Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
Primary ResponsibilityThe Product Quality Lead (PQL) will be accountable for providing Quality representation and guidance for implementation of the product development and supply strategy for a specific Adaptimmune asset for GMP use. PQL has the responsibility for working with cross-functional CMC team supported by the relevant functions (Process & Analytical Development, MS&T, QC, QA, CMC Regulatory and Supply Chain). PQL serves as the voice of Quality in CMC forums. PQL will partner with Quality functions to develop and lead Quality subteams to coordinate, plan, execute and communicate Quality deliverables supporting the CMC product plans.
PQL represents the Quality product expert for the assigned asset with responsibility for providing Quality guidance and oversight of the end-to-end processes for GMP purposes. The PQL will work with the representatives from CMC to define and implement product development strategy integrated with the proposed clinical development plan, and coordinate, monitor and report Quality activities executed by responsible Quality functions to evolve the CMC development plan as clinical development progresses. The PQL will be expected to provide matrix leadership to the Quality subteam, to direct discussions, manage the creative tension on the project and between functions, and to own or support the arising decisions taken for the asset, as appropriate.The PQL lead will manage the team through all stages of the product development lifecycle from preclinical through to marketing application. Key activities are:
- Manage the creation of, and lifecycle, relevant CMC documentation, e.g., QTPP, CQA assessment, control strategy, etc. by the cross-functional team.
- 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.
Location: US (Philadelphia, PA; Boston, MA) or UK (Milton Park, Oxfordshire)Key Responsibilities
- With CMC Product Development Lead, provides leadership to support implement and effectively deliver the integrated CMC product development and supply plan for a specific Adaptimmune asset throughout the drug development lifecycle.
- Be the Quality Subject Matter Expert for the asset, with a deep understanding of the manufacturing processes, analytical methods, manufacturing network, and COGS.
- Represent Quality for the asset CMC team cross-functionally, identifies and escalates GMP or compliance gaps or requirements for asset, 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 Quality related issues within CMC governance groups. Be the voice of Quality at the CMC function within the asset project and study conduct teams, as needed. Additionally, be the voice of the asset within Quality organization.
- Collaborates with functional leaders and functional representatives to ensure that functional area resources are sufficient to achieve project goals and objectives.
- Coordinate across Quality function for the development of project plans, timelines and associated budget requirements for Quality deliverables supporting asset product and clinical development plan.
Qualifications & Experience
Required
- 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
Desirable
- 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.
