Biologics Drug Substance Leader (Associate Director)

Biologics Drug Substance Leader (Associate Director)

At GSK, we manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that GSK Global Supply Chain network, site goals and objectives are achieved, through a focused strategy execution. MSAT is the keeper of the body of knowledge associated with the formulation, device components, analytical testing and manufacturing unit operations, creating the instruction set and ensuring manufacturing operations stay aligned with the registered process. The primary objective is to ensure manufacturing processes are capable, compliant, in control, continuously improved and aligned across Sites. The MSAT's primary functions are to lead technology transfers, implement control strategies, provide technical process support, provide process support across the product lifecycle, while implementing new products and new modalities for commercial products and product-related improvement programs within the GSK GSC perimeter.

The Biologics Drug Substance Leader (Associate Director) role is responsible for technical leadership of a given process stage (Drug Substance). This role will provide leadership across multiple manufacturing sites to ensure the implementation of the Product Control Strategy is standardized. You will support the Molecule Steward who has technical accountability for the product. You will be responsible for process validation, supports regulatory filing activities, preparation for PAI and technical support through the product lifecycle.

This role offers an exciting opportunity to lead biologics drug substance activities across the product lifecycle. You will oversee technology transfers, process validation, and continuous improvement initiatives to ensure robust, compliant, and efficient manufacturing processes. Collaboration is key, as you will work closely with cross-functional teams, including R&D, manufacturing sites, and external partners. We value candidates who are proactive, detail-oriented, and passionate about driving innovation and operational excellence.

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.

Basic Qualifications

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

Preferred Qualifications

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

This role is based in King of Prussia, PA and requires on-site presence with flexibility for hybrid work arrangements. Join us in shaping the future of biologics manufacturing and making a meaningful impact on patients' lives.