Job Overview:        

 

Passage Bio is seeking a motivated and experienced Sr. Director Process Development, Gene Therapy to provide technical, operational and strategic leadership and expertise in the purification development, mid-stream and operations development, tech transfer and manufacturing operations support of rAAV Gene Therapy products.

 

Responsibilities:

 

·       Serve as a Subject Matter Expert (SME) for the development of robust, high performing downtream processes with emphasis on transferability to cGMP manufacturing and supports regulatory filings.

·       Develop robust, scalable, transferable processes for downstream production of rAAV clinical gene therapy vectors.

·       Demonstrate innovative design, development, and execution of process development projects through literature review and scientific teamwork.

·       Responsible for chromatographic and physical separations (TFF) development and bulk drug substance development operations. 

·       Provide tactical direction to all related department operations.

·       Manage all subject matter experts (SMEs) for both internal and external (CDMO) projects in all areas of process development.

·       Act as the primary SME contact with the CDMO 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, 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 presents results at scientific meetings.

 

Requirements:

 

·       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