Immunocore is an innovative and dynamic biotechnology company developing a unique platform of T Cell antigen receptor-based therapeutics, called ImmTAXs, as a novel class of treatments for cancer, infectious and autoimmune diseases. Immunocore has a well- established pipeline of wholly owned programmes, of world leading science and strong IP position, which has led to discovery collaborations with Genentech, GlaxoSmithKline, Medimmune as well as a co-discovery & co-development partnership with Lilly, and recent investment from the Bill & Melinda Gates Foundation.
We are now seeking a Stability Manager to join our CMC team. This position is responsible for providing the strategy and implementation of both a Drug Substance and Drug Product Shelf life for each ImmTAC platform candidate progressing in to a clinical or commercial environment. Supported by a team of Stability Coordinators, the role will have oversight of both Development studies at Immunocore and Engineering / GMP studies at CMOs. Assurance of Quality and Data Integrity from all studies is integral to the functional area, with responsibility for authoring related sections of regulatory submissions to EU and US authorities. The Stability Studies Manager is also responsible for providing input to additional product stability related activities at Immunocore, including but not limited to, assessing temperature excursions for clinical materials, managing shipping validation for commercial bulk materials, and supporting the stability of Critical Reagents supplied for Quality Control test methods.
- Manage the CMC Stability function activities within Immunocore Health and Safety policies.
- Management and oversight of all GMP (and non-GMP) Drug Substance and Drug Product stability studies performed at CMOs.
- Management and oversight of all Drug Substance and Drug Product stability Development operations for Immunocore.
- Managing a team of Stability Coordinators, providing direction and support to their activities, goals and role progression, in alignment with current business requirements.
- Proactive reporting of Product Stability functional updates across the CMC leadership team and within CMC Project Teams.
- Propose, implement and manage the Drug Substance and Drug Product Shelf life strategies for each ImmTAC platform candidate progressing in to a clinical or commercial environment.
- Manage the input, and author the Drug Substance and Drug Product Stability related sections included within EU & US regulatory submissions, ensuring both Data Integrity and Quality.
- Implement, maintain and support adherence to defined quality procedures and processes across the stability function.
- Documentation and assessment of Quality Events related to product stability processes both in the Immunocore Development and CMO GMP environments.
- Collaborate with the Immunocore Analytical Development function to ensure the availability of controlled stability indicating methods for continuous monitoring of Key Product Quality attributes, both through Qualification at Immunocore, and following technical transfer and validation at CMOs.
- Support the compilation and evaluation of stability product degradation profiles and the output from forced degradation studies performed by the Immunocore Analytical Development Scientists.
- Oversight of procedures and continuous monitoring of Immunocore Control Storage Units supporting Development Stability studies.
- Collaboration with CMC functional area representatives to support the stability and expiry of critical reagents used in Quality Control test methods.
- Responsible for assessing Temperature Excursions on Bulk Drug material and clinical supply materials either at site storage or during shipping activities.
- Manage Shipping Validation studies to support Commercial Bulk Product Distribution.
EXPERIENCE AND KNOWLEDGE
- Proven accomplishments in Analytics, method validation, Quality Control / GMP Testing and Product Stability in a biopharmaceutical environment and / or for a Biological Product.
- Line management and leadership experience, including building and managing a high performing team, ensuring the assessment and provision of Health & Safety appropriate to their roles.
- Proven success with initiating, performing, reporting and evaluating Stability Studies, ensuring Data integrity for input to regulatory submissions.
- Experience authoring regulatory submission sections for EU and USs, with direct input and communication with agency representatives and experience of product commercialisation being advantageous.
- Expertise with biopharmaceutical stability study principles and associated regulatory guidelines.
- Proven Experience of managing work at GMP-compliant Contract Manufacturing Organisations.
- Experience with Statistical software packages to support trending and data evaluation.
- Presentation of scientific findings and papers to internal and external audiences.
- Working knowledge of finance and budget control.
- Strong relationship building skills.
KEY BEHAVIOURAL ATTRIBUTES
- Openness and honesty - readily offering work information, 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 and motivate colleagues to achieve tasks. Showing consideration for the needs and feelings of others.
We look forward to hearing from you!