The company is looking to solve the problem of developing biologics drug product presentations and processes, overseeing technology transfer to and manufacturing at CDMOs, and delivering robust product supply for late-stage global clinical trials and commercialization.
Requirements
- PhD in Pharmaceutical Sciences, Chemical Engineering, or Biochemical Engineering
- 12+ years (or M.S. with 15+ years) of industry experience in sterile process development for biologics
- Proven track record in advancing injectable biologics drug products, especially monoclonal antibodies in PFS, from early development through commercialization
- Experience with the device aspects of combination products, such as auto-injector
- Broad experience in cGMP biologics manufacturing and understanding of ICH regulatory guidelines
- Experience with process qualification campaign for commercial readiness for a monoclonal antibody formulation in PFS
- Strong technical leadership, project management, and cross-functional collaboration skills
Responsibilities
- Lead all aspects of biologics drug product development from early development through commercialization.
- Develop late-stage and commercial launch strategy for PFS development and manufacturing.
- Be the subject matter expert in PFS process development and sterile fill/finish manufacturing processes, providing technical guidance and strategic insights to cross-functional teams.
- Accountable for manufacturing and on-time delivery of clinical supplies from CDMOs to support late-stage global clinical trials.
- Responsible for developing phase-appropriate development strategies for drug product development, stability batches, process scale up, process characterization, process qualification (PPQ), and commercial readiness.
- Analyze, organize, and present technical development and manufacturing data at CMC meetings and identify opportunities for process improvement and optimization.
- Define and implement drug product control strategies integrated with QbD principles, as needed, to support regulatory filings and commercial readiness.
Other
- 5+ years of managerial experience in directing internal biologics development teams or at CDMOs
- Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment
- Must have a creative and strategic attitude with the ability to work in a fast-paced environment
- Strong sense of urgency and ability to deliver in a highly fast paced environment
- Require excellent written/oral communication
