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Technology Transfer Scientist

Rochester, NY 14626

Posted: 03/02/24 Employment Type: 12 Months Industry: Other Job Number: 4837

Job Description

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. Create standard Batch Record (BTR) template for R&D and Operations to use. Processes include: Conjugation, Formulation, Microtiter/Microwell Plate coating.   2. Formalize hands-on cross-over between R&D (Feasibility batches) & Operations (Process Ver/Val batches). 3. Formalize process to set Operations’ coating machine parameters equivalent to R&D coating parameters. 4. Standardize and document mistake proofing for light-sensitive products. 5. Drive production processes transfers from a Small-Scale R&D environment into an Operations environment. Key Deliverables: Templates created & utilized, New deliverables in proper sequence in Standard Project Plan, Coating set-up process, update controlled docs, Process transfers validated. Core Team: TT, Operations Engineering, R&D, Quality Engineering

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