About the position
Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Responsibilities
- Work as part of a group responsible for late stage drug product formulation and process development for biologics modalities.
- Design, plan, and execute laboratory studies related to formulation and fill/finish process development.
- Develop technical project plans to generate comprehensive data packages in support of commercial formulation/process development.
- Author and review guideline documents, technical protocols, and reports.
- Author and review regulatory sections in support of IND and marketing application submissions.
- Lead multiple activities in parallel to drive project plans to completion, meeting project timelines and landmarks.
- Perform data analysis using sophisticated statistical/analytical techniques.
- Stay current on the latest developments in the industry and scientific community.
- Effectively connect with management, multi-functional partners, and relevant stakeholders on progress towards milestones.
Requirements
- Bachelor’s degree and 5 years of Scientific experience; Or Master’s degree and 3 years of Scientific experience; Or Doctorate degree PhD OR PharmD OR MD.
Nice-to-haves
- Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area.
- 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field.
- Knowledge of/experience with formulation and commercial process development for liquid and lyophilized drug products.
- Experience with unit operation specific scale down model development, characterization, and scale-up.
- Understanding of physical/chemical stability of proteins and how process related stress impacts product quality.
- Experience with coding/scripting for automated data analysis and modeling.
- Experience with data visualization tools or packages, such as Tableau or Spotfire.
- Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiment.
- Critical thinking, problem solving and independent research skills.
- Strong project management skills, including the ability to lead one’s project resources.
- Good organizational skills with strong attention to detail.
- Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally.
Benefits
- 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.
