Senior Manager, Manufacturing and Outsourcing

1 week ago

Abingdon, Oxfordshire, United Kingdom Immunocore Full time
Job Details: Senior Manager, Manufacturing and Outsourcing

Full details of the job.

Vacancy Name

Vacancy Name Senior Manager, Manufacturing and Outsourcing

Vacancy No

Vacancy No VN232

Employment Type

Employment Type Full Time

Location of role

Location of role Abingdon

About the Company

About the Company 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. We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.

Key Responsibilities

Key Responsibilities MAIN PURPOSE OF JOB

To provide support in the evaluation, selection, and establishment of contract Manufacturing Organisations and to manage and maintain the working relationships. To oversee the technical, legal and quality agreements and negotiate financial agreements and work orders for Immunocore's drug development through all clinical phases through to commercialisation. Coordinate and support all CMC, Quality, supply and other performance management activities conducted at the CDMO on behalf of CMC and the wider Immunocore organisation. Ensuring delivery of key objectives on time/in budget delivery of Clinical and commercial material to Immunocore supply chain. KEY RESPONSIBILITIES
• To oversee and manage the commercial or clinical manufacturing programmes chain including Drug Substance (microbial or mammalian) and Drug Product manufacture.

• To manage evaluation, selection and on boarding process for CMOs and CROs.

• To oversee and lead the implementation of technical, legal and financial agreements with Contract Manufacturing Organisations.

• Develop project plans with wider CMC team and implement with CMO to deliver on time, by directly liaising with internal and external team leads.

• Align and work with Project Technical lead to ensure effective project team meetings, meeting minutes, action items and team decisions are documented

• Key senior point of contact for external CDMO to ensure maintenance of project and working relations.

• Prepare key 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.

• 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.

• 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 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.
PERSON SPECIFICATION EXPERIENCE AND KNOWLEDGE Essential

• Industry experience, within CMC for biotech or pharmaceuticals and or contract Manufacturing Management

• Experience in supplier sourcing and selection

• Experience in Project Management role, managing multiple projects

• 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

• 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 and may be upto 10 – 15% KEY BEHAVIOURAL ATTRIBUTES ALL STAFF
• Openness and honesty
Readily offering information pertaining to work in hand whether positive or negative.

• Taking responsibility
Being prepared to accept full responsibility for tasks entrusted to them; seeing tasks through to completion and dealing with the consequences of failure or success.

• Flexibility
Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively.

• Team spirit
Being able to work productively with others to achieve tasks. Showing consideration for the needs and feelings of others. SPECIFIC BEHAVIOURAL ATTRIBUTES
• Communication
Written and verbal communications are concise and appropriate, tailoring the content and the experience of the audience by using a range of tools, methods and approaches

• Managing Self Performance
Proactively seeking feedback from others and responding to this appropriately. Taking full responsibility for own performance and also the performance of others formally or informally.

• Building collaborative relationships
Developing, maintaining and strengthening partnerships with others who can provide information, assistance and support.

• Fostering teamwork
Working cooperatively with others listening, responding and offering support for ideas and proposals, whilst constructively expressing differing views.

• Influencing others
Presenting arguments that address others concerns and issues, gaining support and input from key decision makers, providing a structured approach to maximise the chances of a favourable outcome.

• Strategic thinking
Analysing the organization' approach and position by considering industry trends, internal/external existing customers and the organizations strengths and weaknesses compared to others. 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 #J-18808-Ljbffr

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