Biologics Drug Substance Leader (Associate Director)

Role Summary

Location: King of Prussia, PA. Biologics Drug Substance Leader (Associate Director) provides technical leadership of the Drug Substance process stage across multiple manufacturing sites, ensuring standardized implementation of the Product Control Strategy. You will support the Molecule Steward with technical accountability for the product, oversee process validation, regulatory filing preparation, and lifecycle support. The role leads technology transfers, validation, and continuous improvement to ensure robust, compliant, and efficient manufacturing, collaborating with R&D, manufacturing sites, and external partners.

Responsibilities

• 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.

Qualifications

• Required: Bachelor's Degree.
• Required: Minimum of 5 years of experience in biologics manufacturing or process development.
• Required: Experience in technology transfer and process validation.
• Required: Experience with GMP and regulatory requirements.
• Preferred: Experience in running a department, proven people skills to drive performance.
• Preferred: Continuous improvement mindset, with the ability to adapt to site requirements.
• Preferred: Biologics experience.
• Preferred: Demonstrated leadership in change and transformation.

Skills

• Technical leadership across multiple sites and cross-functional teams (MSAT, Production, Engineering, Quality, R&D).
• Strong knowledge of Product Quality Lifecycle Management, QbD principles, CQAs and CPPs, and Product Control Strategy.
• Experience with technology transfer, process validation, regulatory submissions, and audits.
• Ability to lead cross-functional improvement projects and CAPA-driven problem solving.
• Excellent communication and collaboration across R&D, manufacturing sites, and external partners.