Director, Integrated Drug Substance Development
Posted on: May 16, 2022
An innovative exosome therapeutic medicine company is seeking an
experienced Integrated Drug Substance Development Director!
This Jobot Job is hosted by Amber Basinger
Are you a fit? Easy Apply now by clicking the "Apply" button and
sending us your resume.
Salary $250,000 per year
A Bit About Us
A clinical-stage biopharmaceutical company that is focused on
exosome therapeutics to treat a wide spectrum of diseases.
Why join us?
A growing company that recently transitioned its headquarters to
Cambridge, MA seeks an experienced Director to help lead its
Integrated Drug Substance Development team!
The Director is a senior role within the CMC organization,
responsible for leading an integrated drug substance development
team, responsible for advancing a lead clinical asset through
clinical development. This position will be responsible for
providing stewardship of cell culture advances across the
department, including perfusion cell culture and scale-up from lab
to manufacturing scale. Experience in early or late-stage
development with expertise in perfusion cell culture is expected
along with a nuanced understanding of phase-appropriate development
strategies. As the head of an integrated team, the successful
candidate will have a working knowledge of downstream unit
operations or an interest in expanding one's knowledge base.
Excellent communication skills and demonstrated aptitude in
collaborating across functions are essential.
Lead and mentor scientists/engineers with upstream and downstream
Guide process development from lab-scale to tech transfer and GMP
Innovate to drive development and implementation of an integrated,
continuous production process.
Interface with Research, Development, Quality, and Manufacturing
colleagues to advance clinical programs.
Collaborate cross-functionally with Regulatory to prepare
Support build-out of green field drug substance manufacturing
Conceive and implement studies to identify CPPs, CQAs and expand
exosome bioprocess understanding.
Collaborate with peer lab groups to sustain and foster a culture of
integration, innovation and continuous improvement across the CMC
Along with other senior members of the CMC staff, help shape goals
and strategic vision for the CMC organization.
PhD or commensurate years of education and experience with a
scientific degree in biology, biochemistry, biochemical
engineering, or related scientific discipline.
Typically requires 10 plus years experience (including Postdoc)
Hands on experience with bench and pilot/production scale
Experience in development and transfer of production processes for
biologics, with specific expertise desirable in perfusion cell
culture and in viral vector production;
Excellent communication and presentation skills (oral and
Interested in hearing more? Easy Apply now by clicking the "Apply"
Keywords: Jobot, Cambridge , Director, Integrated Drug Substance Development, Executive , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!