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Director of Process Development, Gene Therapy

GenScript

This is a Contract position in South Brunswick, NJ posted March 26, 2020.

The position is ideally suited for a professional with extensive technical knowledge and a proven track record of developing processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials, and participating in the technology transfer.

There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients, Requirements 1.

Participate the recruitment of process development and MSAT team, retain and develop talents, and provide leadership for a high performing team to meet overall business objectives.

2.

Lead the set-up of Process Development lab.

Drive the development of robust, cost-effective Lenti, AAV and other novel viral vector’s manufacturing processes, for client’s cell and gene therapy applications.

3.

Apply Quality by Design principles to develop a deep understanding of the Lenti and AAV vector platform manufacturing process and to define robust, integrated control strategies.

4.

Establish the procedures of direct tech transfers, and the capability of process lock-in pilot runs.

5.

Develop and maintain detailed and comprehensive project timelines and budgets.

6.

Lead the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.

7.

Present updates to project or upper management teams on process development and manufacturing support activities.

8.

Maintain a high level of knowledge in gene and cell therapy, sensitive in the field of T cell (CAR-T, TCR) and other novel products development and manufacturing.

9.

Perform other duties as assigned based on business needs.

Qualifications 1.

Master’s or Ph.D.

degree in Molecular Biology, Analytical Chemistry, Immunology, Chemical Engineering or equivalent with 5 years’ experience in biotech development with particular experience in gene and cell therapy product design.

Experience with Lenti, AAV process development for oncology, gene modified T cell products a plus.

2.

Technical knowledge and hands-on experience in process development of immune cell therapy technologies, gene editing and gene therapy technologies.

3.

Experience in process development for GMP-scale manufacturing with GMP requirements, familiar with small-scale models troubleshooting approach.

4.

Experience in CMC regulatory affairs for FDA, and EMA is a plus.

5.

Direct management experience with successful track record of building, coaching and mentoring a high-performing team.

6.

Strong interpersonal, verbal, and written communication skills.