Process Development Senior Scientist

Amgen • Thousand Oaks, CA

1d • $126,066 - $170,560

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. Process Development Senior Scientist. What you will do. Let’s do this. Let’s change the world. In this vital role you will have the opportunity to work on complex synthetic molecule platforms, including targeted protein degraders, PROteolysis TArgeting Chimeras (PROTACs), molecular glues, and other beyond-rule-of-5 compounds with challenging physicochemical and biopharmaceutical properties. The scientist will primarily design and execute formulation and process development studies for oral solid dosage forms, ranging from conventional oral solid dosage formulations to advanced enabling formulation strategies intended to overcome solubility, dissolution, absorption, and bioavailability limitations. The scientist will develop robust, scalable, and phase-appropriate formulations suitable for IND-enabling studies and GMP clinical manufacturing. This role provides significant opportunity to influence drug product strategy and advance next-generation oral delivery capabilities across Amgen’s synthetic molecule portfolio. The individual will work closely with internal manufacturing and external manufacturing partners to support process scale-up, GMP clinical manufacturing, technology transfer, and regulatory submissions. The scientist may support multiple fast-paced programs across oncology and other therapeutic areas with varying molecular and formulation complexities.

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master’s degree and 3 years of Scientific experience OR Bachelor’s degree and 5 years of Scientific experience

Nice To Haves

• Ph.D. in Pharmaceutical Sciences, Bioengineering, Chemical Engineering, Chemistry, or related scientific discipline with emphasis on oral drug product development for advanced synthetic modalities including degraders and PROTACs.
• Industry experience supporting early clinical drug product development programs preferred.
• Hands-on experience with enabling solubility formulation technologies including hot melt extrusion (HME), spray dried dispersions (SDD), and downstream processing for oral solid dosage forms.
• Experience supporting oral solid dosage form process development, scale-up, technology transfer, and GMP clinical manufacturing.
• Strong understanding of formulation development for poorly soluble compounds and enabling bioavailability enhancement strategies.
• Experience serving as a Drug Product or Formulation Development representative on interdisciplinary and multidisciplinary teams.
• Experience authoring regulatory documentation including INDs, CTAs, and related RTQs.
• Excellent interpersonal and verbal/written communication skills with demonstrated ability to manage complex cross-functional project activities.

Responsibilities

• Serve as the Drug Product Team Lead and primary Drug Product functional representative on cross-functional synthetic molecule development teams
• Independently lead drug product development strategy and execution for early clinical synthetic molecule programs
• Lead and execute drug product development activities with a focus on right-first-time delivery, proactive risk management, and on-time achievement of program milestones.
• Design and execute formulation and process development experiments for oral solid dosage forms, including platform and enabling formulations
• Apply scientific understanding of material properties, biopharmaceutics, and manufacturability to formulation strategy selection and process development
• Identify technical risks, develop mitigation strategies, and drive solutions to support program timelines and clinical objectives
• Partner effectively across internal functions and external CMOs to support program execution, technology transfer, scale-up, and GMP clinical manufacturing
• Author and review technical and regulatory documentation including INDs, CTAs and related CMC submissions
• Present technical strategies, development plans, risks, and recommendations to cross-functional teams and governance forums
• Contribute to continuous improvement initiatives and advancement of formulation and process development capabilities

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