CMC Lead - Cell & Gene Therapies (Technical Operations)

Orchard Therapeutics - U.S.; London; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading company in gene therapy is seeking a CMC Lead to oversee the technical operations strategy for their commercial product. This role involves leading cross-functional teams, ensuring regulatory compliance, and managing project timelines and budgets. The ideal candidate will have substantial experience in the biotech industry, strong leadership skills, and a deep understanding of supply chain processes. Join us to make a significant impact in the field of advanced therapies.

Qualifications

• Substantial Biotech/Pharmaceutical industry experience.
• Experience leading cross-functional teams in a matrix setting.
• Strong knowledge of Supply Chain Management.

Responsibilities

• Lead and execute the technical operations strategy for the product.
• Collaborate with stakeholders to align technical operations with product strategy.
• Manage CMC sections of regulatory filings and ensure compliance.

Skills

Leadership

Stakeholder Management

Analytical Skills

Problem-Solving

Communication

Education

MSc or PhD in biotechnology

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