• Rochester, New York
  • Autofill and Review
30+ days ago

Job Description

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.

Numbers & Facts

LocationRochester, New York
Websitehttps://www.globalchannelmanagement.com/

Skills

  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • FDA (Food and Drug Administration)unmatched
  • Leadershipunmatched
  • Manufacturingunmatched
  • Operations Processesunmatched
  • Project/Program Managementunmatched
  • Research & Development (R&D)unmatched
  • Standards Developmentunmatched

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