CMC Lead - Cell & Gene Therapies (Technical Operations)

Location: London

Reporting to: Vice President Technical Development and CMC PM

Job Summary

The CMC Lead role within the Technical Operations organization is a key leadership role operating in a matrixed environment. It has accountability for the development and execution of the Technical Operations post-approval strategy required to support delivery of the overall program goals and milestones for a commercial Cell & Gene Therapy product. The role holder will serve as a Technical Operations product champion and lead a cross-functional CMC & operational team to oversee the planning, coordination and execution of the CMC strategy and Technical Operations Life Cycle management activities. The role holder will also serve as a key member of the Program Strategy Team (PST), representing the Technical Operations requirements at the PST and ensuring effective bi-directional communication and cross-functional collaboration, risk management and alignment.

Key Elements and Responsibilities

· Lead and execute the technical operations strategy for the product throughout its commercial lifecycle, from commercial approval through post-market activities

· Collaborate with key stakeholders to ensure alignment of technical operations & CMC activities with overall product strategy and business goals

· Key member of the Program Strategy Team (PST) & provides strong representation for Tech Ops at PST level and owns the bidirectional communications between Tech Ops and the Extended Program Team.

· Collaborate with Tech Ops functional leaders & cross-functional teams to allocate resources and budget to ensure successful delivery of project milestones from product launch through post approval variation management; anticipates bottlenecks and/or resource issues and escalates accordingly

· Establish and partner with the CMC & operational team to build project timelines, milestones, budgets, risk register and mitigation plans using a risk-based approach

· Proactively interface with Research, Clinical, Commercial, Regulatory and Tech Ops functions to develop collaborative relationships

· Collaborate with marketing, regulatory affairs, and commercial teams to support product launches, market access, and product lifecycle management

· Understand supply chain processes and liaise with the team, to ensure robustness of supply to multiple territories, ensuring regulatory compliance across regions

· Participate in risk assessments and mitigation plans related to manufacturing and supply chain challenges

· Manage the preparation and submission of CMC sections of regulatory filings and ensure ongoing compliance with regulatory requirements post-launch. May be required to represent CMC in meetings with Health Authorities

· Work collaboratively with other CMC & functional leads to continuously improve processes and ways of working

· Build a high performing cross-functional team by setting clear expectations, coaching team members and providing feedback, support and guidance to ensure that each member is enabled to provide their best performance

· Serve as a role model of Orchard’s values

Experience & Knowledge

· Substantial Biotech/Pharmaceutical industry experience including demonstrated experience leading a multidisciplinary team in a matrix setting

· Experienced in leading a cross functional team to deliver on CMC Strategy and technical lifecycle management activities for a commercial product

· Strong knowledge of Supply Chain Management

· Experience in the pharmaceutical sector developing ATMPs (Advanced Therapy Medicinal products with experience with HSCs and Cell & Gene Therapies would be advantageous)

Skills & Abilities

· Understanding of the drug development lifecycle with experience of life cycle management / commercial products with specific knowledge of ATMPS desirable

· Demonstrated strong leadership and stakeholder management skills

· Relevant industry experience in pharmaceuticals, biotechnology, or a related field, with a focus on drug development and manufacturing & supply chain management.

· Capable of representing and championing the project and TechOps to Executive Team members as needed.

· Experience with regulatory affairs, particularly in preparing and reviewing documents for regulatory submissions (MAA, BLA, Post Marketing Commitments)

· Knowledge of GMP and other regulatory standards

· Strong analytical and problem-solving skills to troubleshoot issues in drug development and production processes

· Excellent oral and written communication skills and attention to detail to ensure high quality internal presentations and regulatory submissions

· Project management skills to oversee projects from conception through to completion

· Strong interpersonal and communication skills to effectively collaborate with cross-functional teams and communicate with regulatory agencies

Education

· MSc or PhD in biotechnology/biological sciences, gene therapy, analytical development or an associated discipline

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