Senior Director, Analytical Development
Company: Sana Biotechnology, Inc.
Location: Cambridge
Posted on: April 5, 2021
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Job Description:
Sana is seeking an exceptional Senior Leader to join our dynamic
and growing team supporting CMC development of novel gene and cell
therapy drug substances and products.-- The Senior Leader of
Analytical Development will oversee the establishment of analytical
methods and their intensive application for product and process
characterization in early development; by leveraging automation /
high-throughput testing and data analysis. With a strong focus on
both technical and operational excellence, this senior managerial
position will play a leading role in shaping core technology
platforms at Sana and the advancement of therapeutic gene and cell
therapy candidates from Research into the clinic. This role
represents an exciting and unique opportunity to shape the early
CMC development paradigm for advance therapies. DUTIES AND
RESPONSIBILITIES The experienced leader in this role will build a
world-class capability with an expert analytical team to drive
product and process understanding. The leader will manage assay
establishment, automation, testing operations, and data analysis
across a portfolio of technologies. The leader will partner closely
with process and formulation development to guide strategy and
manage analytical development in order to design quality into the
Phase 1 CMC packages for novel gene and cell therapies. The
individual will play a key role in building out the control
strategy for Sana's investigational products, and also participate
in cross-functional program teams. The successful candidate will
have industrial experience managing an analytical development team
for biologics/vaccines (and/or preferably gene/cell therapy), have
a passion for delivering results and making an impact, an interest
in technology and commitment to learning, and be an extraordinary
collaborator in a dynamic setting. The ideal leader will shape
strategy, build the capability, drive for operational excellence
and continuous improvement, and manage a high-performing team.--
Responsibilities:--
Keywords: Sana Biotechnology, Inc., Cambridge , Senior Director, Analytical Development, Executive , Cambridge, Massachusetts
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