Amgen Hiring Scientist – Biotechnology Candidates Apply Online
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us!
Job Title: PROCESS DEVELOPMENT SR SCIENTIST
Location: US, MA,Cambridge
Job ID |R-150074
Category |Operations
Eligibility Criteria:
- Doctorate degree and 2 years of scientific experience OR
- Master’s degree and 5 years of scientific experience OR
- Bachelor’s degree and 7 years of scientific experience
PREFERRED QUALIFICATIONS
- Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related subject area
- 5+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
- Knowledge of/hands-on experience with end-to-end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
- Knowledge and awareness of the regulations governing combination product development
- Experience with unit operation for both parenteral (i.e. filling, filtration, mixing, etc.) and oral solid dosage manufacturing (i.e. milling, granulation, blending, etc), specific scale-down model development, characterization, and scale-up
- Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
- Aseptic processing experience and familiarity with cGMPs, ICH guidelines, and pre-approval inspection/audits
- Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
- Strong problem solving and effective interpersonal skills, and the ability to influence colleagues with ideas.
- Previous scientific and managerial experience in support of drug product development, investigations, and regulatory filings is important.
Ability to learn and rapidly react in an environment with dynamic information.
ROLE RESPONSIBILITIES:
- Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of both parenteral and oral solid dosage presentations
Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements. - Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
- Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and cultivate strong relationships.
- Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs. - Actively utilize advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
- Ability to travel domestically and internationally up to 10% of the time.
Amgen Hiring Scientist
