QC Manager, Analytical bei Abzena

The Manager of Quality Control, Analytical is responsible for daily QC lab operations, coordination, and oversight of testing and reporting of results for raw materials, drug substance and drug product in-process, release and stability. The Manager of Quality Control, Analytical is also accountable for the oversight of method qualifications and validations, out of specification/anomalous results investigations, and will also lead process improvement opportunities; and supervise, mentor, train QC Associates. 

Responsibilities

Provides supervision to QC staff to perform duties in support of manufacturing, in support of the facility, and as necessary development activities; ensures appropriate level loading and communication of priorities. 

Responsible for optimization and operation of the quality control laboratory in a biopharmaceutical manufacturing setting, including all related infrastructure, documentation, equipment validation and analyst training. 

Develops, implements, and maintains quality control systems in accordance with cGMP requirements. 

Develops and mentors staff to improve individual and departmental performance. 

Provides daily oversight of manufacturing support testing for multiple projects and related stability studies. 

Manages all aspects of Quality Control (QC), in support of Abzena GMP projects, and in full compliance with established cGMP and Abzena requirements. 

Leads the scheduling, level loading and forecasting sample receipt and testing for the analytical laboratory. 

Oversees and manages 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) 

Strategic capital projects for the QC labs

Conducts investigations and resolves complex and non-routine issues. 

Interact closely with Manufacturing and R&D Departments. 

Provides expertise in troubleshooting complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations. 

Manages cGMP release and stability testing at Abzena, SS and contract testing laboratories. 

Manages the implementation, qualification, validation and transfer of client’s product specific 

methods. 

Authors and reviews Quality Control Standard Operating Procedures (SOPs), Assay Qualification and Stability Protocols. 

Reviews and approves Standard Test Methods, Technical and Stability Reports. 

Assists in investigation and review of deviations, change controls, CAPAs, OOT/OOS thru GMP Quality System. 

Maintains and monitors client’s product stability programs. 

Qualifications

B.S. or higher degree in Biology, or related Life Sciences degree with at least 7+ years of experience working under GMP and at least 0-3 years managerial experience. 

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. 

Extensive knowledge of U/HPLC, UV-Vis, FTIR, SDS-PAGE, ELISA, CE, and compendial assays 

Knowledge of regulatory guidelines relating to method qualification and validation 

Proven leadership and motivational capabilities. 

Experience with Data Trending and control chart interpretation. 

Knowledge with managing stability programs is desirable. 

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