Process Development Senior Scientist

Amgen • Thousand Oaks, CA

1d

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. Process Development Senior Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will serve as part of the Drug Product Team (DPT) providing creative functional area strategies, crafting and executing DOE’s during the development of pivotal and commercial ready programs. This Amgen leader will apply deep expertise in organic molecules and their assemblies to develop innovative, accelerated approaches within cross-functional teams. Collaborate across DPT and with partner functions, including Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, and Biostatistics. Build effective working relationships 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. Design and execute experiments. Summarize results in technical documents, regulatory filings, and presentations. Proactively engage with external industry groups, such as the IQ Consortium, and academic organizations, such as university consortia. Provide technical expertise on the structure, reactivity, and physicochemical properties of materials, including drug substances and excipients.

Requirements

• Doctorate degree OR Master’s degree and 2 years of Scientific experience OR Bachelor’s degree and 4 years of Scientific experience

Nice To Haves

• Ph.D. in a relevant scientific field such as Organic Chemistry, Physical Chemistry, Chemical Engineering, Materials Sciences, or Pharmaceutical Sciences
• Strong scientific background for the deep understanding of the organic molecules and their assemblies.
• Profound scientific acumen with a focus on organic chemistry, Physical Chemistry, solid-state chemistry, and the physicochemical properties of small molecules.
• Industry experience: Prior work in the pharmaceutical sector, particularly with oral solid dosage forms.
• Technical proficiency: Familiarity with a wide array of characterization techniques, including but not limited to XRPD, DSC, TGA, and SEM.
• Patent process knowledge: Understanding of the patent application process and the legal framework governing patents is advantageous.
• Manufacturing insights: Comprehensive knowledge of unit operations involved in producing oral solid dosage forms.
• Research leadership: Ability to design, conduct, and complete independent formulation research.
• Publication record: Demonstrated history of research dissemination through publications.
• Team collaboration: Proven track record of effective cross-functional team engagement.
• Writing excellence: Exceptional technical writing capabilities with meticulous attention to detail.

Responsibilities

• Serve as part of the Drug Product Team (DPT) providing creative functional area strategies, crafting and executing DOE’s during the development of pivotal and commercial ready programs.
• Apply deep expertise in organic molecules and their assemblies to develop innovative, accelerated approaches within cross-functional teams.
• Collaborate across DPT and with partner functions, including Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, and Biostatistics.
• Build effective working relationships 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.
• Design and execute experiments.
• Summarize results in technical documents, regulatory filings, and presentations.
• Proactively engage with external industry groups, such as the IQ Consortium, and academic organizations, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree