- 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.
- Provide technical support to the CMC team and associated cross-functional project teams.
- Work closely with CMC and regulatory group to prepare appropriate regulatory submission documentation (e.g., 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
- Industry experience, within CMC for biotech or pharmaceuticals and or contract Manufacturing Management
- Experience in Project Management role, managing multiple projects
- Experience with biopharmaceutical regulatory submissions (e.g. Strong organizational and time management skills
- An analytical thinker who is energized by delving into complex projects
- Accomplishes goals within project timelines.
- Managing Self Performance
- Building collaborative relationships
- 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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Manager of Manufacturing Quality
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Manager of Manufacturing Quality - Abingdon, Oxfordshire, United Kingdom - Immunocore
Description
Senior Manager, Manufacturing and OutsourcingVacancy Name Senior Manager, Manufacturing and Outsourcing
Employment Type Full Time
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.
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.To oversee and manage the commercial or clinical manufacturing programmes chain including Drug Substance (microbial or mammalian) and Drug Product manufacture.
This role involves travel and may be upto 10 – 15%
Being flexible to new ideas and approaches; 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
Manager of Manufacturing Quality professionals in Abingdon
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Khan Mohammad Abu Imam
Analytical Chemist