Career CategoryScientific
Job DescriptionSr ScientistWhat you will doLet's do this. Let's change the world. In this vital role you will work in our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and process development for biologics modalities. The Scientist will provide technical and project support, integrating effective cross-functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgen's pipeline.
The responsibilities of this candidate will include:
- Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
- Design, plan, complete, and document formulation and process development studies
- Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
- Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
- 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 process changes/improvements and non-conformance investigations
- Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
- Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
- Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs.
- Lead cross functional initiatives enhancing Pivotal Drug Product platforms
- Manage and contribute to process design improvement projects
- Ability to travel domestically and internationally up to 10% of the time
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual with these qualifications.
Basic Qualifications:Doctorate degree PhD OR PharmD OR MD
OR
Master's degree and 3 years of Scientific experience
OR
Bachelor's degree and 5 years of Scientific experience
Preferred Qualifications:- Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related field
- Experience in pharmaceutical development and manufacturing
- Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
- Experience with development and characterization of formulations and drug product manufacturing processes
- Experience with programming, application of AI-enabled tools as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
- Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
- Critical thinking, problem solving and independent research skills
- Strong project management skills, including the ability to manage one's project resources (material, workforce, 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
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
- 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, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comSalary Range126,066.05USD -170,559.95 USD
