Commercial-Stage Biopharmaceutical Company - Director of Product Development - San Diego
Rapidly growing biopharmaceutical company focused in developing & commercializing products that tailor to the lives of women is seeking a Director of Product Development (first hire).
About The Role:
Plans laboratory studies which includes the stability testing of development compounds and formulations, formulation development support.
Manages outsourced GLP/GMP studies within Product Development.
Leads the Product Development department on cross-functional teams for all projects.
Manages commercialized activities.
About The Team/Company:
Incredible team and company dynamic
Over time, help build out the Product Development team
Massive room for growth
Ability to liaison with all lines of business (Supply Chain, QA, Regulatory, etc.)
Working knowledge of GLP and cGMP requirements.
Strong writing skills and experience in contributing to regulatory filings and CMOs/CROs management.
Knowledge of regulatory guidance and requirements related to nonclinical development and CMC activities.
Semi-synthetic energy exposure
Technology, chemistry and analytical science experience
Phase 3 & 4 of life cycle experience (but also early phase)
Excellent Benefits (93% medical/dental/vision coverage, 401K match, Stock Options and more)