Sr. Manager/Associate Director Manufacturing
The Sr. Manager/Associate Director Manufacturing gives oversight to and management of Starting Material, Drug Substance, 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 of internal SOPs, and understanding Unity’s short-term/long-term goals.
- Lead sub-groups, serve as Unity Manufacturing representative, and collaborate with other departmental functions w/in Unity
- Person in Plant as needed
- Other Responsibilities as needed and assigned by supervisor
- MS/PhD with 10+ years in small molecule pharmaceutical manufacturing, development, and outsourcing. A background in pharmaceutical sciences, chemical engineering, and/or quality control 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.
- Strong PM, verbal communication and written communication skills
- Knowledgeable in current GMP/GLP and regulatory requirements (US, Canada, EU)
- Experience with lifecycle product management
- 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
- Be a team player in a dynamic fast paced virtual biotechnology environment where collaboration and partnership is the norm
- Travel Requirement 10-30%