Process Development Principal Scientist
About The Position
Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Requirements
- Doctorate degree PhD OR PharmD OR MD Operations experience
- Master’s degree and 5 years Operations experience
- Bachelor’s degree and 7 years Operations experience
Nice To Haves
- Ph.D. in a relevant scientific field, such as Organic Chemistry, Physical Chemistry, Chemical Engineering, Materials Science, or Pharmaceutical Sciences.
- Strong scientific foundation with deep understanding of organic molecules and their assemblies.
- Strong scientific acumen in organic chemistry, physical chemistry, solid-state chemistry, and the physicochemical properties of small molecules.
- Pharmaceutical industry experience, preferably with oral solid dosage forms.
- Proficiency with characterization techniques, including XRPD, DSC, TGA, SEM, and related methods.
- Knowledge of patent application processes and related legal frameworks is advantageous.
- Proven experience in authoring relevant sections for market applications and responding to questions from the agency.
- Experience mentoring and developing team members.
- Comprehensive understanding of unit operations used to manufacture oral solid dosage forms.
- Ability to design, execute, and complete independent formulation research.
- Demonstrated record of scientific publication and research dissemination.
- Proven ability to collaborate effectively across cross-functional teams.
- Exceptional technical writing skills with strong attention to detail.
Responsibilities
- Serve on the Drug Product Team (DPT), developing innovative functional area strategies and designing and executing DOE studies to support late stage and commercial programs.
- Apply deep expertise in organic chemistry and their assemblies to develop innovative, fast-paced approaches as part of cross-functional teams.
- Lead Drug Product Teams as a DPTL and represent the DP function on Product Development Teams to advance late-stage assets through commercial formulation and process development, process characterization, marketing application, and post-launch commercial maintenance.
- Collaborate effectively within DPT and across Amgen functions, including Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, and Biostatistics.
- Mentor and supervise scientists.
- Design and execute experiments to support drug product development objectives.
- Summarize results in technical documents, regulatory filings, and presentations.
- Engage proactively and effectively with external industry groups, such as the IQ Consortium, and academic partners, such as university consortia.
- Provide technical expertise on the structure, reactivity, and physicochemical properties of materials, including drug substances and excipients.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
