Senior Director - Analytical Development (biologics)

New york city, NY, US
Posted 6 days ago by FPC Raleigh

Job Description

Now is an exciting time to join this well-funded, clinical stage biopharma developing novel therapies. They are currently seeking a Senior Director to lead all of their Analytical CMC activities. Their lead product is a monoclonal antibody heading into Phase III shortly. The role would be very hands on and manage all analytical CMC activities (working with external CMOs/CROs - managing analytical/bioassay development and characterization activities, develop short and long term strategies, work with external consultants as needed).

Requirements -

Ph.D. in a related scientific discipline and at least 12-15 years of pharma industry experience in the analytical support (GMP) of biologics drug development leading to successful BLA submissions

A must have is someone who has had some previous experience with monoclonals

Previous experience working directly with external CMOs/CROs for outsourced work.

Must have most of their pharmaceutical industry experience within companies developing their own products (will consider someone with some CMO experience, but cannot be 100% CMO industry experience).

Travel is limited with this role (less than 20%).

Role must be based in their NYC office (no remote option).

I look forward to hearing from you!

Joanne Gehas, Ph.D.

Executive Recruiter

FPC of Raleigh

Recruiters Details

New york city, NY, US
Job number:
Joanne Gehas
Posted At:
6 days ago
Job Function:
Analytical Chemistry, Bioanalytical, Biological Science, Product Development, Research & Development
Biopharmaceutical /Biotechnology