Senior Manager, QC Analytical
Company: FPC of Atlanta
Posted on: November 12, 2021
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
- 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
- Test method verification, qualification, validation and/or
transfer activities between Assay Development and QC
- 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
- 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
- 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
- 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
- Medical, Dental, Vision, Vacation & 401K
- Relocation Eligibility - Yes
Keywords: FPC of Atlanta, Levittown , Senior Manager, QC Analytical, Executive , Levittown, Pennsylvania
Didn't find what you're looking for? Search again!