Director of Process Development
Posted on: June 24, 2022
The position reports to the Vice President of GenScript Probio,
US Site Head, 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
- Participate the recruitment of process development and
analytical development team, retain and develop talents, and
provide leadership for a high performing team to meet overall
- Lead the set-up of Process Development lab. Drive the
development of robust, cost-effective recombinant plasmid DNA and
other novel viral vector's manufacturing processes, for client's
cell and gene therapy applications. Lead the tech-transfer and
- Apply Quality by Design principles to develop a deep
understanding of the plasmid DNA platform manufacturing process and
to define robust, integrated control strategies.
- Establish the procedures of direct tech transfers, and the
capability of process lock-in pilot runs.
- Develop and maintain detailed and comprehensive project
timelines and budgets.
- Lead the preparation of CMC sections for regulatory submissions
(IND, Annual Reports, and BLA), invention disclosures, progress
reports, and publications.
- Present updates to project or upper management teams on process
development and manufacturing support activities.
- Maintain a high level of knowledge in gene and cell therapy,
sensitive in the field of plasmid DNA and other novel products
development and manufacturing.
- Perform other duties as assigned based on business needs.
- Up to 15% traveling to support CDMO projects or business
- 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
recombinant plasmid DNA products a plus.
- Technical knowledge and hands-on experience in process
development of immune cell therapy technologies, gene editing and
gene therapy technologies.
- Experience in process development for scale-up manufacturing
with GMP requirements, familiar with small-scale models
troubleshooting approach. Familiar with growing plasmid DNA by
microbial fermentation, lysis and chromatography purification
- Experience in CMC regulatory affairs for FDA, and EMA is a
- Direct management experience with successful track record of
building, coaching and mentoring a high-performing team.
Keywords: GenScript, Trenton , Director of Process Development, Executive , Piscataway, New Jersey
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