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Senior Outsourcing Manager, Manufacturing

2 months ago

Oxford, United Kingdom Immunocore Full time

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.

This role supports the manufacturing and supply activities for both Clinical and Commercial products for Immunocore. Specifically, evaluating, selecting, and establishing Contract Manufacturing Organisations as part of the Immunocore Network. As well as managing and providing leadership oversight to ongoing programme and manufacturing activities. Supporting the full CMC organisation in their interactions with CDMOs, as well as corporate functional interactions such as contracting, financial management and quality oversight. The manufacturing and Outsourcing team support Immunocore's pipeline, from programming process and analytical development for phase 1 clinical batch manufacture through scale up and commercialisation. This is a vibrant and fast moving team to be part of and requires agility, a strategic mindset as well as fantastic operational management skills.

Key Responsibilities:
* To oversee and manage the commercial and/or clinical manufacturing programmes including both Drug Substance (microbial and/or mammalian manufacturing) and Drug Product manufacture.
* To manage evaluation, selection and on boarding process for CDMOs.
* To oversee and lead the implementation of technical, legal and financial agreements with CDMOs.
* Develop project plans with wider CMC team and implement with CDMO to deliver their commitments on time, by directly liaising with internal and external team leads.
* Key point of contact for external CDMO to ensure maintenance of project and working relations.
* Prepare and presentation of project and portfolio reporting documents for escalation.
* Escalate key decisions to senior management when required.
* Working with Programme Technical Leaders, ensure projects are delivered with quality, on time and on budget, by generating and managing the project timelines
* Where required supporting the Project Technical Lead to support effective CMC project team meetings, recording meeting minutes, action items and team decisions
* Support Delivery of programme by ensuring specific goals are set with realistic timeframes, prioritised and then each deliverable is tracked to ensure on-time completion.
* Contribute to problem-solving, decision-making and obtaining agreement within the team.
* Work closely with CMC and regulatory group to prepare appropriate regulatory submission documentation (e.g., pre-IND, pre-Sub, IDE, IND, IMPD, BLA, etc.)
* Involvement in of cold chain management activities to move product between suppliers, and distribution locations
* Foster communication between development, finance, and other business departments.

PERSON SPECIFICATION

EXPERIENCE AND KNOWLEDGE

Essential

* Industry specific experience is essential: proven delivery in CMC operations, and manufacturing for biotech or pharmaceuticals and/or Contract Manufacturing Management in this sector
* Proven experience in supplier sourcing and selection
* Experience in Project Management role, managing multiple projects across multiple functions
* Experience with biopharmaceutical regulatory submissions (e.g. IND IMPD BLA)
* Experience in use of PM tools and practices
* Excellent written and verbal communication skills across all levels
* Strong organizational and time management skills
* An analytical thinker who is energized by delving into complex projects to find the right path through
* A resourceful problem-solver who seeks out effective and efficient solutions
* Ability to work effectively in a highly collaborative, multi-disciplinary team setting.
* Accomplishes goals within project timelines.

Preferred

* Experience in Contract Negotiation.

This role involves travel up to 10 - 15% at peak times.

EDUCATION AND QUALIFICATIONS

* Educated to BSc level or higher in life science discipline or equivalent with appropriate industry experience proven in the working field
* Desirable: Masters/ PhD/ PharmD in related area of discipline (sciences, clinical, business, project management)
* PMP certification preferred but not necessary