QC Biochemistry-Potency Supervisor

As a QC Biochemistry, Potency Supervisor, you will provide first line supervision to QC analysts, who are responsible for in-process, and BDS testing. You will also serve as a leader outside of your immediate role in regards to testing and system optimization, driving continuous improvement, and participating in cross functional and cross business collaboration and teamwork.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• 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 bulk, validation and finished product 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 biochemistry test results for in-process, bulk, finished products, and validation testing.
• Reviews and approves investigations, change controls, protocols, validation reports.
• Writes, updates, reviews, and approves Laboratory Standard Operating Procedures, Analytical Methods and troubleshoots laboratory test problems.
• Evaluates new equipment for purchase.
• Assesses new technologies for application to site operations.
• 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 ensured adherence to schedule.
• 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.

Why you?

Basic Qualifications:

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

• Bachelor’s Degree in a science or related discipline
• 5+ years of experience in a GxP regulated laboratory environment
• 1+ years of leadership skills (e.g. supervision, mentoring, project management, performance monitoring, coaching, training and people development)

Preferred Qualifications:

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

• 2+ years of experience with bioassay and SPR analysis
• Experience with cell culture, aseptic techniques and automated liquid handling robots (ie. Hamilton)
• Experience with large molecule/biopharm analytical testing techniques (HPLC, cIEF, CGE, ELISA, PCR)
• Strong interpersonal 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 decisions
• Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exc