Job description
- Design, plan, and execute laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principles modeling, and prior knowledge.
- Develop technical project plans to generate comprehensive data packages in support of commercial formulation/process development 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 and landmarks.
- Perform data analysis using sophisticated statistical/analytical techniques with a proficiency in statistical analysis software.
- Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs.
- Effectively and consistently connect with management, multi-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs.
- Ability to travel domestically and internationally up to 10% of the time.
- Doctorate degree OR
- Master’s degree and 4 years of Scientific experience OR
- Bachelor’s degree and 6 years of Scientific experience
- 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 (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
- 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
- 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 for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
About Amgen
CEO: Robert A. Bradway
Revenue: $10+ billion (USD)
Size: 10000+ Employees
Type: Company - Public
Website: www.amgen.com
Year Founded: 1980