Product Development Director jobs in Pennsylvania

• Lead the cross functional team in development of suitable manufacturing process(es), analytical methods and the manufacturing / supply network strategy from FIH clinical studies through to commercial manufacture for the given asset.
• Define the product development strategy (manufacturing and analytical) integrated with an accelerated clinical development plan and prioritise work packages for the asset accordingly.
• Act as the CMC representative during interactions with health authorities when required and stay up to date with regulatory expectations for cell and gene therapy products.
• Identify and lead the strategy when process and analytical changes are required during clinical development (e.g., comparability, analytical bridging, etc.)
• Lead the team to develop a suitable control strategy throughout clinical development and for commercial production.
• Following product approval transition the asset to a commercial supply lead but stay with the asset team to provide technical support as required.

• Provides leadership to create, implement and effectively deliver the integrated CMC product development and supply plan for a specific Adaptimmune asset throughout the drug development lifecycle.
• Be the Subject Matter Expert for the asset, with a deep understanding of the manufacturing processes, analytical methods, manufacturing network, and COGS.
• Leads the asset CMC team cross-functionally, manages the ‘creative tension’ between the various CMC & Quality functions represented on the CMC team and owns the arising decisions.
• Develops a deep knowledge of the product characteristics, manufacturing process, supply chain, materials, analytical methods and specifications, and suppliers.
• Creates tools and dashboards to communicate project status into the asset project team, CMC leadership team and governance bodies. Ensures the identification, assessment, escalation, and management of technical risk, timelines, and budget throughout the product lifecycle.
• Interface for escalation and resolution of product related issues within CMC governance groups. Be the voice of the CMC function within the asset project and study conduct teams. Additionally, be the voice of the asset project team within the CMC function.
• Collaborates with functional leaders and functional representatives to ensure that functional area resources are sufficient to achieve project goals and objectives.

• Bachelor’s degree, preferably in a relevant technical discipline, is required. Advanced degree is preferred
• Substantial and deep relevant experience within the biotechnology or pharmaceutical industry (biologic, sterile, and/or cell and gene therapy required) within a CMC or Quality function or (preferably) multiple CMC and Quality functions. 
• Working knowledge and ability to articulate experience and proficiency in the following areas:
•  Quality Operations, including an understanding and experience with ensuring GMP compliance.
• Regulatory, including an understanding of Global Regulatory requirements with regard to CMC.
• Technology, including an ability to understand and articulate experience in research and make decisions regarding innovative manufacturing technologies.
•   Supply chain considerations for cell & gene therapy products and particularly considerations unique for autologous cell therapies

• Experience leading a matrixed organization in a Regulated environment
• Experience with pharmaceutical development of cell and gene therapy drug substance and drug products
• Proven understanding of quality by design principles in drug product and process development
   

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.