GSK is currently looking for QC Biochemistry Supervisor to join our team in Upper Merion, PA. The QC Biochemistry Supervisor provides first line supervision to QC analysts, who are responsible for in-process and BDS samples for release and stability testing. The Supervisor also serves as a leader outside of their immediate role in regard to testing and system optimization, driving continuous improvement, and participating in cross functional and cross business collaboration and teamwork.

Key Responsibilities:

• Supervise a team of front-line QC Scientists. Performs administrative duties, i.e. hiring, performance management and supporting your team's development goals
• Schedules and assures adherence to schedule for the performance of analytical testing for biochemical analysis, so that all testing to support the production and release of product lots is performed in compliance with internal procedures and standards and external regulatory standards.
• Reviews and approves investigations, change controls, protocols, validation reports.
• May review and approve biochemistry test results.
• Writes, updates, reviews, and approves Laboratory Standard Operating Procedures and Analytical Methods
• Evaluates new equipment for purchase.
• Serves as point of contact for internal and external customers for analytical testing
• Assures that laboratory equipment is calibrated and in good working condition, purchases supplies and equipment.
• Utilizes GPS tools and processes to continuously improve efficiencies and leads problem solving for laboratory test problems.
• Responsible for ensuring laboratories are operated in a state of control with regards to current LSOP's, GMP's and regulations and may serve as Biochemistry SME for internal and external regulatory audits and inspections.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS/BA degree
• Minimum of 5 years' pharmaceutical experience in a GMP regulated environment

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Demonstrated supervisory and leadership skills with ability to hold team accountable.
• Strong interpersonal and leadership skills. Solid team player able to function within team based organization.
• Strong verbal and written communication skills.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.
• Able to prioritize and decide appropriate course of actions. Effective at implementing decision.
• Fully versed in cGXP, ICH guidelines, FDA, USP/EP/JP and data integrity guidelines and regulations for analytical testing and stability
• Biopharmaceutical testing experience is preferred, ability to learn biopharmaceutical testing techniques. Assays include (but not limited to) - CGE, ELISA, CiEF, Bioassay, SEC, SPR, Protein Concentration, HPLC/UPLC, PCR, automated liquid handling
• System experience preferred - SAP/ERP, LES, Webstatistica, Empower
• Experience with MS Excel, Word, PowerPoint.
• Strong organizational skills and task management skills.
• Strong understanding of analytical methods.
• Strong data analysis, trending, technical writing, and communication (verbal and written) skills.
• Ability to solve problems.

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