Career CategoryOperations
Job DescriptionProcess Development Senior Scientist What you will doLet's do this. Let's change the world. In this vital role you will join our Pivotal Drug Product Technologies group in Thousand Oaks, CA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen's Late-Stage biologics.
The ideal candidate will bring hands-on experience in ADC drug product formulation and drug product process development, including a mechanistic understanding of linker-payload attributes, stability/process-relevant degradation pathways, and analytical strategies used to characterize ADC CQAs. This candidate will integrate formulation, analytical, and process data to guide product design, apply cutting-edge technologies (including AI/ML), and collaborate cross-functionally to deliver high-quality, stable, and manufacturable drug products for development in a fast-paced environment.
- 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
- Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab-scale sterile filling.
- Build process understanding across unit operations to support scalable drug product development.
- Evaluate in-use compatibility and drug product stability under clinical conditions.
- Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making.
- Author technical documents, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and tech transfer packages.
- Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and troubleshooting during manufacturing campaigns.
- Present findings to internal/external stakeholders and participate in cross-functional teams.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications:Doctorate degree
OR
Master's degree and 2 years of
Scientific experience
OR
Bachelor's degree and 4 years of
Scientific experience
Preferred Qualifications:- PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 2-4 years of postdoc or industry experience.
- Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience is strongly preferred.
- Demonstrated understanding of ADC drug product development considerations, including linker-payload stability, drug-to-antibody ratio, free drug or payload degradation, quality attributes, and product/process comparability.
- Experience integrating formulation, stability, and analytical data to advance ADC candidates is highly desirable.
- Strong foundation in analytical and biophysical techniques relevant to ADCs and biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.).
- Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs).
What you can expect from 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.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range126,066.05USD -170,559.95 USD
