Head of MSAT-Analytical Hub

GSK is currently looking for a Head of MSAT-Analytical Hub to join our team. MSAT-Analytical (MSAT-A) is responsible for the characterization (non-release) testing of biopharmaceutical drug substance and drug product and in-process samples for GSK global commercial projects. Scope for testing includes support of process development, process validation, and comparability. Supporting comparability exercises for introduction of new commercial sites and 2nd Generation processes with testing. MSAT-Analytical is also responsible for technology transfer of non-validated methods, new method development, optimization, and qualification, and analytical troubleshooting and RCA-Root Cause analysis support. The Head of MSAT-Analytical Hub provides scientific analytical and people leadership for a team of ~14 MSAT-Analytical scientists with up to 6 direct reports. All technologies for end-to-end deeper characterization of biologics from separation based HPLC, SEC- and other physiochemical assays as well as binding-based ELISA and bioassays are covered in the wet-lab in this characterization hub.

Key Responsibilities:

• Provides in depth professional and scientific advice and guidance to analysts in MSAT-Analytical and the department
• Provides in depth analytical scientific and strategic advice and guidance to assigned GSK commercial projects- Contribute actively to Analytical discussions lead by ASTLs- Analytical Science and Technology Leads in cross-functional project teams, to build analytical strategy for life-cycle development programs
• Ensures safety requirements for MSAT-Analytical lab

• Ensures MSAT-Analytical laboratory to meet the work demand in support of assigned projects, and allocates resources accordingly
• Performs or ensures review of test results and technical reports
• Provide support of product fillings with regulatory agencies
• Ensures that the people in the MSAT-Analytical group continue to develop technically and professionally and encourages their efforts toward excellence and a higher degree of proficiency
• Develops cutting edge detection strategies for various modalities and improve assays based on regulatory feedback. Champion automation initiatives for the platform and support new technologies such as multiplexing for GMP and QC.

• Collaborates and works effectively with other MSAT groups as well as other departments with GSC and R&D colleagues in a global organisation, with ability to connect/integrate with colleagues at same site and transversally at different sites. Lead external collaborations
• Identify risks on analytical feasibility, timing and resources constraints and seek a remediation plan for identified risks and escalate any technical issues to the CMC Development Team and other relevant bodies.

Basic Qualifications:

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

• BS and 12 years of experience in BioPharma/Biotechnology industry or MS and 10 years of industrial experience or PhD and 6 years of industrial experience.
• At least 3 years of managerial experience

Preferred Qualifications:

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

• Experience in Process Analytical Technologies/ Real Time Release testing approach to build innovative testing for manufacturing operations is highly preferable.
• Knowledge of analytical Quality by Design application to development is a plus.
• People Management, Coaching, innovation oriented, synthesis and analytical capacity, Influencing, Flexibility, ability to work with cross-functional teams.
• Fluent English knowledge is a must (collaboration in international environment, conferences, etc)
• Sound scientific methodology and thinking
• Excellent presentation and communication skill

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 exciting moment in our journey to get Ahead Together.

#LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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