Amgen Inc. seeks a Process Development Senior Scientist to join the group responsible for late-stage drug product formulation and process development. You will apply science and engineering principles to design studies and generate data packages supporting the commercial development of biologic drug products, including monoclonal antibodies and fusion proteins.
What You'll Do
- Design, plan, and execute laboratory studies related to formulation and fill/finish process development.
- Develop technical project plans to generate comprehensive data packages for commercial formulation and process characterization.
- 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.
- Perform data analysis using sophisticated statistical/analytical techniques with proficiency in statistical analysis software.
- Stay current on the latest developments in the industry and scientific community.
- Effectively and consistently connect with management, multi-functional partners, and stakeholders on progress and needs.
- Travel domestically up to 10% of the time.
What We're Looking For
- Bachelor’s degree and 5 years of Scientific experience
- Master’s degree and 3 years of Scientific experience
- Doctorate degree (PhD, PharmD, or MD)
Nice to Have
- Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics, or a related field.
- 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology.
- Knowledge of 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 the 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 in new product development, formulation development, process characterization, equipment design, technical transfers, statistical process control (SPC), and design of experiments.
- Critical thinking, problem-solving, and independent research skills.
- Strong project management skills, including leading project resources.
- Good organizational skills with strong attention to detail.
- Strong ability to operate in a fast-paced, matrixed environment and collaborate cross-functionally.
Technical Stack
- Statistical analysis software
- Data visualization tools or packages, such as Tableau or Spotfire
Team & Environment
You will be part of a group responsible for late-stage drug product development, working in a collaborative, innovative, and science-based culture focused on serving patients.
Benefits & Compensation
- Compensation Range: $127,764.00 USD - $152,656.00 USD
- 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 or sales-based incentive plan.
- Stock-based long-term incentives.
- Award-winning time-off plans.
Work Mode
This position offers a hybrid work model and is open to candidates located in the U.S. (excluding Puerto Rico).
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, disability status, or any other basis protected by applicable law.
