About this role
Process Development Senior Principal Scientist
Let’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 Senior Principal Scientist will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process.
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.
Lead planning, design, execution, and documentation of laboratory studies related to drug product design, formulation, and process development, and tech transfer
Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs
Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions
Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab-scale sterile filling
Lead internal and external technology transfer activities, including collaboration with CMOs/CDMOs, process fit assessments, and troubleshooting during manufacturing campaigns
Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making
Serve as a Drug Product Team Lead of a matrixed team to develop strategy in support of commercialization and life cycle management of Amgen’s pipeline
Manage team of engineers and scientists to advance program and functional objectives
Work effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships
Ability to travel domestically and internationally up to 10% of the time
What we expect of you
We 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 PhD OR PharmD OR MD and 2 years of Scientific experience OR Master’s degree and 5 years of Scientific experience OR Bachelor’s degree and 7 years of Scientific experience
Preferred Qualifications
Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area
8+ years of experience in pharmaceuticals/biotechnology
5+ years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and regulatory authoring
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.)
Technical leader with demonstrated results driving forward programs
Experience in drug product regulatory strategy, RTQs, and agency engagement
Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems
Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), 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)
Experience participating and leading global multi-functional teams
Outstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings
Strong problem solving and effective multi-functional interpersonal skills
Willing and able to learn new technologies at a rapid pace
What you can expect of us
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
Location
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.