Sr. Director of Process Development Gene Therapy

3 weeks ago

Pennington, United States Passage Bio Full time

Summary

The Sr Director, Process Development position is a critical role for the company, serving to establish and execute a variety of development activities and strategies leading to successful development, registration, and lifecycle management of complex gene therapy products. The successful candidate will be experienced in rAAV Process Development to provide technical, operational and strategic leadership and expertise in upstream and downstream development, tech transfer and manufacturing operations in support of rAAV Gene Therapy products.


Key Responsibilities

  • Serve as a Subject Matter Expert (SME) for the development of robust, high-performing rAAV processes with emphasis on transferability to cGMP manufacturing and supports regulatory filings
  • Lead a team of process development scientists to develop rAAV candidates from early development through BLA approval
  • Develop robust, scalable, transferable processes for the production of rAAV clinical gene therapy vectors
  • Demonstrate innovative design, development, and execution of process development projects through literature review and scientific teamwork
  • Provide tactical direction to all department and site operations
  • Act as the primary SME contact to ensure effective development, tech transfer and validation of processes and analytical methods
  • Support the technology transfer for early-stage and late-stage gene therapy candidates to CDMO from internal and external partners
  • Act as the primary CMC contact with the R&D function for rAAV gene therapy preclinical assets.
  • Act as the primary CMC technical lead in regulatory filings and regulatory authorities’ interactions
  • Direct the design, development, scale-up, and technology transfer of late-stage gene therapy manufacturing processes
  • Direct process and method optimization and development of manufacturing platform across multiple products
  • Responsible for process characterization and validation strategy and execution
  • Provide SME oversight through batch record review, deviation assessment, and batch disposition
  • Write study development reports, process characterization reports, transfer documents, and regulatory documents
  • Oversee CDMO development operations
  • Assist in the generation of project and cost proposals, timelines, and work plans by applying scientific knowledge and project management experience
  • Author manuscripts and present results at scientific meetings


Required Education & Experience

  • A PhD in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant discipline and a minimum of 10 years of progressively responsible experience in gene therapy/vaccines/complex biologics process development roles
  • Experience with rAAV Gene Therapy products is preferred; experience with plasmid process development is a plus
  • Regulatory understanding of GMP biologics manufacturing as well as applicable international regulations and standards in all phases of product development and commercialization
  • Experience writing /prior success filing writing appropriate sections of CTX, NDA, BLA, MAA IND & IMPD documents
  • Proven leadership experience and people management skills
  • Knowledge and experience with process characterization and transfer is essential. Expertise in DOE and statistical analysis of data is a plus
  • Strong organizational, analytical and problem-solving skills
  • Work planning, data analysis and record keeping skills (with strong attention to detail) will be required
  • Ability to work in a fast-paced, start-up environment
  • Strong collaboration and team-building, communication, and organizational skills required
  • Experience working with and managing third-party contractors and vendors
  • Excellent written and verbal communication skills
  • Demonstrated experience with scientific and technical writing in regulatory submissions


Passage Bio is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled

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