Job Description:
Responsibilities Include:
- 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, as well as regulatory sections in support of IND and marketing application submissions.
- Manage multiple activities in parallel to drive project plans to completion, meeting project timelines and landmarks.
- 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 to continue innovating and to meet future business needs.
- Optimally and consistently connect with management, cross-functional partners, and relevant collaborators on progress toward breakthroughs and forthcoming program needs.
- Ability to travel domestically and internationally up to 10% of the time.
WIN
WHAT WE EXPECT OF YOU
We are all different, yet we all use our outstanding contributions to serve patients. The motivated professional we seek is a strong communicator with these qualifications.
BASIC QUALIFICATIONS:
- Bachelor’s Degree and 6 years of Scientific Experience OR
- Master's Degree and 4 years of Scientific Experience OR
- Doctorate Degree
PREFERRED QUALIFICATIONS:
- 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 fields.
- 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 experiments.
- Critical thinking, problem-solving and independent research skills.
- Strong project management skills, including the ability to lead one’s project resources (material, people, time, etc.).
- Good organizational skills with strong attention to detail
- Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally.
THRIVE
WHAT YOU CAN EXPECT OF US
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $116,160 – $138,346.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- 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
