Lab Scientist
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.
Regulated industry experience (ex: FDA, cGMP) preferred.
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.
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