Process Development Sr Scientist - Pivotal Drug Product
Amgen is currently seeking a Process Development Senior Scientist for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for various modalities (large molecule, RNA, virus). The Senior Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.
- Lead cross-functional Drug Product Commercialization Teams responsible for formulation development, fill/finish process development/characterization, technology transfer, and regulatory authoring for pipeline and lifecyle management projects.
- Oversee and participate in the planning, design, execution, and documentation of formulation and fill/finish process development studies.
- Manage a team of engineers and scientists to advance program and functional objectives
- Expand the utilization of advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
- Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
- Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
- Serve as subject matter expert in drug product technologies and help drive best practices and technical advancements
- Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
- Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
- Ability to travel domestically and internationally up to 10% of the time
- Doctorate degree and 2 years of scientific experience
- Master's degree and 5 years of scientific experience
- Bachelor's degree and 7 years of scientific experience
- Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related discipline
- 8 years of experience in pharmaceuticals/biotechnology
- 5 years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring
- Leadership of highly technical experts with demonstrated results driving forward pipeline and lifecycle management programs
- Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems
- Experience participating and leading global cross-functional teams
- Superior knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings
- Strong problem solving and effective cross-functional communication skills
- Proven ability to learn and act on dynamic information at a rapid pace