Job Description

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

Requirements

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