Process Development Principal Scientist

About the role

In this vital role, you will 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. This Amgen leader will apply deep expertise in organic chemistry and their assemblies to develop innovative, fast-paced approaches as part of cross-functional teams.

The Amgen DPT leader will 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.

The individual will 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.

Responsibilities

• 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.

Qualifications

Basic Qualifications

• Doctorate degree (PhD) OR PharmD OR MD and 2 years of Scientific experience
• Master’s degree and 5 years of Scientific experience
• Bachelor’s degree and 7 years of Scientific experience

Preferred Qualifications

• 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.

Benefits

Amgen offers 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
• 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

Pay

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.