Associate Director, 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.
To provide support in the evaluation and establishment of contract Manufacturing Organisations and to monitor and maintain the working relationships. To oversee the technical agreements and negotiate financial agreements and work orders for Immunocore’s drug development through all clinical phases through to commercialisation. Management of the CMC aspects across global, cross- functional project teams, to ensure delivery of key objectives on time and within the budget. Liaising project management functions, external contract manufacturing and research organizations to meet deliverables.
To oversee and manage the commercial manufacturing chain through to generation of bulk Drug Product
To support the initiation and oversight of the selection process for CMOs and CROs.
To oversee and lead the implementation of technical and financial agreements with Contract Manufacturing Organisations.
Develop project plans using MS Project. 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 senior 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 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 technical 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 prepare appropriate regulatory submission documentation (e.g., pre-IND, pre-Sub, IDE, IND, IMPD, BLA, etc.)
Involvement in Wholesale Distribution Activities and therefore must be trained and understand the requirements of Good Distribution Practices as defined in Directive 2001/83/EC and various national legislations (US, UK 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.
Experience and Knowledge:
In depth experience of Contract Manufacturing management.
Industry experience, within CMC for biotech or pharmaceuticals
Experience in Project Management role, managing multiple projects
Experience with biopharmaceutical regulatory submissions (e.g. IND IMPD BLA)
Familiarity with PM tools and 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.
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
- 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