you We are all different, yet we all use our unique contributions to serve patients.

You will not be penalized for redacting or removing this information Sponsorship Sponsorship for this role is not guaranteed.

This listing is sourced directly from Amgen Inc's careers page and normalized into a canonical job model.