Senior Manager of MSAT
Posted on: January 21, 2023
ABOUT:My client is a privately-owned CDMO focused on novel Cell
and Gene Therapy medicines to meet unmet patient needs. They are a
small, biotech startup headquartered in Arcadia, CA. Their
innovative cGMP facility offers comprehensive end-to-end
manufacturing and testing capabilities for clinical and commercial
Reports to: Associate Director of Process SciencesTravel:
Occasional. Less than 10%
POSITION SUMMARY:This role will be responsible for preclinical and
clinical manufacturing support, leading a team focused on effective
delivery of MSAT operationally focused services for cGMP
manufacture of client's cell therapy products, including production
support and technology transfer. The successful candidate will have
extensive experience with cell/gene therapy processes and
- Developing a strong and deep bench of technical process experts
of cGMP cell/gene manufacturing.
- Responsible for successful transfer of processes (for
allogeneic/autologous cell therapies, viral vectors) into
production. As such, you are in direct contact with our clients,
Process Sciences and Manufacturing teams.
- Supports the various manufacturing platforms to enable current
and new product formats, increased product control, lower cost, and
lower operational complexity.
- Ensure process manufacturability and responsible for continuous
improvement of the manufacturing processes
- Lead tech transfer activities from Process Development/Sciences
to cGMP manufacturing, including the following aspects: Equipment,
Materials, Process, Documents, Training, Tech Transfer Protocol and
Report, Gap assessment and Risk assessment etc.
- Author and review of tech transfer documents, batch records,
and SOP's to support tech transfer and cGMP manufacturing
- Demonstrated ability to design laboratory experiments and
evaluate data to provide scientific guidance on process
- Demonstrated ability to technically trouble shoot and resolve
manufacturing challenges to successfully produce cell therapy
products at a high-performance rate.
- Demonstrated ability to lead investigations, risk assessments,
tech transfer, process monitoring, and routine clinical support;
experience with process characterization, PPQ and PV is highly
- Capable of suggesting effective CAPA for manufacturing process
- Deep knowledge of FDA regulatory requirements for drug products
and IND filing
- Knowledgeable of cGMP processes and technology transfer
- Ph.D. in a scientific or bioengineering discipline and 6-8
years of experience or M.S. and 8-10 years experience in MSAT or
manufacturing of cell and gene therapies (preferred), vaccines or
- At least 5 years experience of managing a technically sound,
scientific multi-functional team
- Minimum of 5 years experience in FDA-regulated industry with
experience in evaluating process materials and components in the
cell therapy biotechnology industry.
- Direct experience with cell and gene therapy process execution,
IND filing, and supporting clinical products is required.
Keywords: Meet, Covina , Senior Manager of MSAT, Executive , Covina, California
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