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 technical leadership role with accountability for the development and execution of the CMC strategy required to support delivery of the overall program goals and milestones. The role holder will serve as a Technical Operations product champion and lead a cross-functional CMC team to oversee the planning, coordination and execution of the CMC strategy and process development activities through different stages of the development cycle. 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.
Key Elements and Responsibilities
· Defines the CMC strategy for allocated programs
· Establishes and partners with the CMC team to build project timelines, milestones, risk register and mitigation plans using a risk-based approach
· Proactively interfaces with Research, Clinical, Commercial, Regulatory and Tech Ops functions to ensure the target product profiles are well defined and appropriately incorporated into the development activities
· Collaborates with Tech Ops functional leaders to allocate resources and budget to ensure successful delivery of CMC milestones from development to product launch and post approval variation management; anticipates bottlenecks and/or resource issues and escalates accordingly
· Proactively tracks and ensures CMC milestones are delivered on-time, in-full, and within budget, while ensuring compliance and high quality. Identifying and escalating issues as appropriate through appropriate governance bodies, taking full ownership of the process to drive issue resolution
· Provides strong representation for Tech Ops at Program Strategy Team level and owns the bidirectional communications between Tech Ops and the Extended Program Team. Capable of representing and championing the project and TechOps to Executive Team members as needed
· Working collaboratively with other CMC leads to continuously improve processes and ways of working
· Builds a high performing CMC 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
· Serves as a role model of Orchard’s values
Requirements
Experience & Knowledge
· Substantial Biotech/Pharmaceutical industry experience including demonstrated experience leading a multidisciplinary CMC team in a matrix setting
· Experience in the pharmaceutical sector developing ATMPs (Advanced Therapy Medicinal products with experience with HSCs and Cell & Gene Therapies would be advantageous).
Skills & Abilities
· 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
· Experience with regulatory affairs, particularly in preparing and reviewing documents for regulatory submissions (IND, NDA, BLA)
· 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
· Understanding of the drug development lifecycle with specific knowledge of ATMPS desirable
Education
· MSc or PhD in biotechnology/biological sciences, gene therapy, analytical development or an associated discipline
