Senior Director, Manufacturing & Outsourcing

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

The Senior Director of Manufacturing reports to the SVP of CMC and Supply Chain, and is a core member of the CMC and Supply Chain Leadership Team. Based at the Immunocore UK site, this position has a global responsibility for strategic leadership and delivery of external cGMP-compliant microbial and mammalian biomanufacturing operations at Contract Development and Manufacturing Organisations (CDMOs), for both clinical drug development and commercial supply. Leading a team with accountability for management and relationship oversight of multiple cGMP manufacturing operations in the EU and UK, overseeing technical and financial agreements, contractual relationship management, and ensuring cGMP-compliant manufacture. Accountable for the delivery and integrity of cGMP manufacturing data and information for submissions to regulatory authorities. Participation in global program and governance teams to ensure delivery of manufactured product to patients on time and within budget.

KEY RESPONSIBILITIES

1. A core member of the Immunocore CMC & Supply Chain Leadership Team, providing strategic and enterprise level leadership, direction and co-ordination, in support of CMC & Supply Chain operations.
2. Provision of regular manufacturing updates to Immunocore program and governance teams.
3. Accountable for all external cGMP manufacturing activities for Immunocore. Ensuring the logistical, scientific and regulatory integrity of manufacturing activities, to enable progression of Discovery Research, Clinical Development and Commercial supply.
4. Leads, builds, and structures the Manufacturing organisation. This position is responsible for strategic leadership and oversight of both microbial and mammalian cGMP manufacturing for Immunocore.
5. Plans, executes and provides leadership oversight of external GMP-compliant drug manufacturing, supporting bulk Drug Substance (DS) and Drug Product (DP) release and stability testing for the Immunocore drug portfolio, ensuring regulatory and quality assurance compliance.
6. Fully conversant with philosophies and regulatory guidelines pertinent to cGMP manufacturing operations. Contributes and manages the relevant manufacturing data and information included within regulatory submissions (e.g. IND, IMPD, BLA, MAA).
7. Representation and leadership within Immunocore Program teams, providing cGMP Manufacturing strategic support and technical consultancy. Contribution is made through the evaluation, recommendation and implementation of best practice.
8. Identify and champion the selection of new cGMP Contract Development & Manufacturing Organisation (CDMO) partnership opportunities, as required. Establish improvements in manufacturing technology and processes to improve efficiency, compliance and improved product understanding.
9. Proactively identify, lead and resolve manufacturing problems/barriers. This behaviour requires lateral independent thinking and innovative generation of ideas and solutions, coupled with an awareness of the appropriate technologies.
10. Effective resource management and control of annual manufacturing budgets. Plans, develops, and deploys the project specific manufacturing resource and budget plan to agreed spending targets.
11. Provides presentations and portfolio documentation to teams and upper management. Escalates key decisions to senior management, as required.
12. Participates in regular training of current Good Manufacturing Practice guidelines.
13. Involvement in Wholesale Distribution Activities, requiring training and understanding of Good Distribution Practices, as defined in Directive 2001/83/EC and various national legislations.
14. Involvement in management of cold chain distribution activities, requiring training and understanding for products requiring temperature-controlled storage and distribution.
15. Foster communication between other business departments within Immunocore and ensure that the company culture is reflected in actions and activities across the CMC & Supply Chain group.

Other

• Communicate transparently with functional heads across Research, Development, Commercial, and other business functions.
• Contribute to governance bodies and Program teams to advance drug candidates from selection through commercial lifecycle management.
• Ensure compliance and Health & Safety standards.
• Collaborate with Quality Assurance to maintain a regulatory-compliant Quality Management System for CMC & Supply Chain.

PERSON SPECIFICATION

Experience & knowledge

Essential

1. Minimum of 10 years relevant cGMP biomanufacturing experience and leadership in the biopharmaceutical industry.
2. Minimum of 5 years relevant experience with drug portfolio and people line-management.
3. Breadth of CMC development experience, including process, analytical and formulation development.
4. Experience with managing multiple projects at Contract Manufacturing Organisations.
5. Experience with early and late stage/commercial biopharmaceutical drug programs.
6. Experience with biopharmaceutical regulatory submissions (e.g. IND, IMPD, BLA, MAA).
7. Strong inter-personal and team building skills.

Desirable

1. Recognised biomanufacturing leadership track-record within the biopharmaceutical industry.
2. Working knowledge of finance and budgeting.
3. Strong organizational and time management skills.
4. A resourceful problem-solver who seeks out effective and efficient solutions.
5. Ability to work effectively in a highly collaborative, multi-disciplinary team setting.
6. Accomplishes goals within tight project timelines.

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