Job Title: VP of Manufacturing and Quality
Start-up therapeutics company developing a novel T cell platform with a focus on the discovery and development of new immunotherapies, with the aim of treating a broad range of cancers, including solid tumours, and autoinflammatory diseases.
Extensive experience in delivering GMP process development and preferably small scale GMP manufacturing with ATMPs (preferably) or other biologics in an industrial setting, including aseptic processing. Expert knowledge of EU GMP requirements and knowledge of quality requirements for ATMPs. Experience in Regulatory agency interactions for CMC activities and preparation or review of IMPDs. Knowledge and experience in analytical development. Leadership experience, including experience with line management and management and oversight of 3rd party collaborators/contractors.
The purpose of the role is to lead the strategy, planning, implementation and oversight of the; Therapeutics Process Development, Quality (CMC) and GMP Manufacturing activities for our tissue resident T cell platform. GMP manufacturing for FIH clinical trial(s) will be conducted at a CMO and process development will include both in-house and outsourced components. In addition to a first cell based therapy manufactured in the EU, the pipeline of products is anticipated to include gene modified cell therapy product(s) and biologics and include expansion of manufacturing activities to the US. This is a strategic, leadership and supervisory role.
PiR is a specialist recruitment company, established for over a decade, focused exclusively on identifying senior talent who deliver strategically and operationally to international life sciences organisations.
The relevance and depth of PiR’s expertise is reflected in the team’s combined life science recruitment experience of over 40 years; across key business functions at leadership and expert level. Our exclusive focus on, and network in, the sector ensures our solutions are aligned and relevant to client companies, reflecting our inherent understanding of the life science industry.
PiR’s client services include:
• Executive Search
• Interim Management Services
• Talent Mapping
PiR’s team is aligned to provide a depth of expertise across key business segments:
• Early stage, investor backed and SME organisations, as well as mid-capped specialist companies. These include advanced and novel therapies (cell, gene, and RNAbased), orphan drugs and innovative medical technology
• Building senior teams for newly funded and growing organisations
• Director, leadership and expert level; Medical/Medical Affairs, Clinical, Regulatory, Manufacturing Operations (including Quality and Supply Chain) and Commercial (HEOR, Pricing & Reimbursement, Market Access, product management)
• Board level appointments (CEO, CBO, COO, CSO, CMO, Chair, NED)
To learn more about PiR, please contact Sally Hope, CEO at firstname.lastname@example.org. Tel: + 44 (0) 1480 499580