Process Development Senior Scientist - Drug Product Technologies

• Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.
• Plan and execute formulation and fill/finish process studies for early-stage programs.
• 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.
• Investigate ADC- and biologics-relevant CQAs (e.g., aggregation, fragmentation, drug-to-antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.
• Leverage high-throughput tools for formulation screening and processability assessments.
• Identify and address technology gaps impacting ADC stability, linker-payload integrity, protein-excipient interactions, and process-related stress responses.
• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making.
• Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing.
• 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.

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
• OR
• Master's degree and 2 years of Scientific experience
• OR
• Bachelor's degree and 4 years of Scientific experience

• 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 from discovery or preclinical development into clinical manufacturing 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.).
• Familiarity with clinical-stage development, manufacturability, and risk-based decision-making.
• Experience applying AI/ML (e.g., LLMs, in silico tools) to streamline R&D and optimize performance.
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs).

As 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.com

In 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.