HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Process Development Scientist - Pivotal Drug Product Technologies
Live
What you will do
Let’s do this! Let’s change the world! In this vital role, you will work as part of a group that is responsible for late stage drug product formulation and process development for biologics modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen’s drug product and process development.
The 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.
- 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.
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:
- Doctorate degree OR
- Master’s degree and 4 years of Scientific experience OR
- Bachelor’s degree and 6 years of Scientific experience
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 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
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
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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