Lead drug product formulation and formulation process development in a GMP, CDMO network
Lead process scale up and characterization studies required to support drug product and formulation development life-cycle management
Lead Drug Product PPQ
Lead internal and external formulation development for injectable drug products and ultimate technical transfer(s), as applicable, of the manufacturing process to commercial manufacturing site(s)
Partner with key stakeholders and work collaboratively with cross-functional CMC, quality, regulatory, project management, legal, supply chain, and other functions to meet company goals
Author applicable drug product sections in IND and BLA filings
Establish applicable technical procedures and business process flows to support drug product life-cycle management
Requirements
Masters degree in relevant field with about 10 years industry experience preferably with biologics
Regulatory filing experience with IND preferably with BLA too
Experience submitting authoring CMC sections for single fill syringe pharmaceuticals
At least 5-7 years drug product experience with biologics.
Seniority level
Director
Employment type
Full-time
Job function
Product Management and Marketing
Industries
Primary and Secondary Education and Non-profit Organizations
Referrals increase your chances of interviewing at AL Solutions by 2x