Associate Director, Manufacturing

Job Summary

The Associate Director (AD), Manufacturing for UNITY Biotechnology provides oversight to and management of Starting Material, Drug Substance, and Drug Product contract manufacturing organizations.

Roles and Responsibilities

  • Project Leadership and management of multiple CMO/CRO activities and manufacturing operations for projects under development (from API starting material through Drug Product), including Technology Transfer.
  • Ensure Clinical and Pre-Clinical manufacturing requirements are met ranging from supply to regulatory assistance, oversight, and audit readiness
  • Develop and participate in the process for selecting appropriate CRO/CMO and monitoring performance
  • Implementation of robust manufacturing process/systems, with associated leadership of in house project teams, and timeline management at our contract manufacturing organizations.
  • Implementation of the Unity Quality System within Manufacturing including process monitoring, process controls, KPIs, and Quality Risk Management
  • Report writing including product life cycle reports, investigation reports, change controls, protocols, development reports, regulatory filings
  • Batch Record Analysis/review, SOP preparation and review, data collection/trending, quality and supply agreement evaluation, and analysis of CMO/CRO procedures
  • Manage data and reports, agreements, batch records, procedures w/GMP Starting Material and API, and DP manufactures
  • Planning and tracking of activities and spend with
  • Managing the work of scientist at CRP/CMO organizations thru data analysis, knowledge ofinternal SOPs, and understanding Unity’s short-term/long-term goals.
  • Lead sub-groups, serve as Unity Manufacturing representative, and collaborate with otherdepartmental functions w/in Unity
  • Person in Plant as needed
  • Other Responsibilities as needed and assigned by supervisor

Qualifications

  • BS/MS/PhD with 10+ years of pharmaceutical manufacturing and outsourcing experience. Engineering, chemical engineering and or/chemistry degree preferred.
  • Strong PM, verbal communication and written communication skills
  • Knowledgeable in current GMP/GLP and regulatory requirements (US, Canada, EU)
  • Extremely motivated individual able to work with other Operations areas (Quality, Supply Chain,Regulatory CMC) involved in drug development and manufacturing to solve complex problems

Education and Experience

  • BS/MS/PhD with 10+ years of pharmaceutical manufacturing and outsourcing experience. Engineering, chemical engineering and or/chemistry degree preferred
  • Proven track record of successful project management, cross functional collaboration, especially with foreign based CRO/CMO projects where daily oversight, budget and timelines were achieved.
  • Experience with lifecycle product management
  • Be a team player in a dynamic fast paced virtual biotechnology environment where collaboration and partnership is the norm

Working Conditions

  • Office Based Position. Travel Requirement 10-40%.