Biomedical Research and Development Project Manager

Global Channel Management, Inc.
Rochester, NY Full Time
POSTED ON 6/3/2024
Experienced R&D Scientist Opportunity

Qualifications

  • Minimum of 5 years of experience in the field
  • Cross-functional Project Leadership expertise is essential
  • Preferably educated in biomedical or biochemical fields
  • Manufacturing background is highly valued
  • Prior experience in R&D is advantageous
  • Proficiency in Project Management is a plus
  • Preferred familiarity with regulated industries such as FDA and cGMP

Responsibilities

Creating Standard Batch Record Template:

  • Develop a standardized Batch Record (BTR) template for use by both R&D and Operations teams

Process Expertise

  • Handle processes including conjugation, formulation, and Microtiter/Microwell Plate coating

Facilitating Cross-over Between R&D And Operations

  • Establish a structured approach for hands-on cross-over between R&D (Feasibility batches) and Operations (Process Ver/Val batches)

Standardizing Operations Procedures

  • Formalize a process to align Operations' coating machine parameters with R&D coating parameters

Ensuring Product Quality

  • Standardize and document error-proofing measures for light-sensitive products

Production Process Enhancement

  • Lead the transfer of production processes from a Small-Scale R&D setting to an Operations environment

Employment Type: Full-Time

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