Hybrid CMC Lead - Cell & Gene Therapies (Technical Operations) bei Orchard Therapeutics

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