Director of Manufacturing

DEPARTMENT: Manufacturing
REPORTS TO: VP Operations
SUPERVISES: Process Engineering

The position manages all aspects of manufacturing, focusing on CMOs producing drug substance (cells) and drug product (biologic-device combination) for the company. The Director will develop a team to drive process engineering for future manufacturing needs through late-stage clinical trials and US commercialization. This requires tight collaborations with R&D, Quality and Regulatory to improve upon existing process and implement next-generation manufacturing.

General Responsibilities

  • Management of existing CMO producing cell banks and CMOs making biologic-device
  • Optimizes current processes and develops a next-generation process capable of supplying cells and final product for late-stage clinical trials and commercialization
  • Builds and leads a cross-functional team, dedicated to process engineering and manufacturing, that works seamlessly with key functional stakeholders
  • Acts as the company’s main point of manufacturing expertise, contributing as a technical subject matter expert
  • Has an unwavering appreciation of product integrity, patient safety and can implement systems and processes throughout manufacturing to safeguard these values

Knowledge & Skill Requirements

  • Knowledge of cGMP / ICH compliance regulations for manufacturing of cell therapies, primarily for the US / FDA market, with EU and Asian markets a bonus
  • Experience with cell culture techniques (2D & 3D), combination products (device-biologic), assays, release criteria, etc., including an understanding of evolving standards and industry best practices
  • Knowledge and experience with adherent cell cultures, ideally mesenchymal stromal cells
  • Intimate understanding and experience with the discipline of process engineering
  • Ability to work in a fast-paced, small company environment
  • Highly organized, detail oriented, results driven, and accountable for his/her team
  • Effective verbal and written communication skills, including high emotional intelligence
  • Ability to work in a collaborative group setting
  • Willingness to travel

Education & Experience

  • BS/MS or PhD in degree in pertinent biologic or engineering discipline
  • 8+ years’ experience in developing and managing FDA-regulated (clinical or commercial) cellular GMP manufacturing
  • 8+ years of senior management experience in the biopharma industry
  • 8+ direct years of relevant industry and management experience in an FDA biologics regulated environment
  • Experience in creating, or significantly contributing to, CMC sections of an IND or BLA

Contact to apply.