Senior Manager, Manufacturing and Outsourcing
91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
The Senior Manager, Manufacturing and Outsourcing provides support in the evaluation and establishment of contract Manufacturing Organisations and monitors and maintains working relationships. This person supports the oversight of the technical agreements and work orders for Immunocore’s drug development through clinical phases, and the establishment of continued integration of formal project and portfolio management into Immunocore’s drug development processes. The Senior Manager, Manufacturing and Outsourcing provides ongoing leadership in the planning of individual projects specific to the area of CMC. This involves managing global, cross- functional project teams (UK, EU and US based), to ensure delivery of key objectives on time and within the budget.
- To support the initiation and oversight of the selection process for CMOs and CROs.
- To support the implementation of technical and financial agreements with Contract Manufacturing Organisations.
- Develop project plans using appropriate software tools. Implement and continually monitor progress against project plans and revise, by directly liaising with internal and external team leads.
- Facilitate effective project team meetings and ensure meeting minutes, action items and team decisions are documented.
- Key point of contact for external CMO/CROs to ensure maintenance of project and working relations.
- Prepare key project and portfolio summary documents for teams and upper management. Preparing presentations as required. Escalate key decisions to senior management when required.
- Working with Programme Leaders, ensure projects are delivered with quality, on time and on budget, by generating and managing the CMC project plans.
- Reinforce deadlines, ensuring specific goals are set with realistic timeframes, prioritised and then each deliverable is tracked to ensure on-time completion.
- Provide general operational support to the CMC team and associated cross-functional project teams.
- Contribute to problem-solving, decision-making and obtaining agreement within the team.
- Work closely with CMC and regulatory group to assist in the preparation of appropriate regulatory submission documentation (e.g., pre-IND, pre-Sub, IDE, IND, IMPD, etc.)
- Foster communication between development, Quality, Regulatory, finance, and other business departments.
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
- Industry experience, within CMC for biotech or pharmaceuticals
- Experience in Project Management role, managing multiple projects
- Familiarity with PM practices
- Excellent written and verbal communication skills across all levels
- Strong organizational and time management skills
- A fast learner that leverages core talents and skills rapidly in new and complex environments
- An analytical thinker who is energized by delving into complex projects
- 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.
Lead with Science and Discover What is Within:
- We Value Entrepreneurship and Diversity
- Respect, Trust, and Integrity
- Competitive compensation
- Private medical and dental benefits.
- 25 days Annual Leave and Bank Holidays
- 4x Salary Life Insurance
- 5% Pension Match
- Income Protection
- Parental Leave