Amgen Inc. is seeking a Process Development Senior Scientist to join our Pre-pivotal Bioprocess Development organization. In this role, you will be responsible for developing, scaling, and transferring downstream purification processes for the early clinical manufacturing of therapeutic molecules, including monoclonal antibodies, BiTEs, and other novel modalities.
What You'll Do
- Lead a team of purification scientists to develop processes for clinical manufacturing.
- Apply technical and platform knowledge to design studies for purification process development.
- Serve in cross-functional or cross-site roles.
- Contribute to scientific literature and conferences, gaining recognition as a subject-matter expert.
- Investigate and implement relevant new technologies.
- Interface with regulatory agencies in support of CMC filings.
- Analyze and present data internally for governance and technical meetings.
- Contribute to viral clearance process evaluations and company strategies.
- Independently author technical reports, regulatory filings, patents, and peer-reviewed publications.
- Work cross-functionally to author CMC documents for Amgen’s regulatory filings.
- Develop processes to deliver multi-kilogram quantities of drug substance to cGMP operations.
- Lead deliveries of drug substance in a cGMP manufacturing environment, both internally and externally.
- Ensure that safe laboratory practices are followed.
- Provide mentoring and expertise to less-experienced staff.
What We're Looking For
- A Bachelor’s degree and 5 years of Scientific experience.
- OR a Master’s degree and 3 years of Scientific experience.
- OR a Doctorate degree (PhD, PharmD, or MD) and relevant post-doc where applicable.
Nice to Have
- Doctorate in Chemical Engineering, Biochemistry, Biology, or a related discipline.
- Experience contributing to and/or participating in purification science.
- Expertise and experience in purification process development.
- Extensive experience in development and/or support of bio-manufacturing processes, including process scale-up and GMP production.
- Track record of innovation and implementation of new technologies.
- Experience in authoring IND sections and interaction with regulatory agencies.
- Experience in viral clearance evaluation per ICH Q5A guidelines.
- Understanding of purification techniques for biological molecules (e.g., chromatography, depth filtration, viral filtration, tangential flow filtration, centrifugation).
- Capable of conveying information and recommendations on scientific issues to senior management.
- Serves as a technical authority and keeps current in relevant literature and related technology.
Technical Stack
- Chromatography
- Depth filtration
- Viral filtration
- Tangential flow filtration
- Centrifugation
Team & Environment
You will be part of the Pre-pivotal Bioprocess Development organization.
Benefits & Compensation
- Salary Range: $127,764.00 USD - $152,656.00 USD.
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models, including remote and hybrid work arrangements, where possible.
Work Mode
This position is onsite in Thousand Oaks, California.
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.
