Process Development Scientist

Amgen is currently seeking a highly knowledgeable and motivated Process Development Scientist for the development of late stage liquid and lyophilized 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. 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.

Responsibilities include:

• 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.

Basic Qualifications

• Doctorate degree or Doctorate degree completed by May 2019
• OR
• Master's degree & 4 years of scientific experience
• OR
• Bachelor's degree & 6 years of scientific experience

Preferred Qualifications

• 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
• Proficiency in lyophilization cycle development and frozen/freeze-dried solid-state characterization of large molecule biologics and additional experience with alternate modalities
• Knowledge of/hands-on experience with formulation development for lyophilized drug products
• Prior experience related to lyophilization cycle development, modelling, heat transfer characterization, scale-up, and tech transfer. Deep understanding of cycle development and optimization
• Proficiency in multiple solid-state characterization techniques (e.g. DSC, XRD, FDM, etc.) for the physical characterization of frozen and lyophilized drug product formulations
• 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
• 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.
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.

.