Location of role

Oxford, UK

Department: CMC

Main Purpose of Job:

The primary purpose of this role is to leverage emerging expertise and subject matter knowledge in the development and manufacture of protein-based biotherapeutics through a network of external vendors to address significant and unique complex issues, aligning work with the wider Immunocore’s strategy. The individual will interpret internal and external business challenges, recommend best practices, and identify new solutions to improve products and processes. They will make timely, tough decisions, effectively dealing with ambiguity and limited information.

The role involves developing and executing the strategy for developing and manufacturing next generation ImmTAX candidates produced by mammalian expression to meet the clinical needs of the company, with potential contributions to other areas. The incumbent will be expected to maintain strategic awareness of the market, competitive landscape, and opportunities, understanding the impact of their decisions on short-term and long-term results. They will interact proactively with key stakeholders, influencing, negotiating, and persuading on difficult concepts, and regularly presenting at high-profile meetings.

Leadership is a key component, with responsibilities including leading functional teams or projects, serving as a best practices resource, and providing guidance, coaching, and mentorship to professional and managerial employees. Advanced project management skills are essential, with a focus on managing changing priorities, motivating the team, fostering a climate of creativity and empowerment and forging strong and collaborative relationships across internal and external teams. The individual will create a safe environment for learning, development and challenge within cross-functional project teams. The role requires (if applicable: effective coaching skills), the ability to bring vision and strategy to life, engage with stakeholders across all areas of the business and the capacity to engage in difficult conversations to inspire action and create a sense of purpose.

Key Responsibilities:

• Build market knowledge of competitive processes, timelines and suppliers for Mammalian Manufacturing
• Work collaboratively with project teams and SMEs to develop CMC strategy for onboarding and progressing new mammalian candidates
• Initiate and oversee the selection process for Contract Development Manufacturing organisations for CMC development and cGMP manufacture of ImmTAX molecules by mammalian expression
• Build the external collaborations to facilitate expedited entry of new molecules into the clinic
• Oversee and lead the technical and financial agreements with Contract Development Manufacturing organisations
• Working with CMC project leads, ensure appropriate CMC project plans are written within Project Management software for mammalian-based programmes, linked to global project timelines. Implement and continually monitor plans, ensuring progress to plan
• Build a culture of effective project team meetings and ensure meeting minutes, action items and decisions are documented
• Supply key project and portfolio summary documents for teams and upper management
• Presentation to senior leadership and governance bodies as required for awareness, endorsement and decision making
• Work with CDMOs to ensure projects are delivered with required quality, on time and on budget
• Represent CMC in collaboration with QA and regulatory groups to prepare appropriate regulatory submission documentation (e.g., pre-IND, pre-Sub, IDE, IND, IMPD, BLA, etc.)
• Involvement in all aspects of cold chain management activities and therefore must be trained to understand the sensitive nature of products requiring temperature-controlled storage and distribution
• Foster communication between development, finance, and other business departments and ensure that the company culture is reflected in actions and activities across the CMC group
• Cultivate strong links with Research to facilitate streamlined onboarding of new molecules into CMC development and ensure build out of future manufacturing needs to meet projected pipeline