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Senior Manager, QC Analytical

Company: FPC of Atlanta
Location: Levittown
Posted on: November 12, 2021

Job Description:

Senior Manager, QC Analytical
Company Description: Our client is a leading global contract development & manufacturing organization known for its scientific & operational excellence, and they currently have a need for a Senior Manager, QC Analytical---
Overall Responsibilities: Practical knowledge in all aspects of product development from investigational phase to commercial launch including method development, tech transfer, phase appropriate validation, and CMC submissions. Experience in the establishment and operation of QC laboratories in a GMP-regulated environment. Senior Manager, QC Analytical responsibilities:

  • Responsible for optimization and operations of quality control laboratory in a biopharmaceutical manufacturing setting, including all related infrastructure, documentation, equipment validation and analyst training.
  • Daily oversight of manufacturing support testing for multiple projects and related stability studies.
  • Manage all aspects of Quality Control (QC), in support of the company's GMP projects, and in full compliance with established cGMP and company's requirements.
  • Develop and implement long-term strategy, and execution of Quality Control programs.
  • Be responsible for overseeing and managing processes for the following:
  • Test method verification, qualification, validation and/or transfer activities between Assay Development and QC laboratories
  • Assay Performance Qualification and Continued Assay Verification activities associated with QC laboratory testing
  • Maintenance, calibration and qualification of laboratory instruments and equipment
  • Ensuring adequate training (skills-based, cGMP and safety) of QC scientists and associates within the department
  • Raw material, in-process, product release, stability and environmental testing
  • Investigation of laboratory non-conformances (events, deviations, and invalid assays)
  • Manage strategic capital projects for the QC labs.
  • Perform quantitative analysis and data analysis of APIs and drug products using methods such as UV-Vis, HIC, SEC, CE-SDS, iCIEF, GC, RP-HPLC and ELISA assays
  • Provide expertise in troubleshooting complex laboratory issues and demonstrate strong reasoning skills in support of ongoing laboratory investigations.
  • Manage cGMP release and stability testing at the company and contract testing laboratories.
  • Manage the implementation, qualification, validation and transfer of client's product-specific
  • methods.
  • Author and review Quality Control Standard Operating Procedures (SOPs), Assay Qualification and Stability Protocols.
    Senior Manager, QC Analytical requirements:
    • Bachelor's or higher (Scientific Degree)
    • Management Experience
    • Knowledge of HPLC, PCR, ELISA, Functional Assays, etc.
      Senior Manager, QC Analytical benefits:
      • Compensation - Competitive base salary + bonus (based on experience)
      • Medical, Dental, Vision, Vacation & 401K
      • Relocation Eligibility - Yes

Keywords: FPC of Atlanta, Levittown , Senior Manager, QC Analytical, Executive , Levittown, Pennsylvania

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