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Director, Drug Product Development

King of Prussia, PA, US
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Summary

Cell and Gene Therapies Drug Product Development (CGDPD) is a department within a Process Development Division in Center of Breakthrough Medicines. CGDPD is responsible for drug product formulation, process development and tech transfer for manufacturing of various modalities of allogeneic and autologous cell and gene therapies. CGDPD represents a unique diverse team of scientists and engineers driving end-to-end Drug Product development efforts in advanced therapies. Director, Drug Product Development Head will play a critical role critical role in leading formulation, in-use stability and process development studies for clinical and commercial cell and gene therapy drug products. This role encompasses support of early phase development as well as late-stage BLA work packages in support of commercialization of clients’ products. The successful candidate will be responsible for driving various activities, including, but not limited to described below:

Responsibilities

  • Manage a team of scientists and engineers to develop, optimize and implement formulation and manufacturing process for cell and gene therapy drug products.
  • Drive innovations through evaluation of novel cell and gene therapy DP formulation and manufacturing approaches, identification of new instrumentation and testing of emerging platforms.
  • Plan, oversee and interpret formulation development experiments for various modalities of cell therapies such as CAR-Ts, CAR-NKs, TILs, Tregs, iPSC and others.
  • Plan and execute studies to understand and control interaction of DP with product contact material surfaces in manufacturing and clinical settings.
  • Develop robust manufacturing process and scale up procedures for engineering and GMP DP batches by applying QBD approaches as per Health Authority requirements.
  • Author/review technical reports, data summaries and CMC related documents required for regulatory submissions.
  • Design and support container closure selection and development for cell and gene therapies.
  • Lead technical discussions aimed at resolution of issues with suppliers, processes, and deviations
  • Interface with clients to establish/maintain a positive relationship, ensure expectations are clear, plan for right-first-time execution, and complete studies to successfully deliver against the program
  • Ability to work under pressure and deliver high quality clinical trial and manufacturing batches.
  • Works closely with tech transfer team to make sure that DP manufacturing processes meets requirements of target product profile.
  • Other duties as needed.

Qualifications

  • Thorough understanding of formulation and process development for novel modalities.
  • Proven track record in building and leading diverse development teams in innovator pharmaceutical companies and CDMOs is must.
  • Experience with authoring regulatory documents for IND/IMPDs and BLAs
  • Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
  • Attention to detail and quality are critical to success.

Education & Experience

  • Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 10+ years’ experience, MS with 15+ years, BS with 17+ years.

Director, Drug Product Development

King of Prussia, PA, US
Apply Now >