$200K — $250K *
Passage Bio is seeking a motivated and experienced Associate Director rAAV Downstream Process Development, Gene Therapy to provide technical, operational and strategic leadership and expertise in the purification development, mid-stream and downstream operations development, tech transfer and manufacturing operations support of rAAV Gene Therapy products.
Here Is What You Will Be Doing:
· 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.
Here Is What You Will Bring To The Table:
· 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.
Valid through: 11/11/2021
$200K — $250K *
29 days ago
$100K — $150K *
3 days ago