Qualifications:
The Candidates:BS Engineers or BA Scientists with 5+ yrs professional experience. Cross-functional Project Leadership experience is required. Scope is 5-10 team members. Biomedical/biochemical education & experience is strongly preferred. Manufacturing experience is strongly preferred. R&D experience preferred. Project Management skills preferred. Regulated industry experience (ex: FDA, cGMP) preferred.
Responsibilities:
1. Operations Requirements Document (ORD) Restructure. Scope includes 1 site in Rochester NY & 1 site in the UK. 2. Drive production processes transfers from a Small-Scale R&D environment into an Operations environment. Key Deliverable: A complete ORD that will be used to communicate process &/or validation boundaries to R&D. Process transfers validated. Core Team: TT, Operations, Operations Engineering, Quality Engineering.
