Director, Integrated Drug Substance Development

Company: Jobot
Location: Cambridge
Posted on: May 16, 2022

Job Description:

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!

Job Details

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.

Essential Functions/Responsibilities
Lead and mentor scientists/engineers with upstream and downstream processing expertise.
Guide process development from lab-scale to tech transfer and GMP production.
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 regulatory submissions.
Support build-out of green field drug substance manufacturing suite.
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 organization
Along with other senior members of the CMC staff, help shape goals and strategic vision for the CMC organization.

Requirements
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 bioreactors.
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 written);

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Keywords: Jobot, Cambridge , Director, Integrated Drug Substance Development, Executive , Cambridge, Massachusetts