Director Process Development
Amgen
Full-time
Remote friendly (Thousand Oaks, CA)
United States
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Role Summary
Director Process Development
Responsibilities
- Lead the development and execution of analytical and nonclinical similarity assessment strategies, including biological, biochemical, and biophysical characterization, in accordance with current regulatory guidance.
- Oversee cross-functional collaboration with Research Therapeutic Discovery, Translational & Safety Pharmacology, Clinical Development, Process Development, Quality, Manufacturing, Regulatory, Legal, and Commercial teams.
- Guide process development to achieve similarity, leveraging expertise in structure-function relationships and risk ranking of quality attributes.
- Provide scientific leadership in characterizing biochemical, biophysical, and functional properties of antibodies and recombinant proteins.
- Design and implement in vitro pharmacology study plans to demonstrate nonclinical similarity.
- Advise on statistical analysis and graphical presentation approaches for regulatory submissions, including briefing documents and dossiers.
- Author and review analytical similarity sections for regulatory submissions throughout the product lifecycle (briefing books, INDs, amendments, marketing applications).
- Lead responses to scientific questions from global regulatory agencies.
- Collaborate with internal and external partners, including contract labs, to support analytical development.
- Contribute to biosimilar publication plans and external scientific communications (oral presentations, posters, articles).
Qualifications
- Basic Qualifications: Doctorate degree and 4 years of pharmaceutical experience OR Master’s degree and 8 years of pharmaceutical experience OR Bachelor’s degree and 10 years of pharmaceutical experience. In addition, at least 4 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
- Preferred Qualifications: Advanced degree (Ph.D., Pharm.D., or equivalent) in Chemistry, Biochemistry, Biology, or related field; extensive experience in process development within the pharmaceutical or biotechnology industry with a focus on biosimilars; demonstrated expertise in analytical sciences, structure-function characterization, nonclinical pharmacology, regulatory submissions, and cross-functional leadership; strong knowledge of FDA, EMA, and global biosimilar regulatory requirements; excellent communication, collaboration, and project management skills; proven ability to mentor and lead scientific teams.
Skills
- Analytical sciences
- Structure-function characterization
- Regulatory submissions and strategies
- Cross-functional leadership
- Biochemical, biophysical, and functional properties analysis
- In vitro pharmacology study design
- Statistical analysis and data presentation
- Scientific communication and collaboration
Education
- Doctorate, Master’s, or Bachelor’s degree in relevant field; advanced degree preferred.
Additional Requirements
- Travel: Not specified as essential
- Physical demands: Not specified as essential