Amgen Process Development Scientist in Cambridge, Massachusetts
Amgen is currently seeking a highly knowledgeable and motivated Process Development Scientist for the development of late stage liquid and lyophilized biologic drug product presentations. The position is in our Pivotal Drug Product Technologies group in Cambridge, MA, responsible for late stage drug product formulation and fill/finish process development of large molecule including proteins, monoclonal antibodies, peptides. The Scientist will work closely with a team of engineers and scientists responsible for advancing the technical aspects of Amgen’s drug product and process development. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success through the commercialization process.
Lead the planning, design, execution, and documentation of laboratory studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management.
Lyophilization cycle development, heat transfer modeling, scale-up, and frozen/freeze-dried solid-state characterization for lyophilized biologic formulations, as well as, for alternative modalities (RNA, live modalities, etc.).
Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
Participate in 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.
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.
Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
Ability to travel domestically and internationally up to 10% of the time.
Doctorate degree or Doctorate degree completed by May 2019
Master’s degree & 4 years of scientific experience or
Bachelor’s degree & 6 years of scientific experience
Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline
2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
Knowledge of/hands-on experience with formulation and commercial process development for liquid and lyophilized drug products
Experience with unit operation (i.e. filling, filtration, mixing, 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
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
Prior experience related to lyophilization cycle development, modelling, heat transfer characterization, scale-up, and tech transfer. Deep understanding of cycle development and optimization
Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function
Strong problem solving and effective cross-functional communication skills
Proven ability to learn and act on dynamic information at a rapid pace
We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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, or disability status.