Job Abstract

Are you energized by a impactful role that allows you to drive technology transfer, process performance qualification and commercialization for the drug substance manufacturing process for our innovative large molecule portfolio?  If so, our MSAT drug substance lead role could be an excellent opportunity to explore!

As a MSAT drug substance lead, you will engage with our process development groups, global MSAT and the new product introduction sites, and ensure that our transfer, control strategies and technical support targets are met.

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

• Ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug substance: Technical Risk Assessment, Product Control Strategy, Process Performance Qualification, Continued Process Verification and Process Robustness Assessment. Ensure risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g., CAPAs or governance boards.
• Ensure QbD principles are applied, and a robust and well understood process and product control strategy underpin technical transfer, full scale clinical development and commercialisation for new products from R&D, and lifecycle transfers to other commercial sites.
• Assess the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of Technical Risk Assessment and Product Control Strategy.
• Lead the initial technology transfer if new processes from R&D or from the MSAT process sciences groups and then to other manufacturing sites, internally and externally.  Responsible for developing DS technology transfer and PPQ strategies aligned to the new product industrialization strategy. 
• Further to the TT, work with internal or external site partners to deliver manufacturing campaigns aligned to strategy.  Provide leadership and subject matter expertise required to deliver successful PPQ campaign outcomes.
• Lead cross functional improvement projects with a clear demonstration of value created.
• Provide technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
• Respond to technical questions during regulatory submission and inspections. Recommend technical readiness to launch, including ensuring technical aspects of Transfer Acceptance Criteria are achieved.
• Provide leadership and subject matter expertise where required to support the investigation and resolution of product complaints and deviations, in-particular complex investigations.
• Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate.
• Provide technical leadership and establishes key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and with R&D.

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

• Bachelors degree in a science related field such as :Biochemical Engineering, Biotechnology
• 5 to 8yrs experience in late stage process development or MSAT roles supporting industrialization & commercialization.

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

• Experience delivering a late stage drug substance technology transfer, with an understanding of the product development process.
• Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
• Track record of improving products, processes and troubleshooting, execution of technical activities including validation activities.
• Proven problem-solving skills and ability to think and work creatively.
• Demonstrated experience in the pharmaceutical industry in leading the technical aspects of Product Lifecycle Management.
• Demonstrated knowledge of Quality by Design and risk management approaches.
• Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.
• Broad and integrated knowledge and experience that can impact project and workgroup direction. Working knowledge of regulatory requirements in the industry and drug development.
• Must have excellent verbal and written communication skills, and ability to influence, lead and drive change.
• Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO), process validation and BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, Change and Deviation Management), and knowledge management.
• Knowledge of regulatory requirements for biopharmaceutical production, including principles of quality by design. 
• Ability to support due diligence activities.

#LI-GSK

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

Why Us?

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 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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