| Location | Rochester, New York |
R&D Scientist needs 5+ years experience
R&D Scientist requires:
* 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.
R&D Scientist duties:
* Create standard Batch Record (BTR) template for R&D and Operations to use.
* Processes include: Conjugation, Formulation, Microtiter/Microwell Plate coating.
* Formalize hands-on cross-over between R&D (Feasibility batches) & Operations (Process Ver/Val batches).
* Formalize process to set Operations coating machine parameters equivalent to R&D coating parameters.
* Standardize and document mistake proofing for light-sensitive products.
* Drive production processes transfers from a Small-Scale R&D environment into an Operations environment.