Job title: Principal Scientist
Reporting to: Head of Process Development
Department: Process and Analytical Development
No of Direct reports: 0
Location: Bristol
Summary: eXmoor helps clients with their manufacturing of cell and gene therapies (CGT) and biopharmaceuticals. We provide:
translation consultancy to close the gap between R&D and clinical manufacture,process development services from our labs in Bristol,GMP manufacturing of cell and gene therapies, andcapital project design through to licensing.We are looking for a principal scientist to work in our analytical services department with particular expertise in cell-based assay development to support our clients in the clinical development of their cell and gene therapy projects. This is an exciting opportunity to work with eXmoor's globally recognised team of scientists, consultants and engineers, on a wide range of Client projects in a rapidly growing market.
Job Description: Job Purpose:
You will provide scientific expertise in assay development, with a particular focus on cell-based assays, to support eXmoor's cell and gene therapy clients within our process development and GMP manufacturing business. You will be part of a fast-growing analytical services team focusing on analytical development and QC projects using state-of-the-art technologies and in compliance with guidelines related to all aspects of CMC. This is a senior technical role that requires hands-on lab work.
Main areas of responsibility/ key duties: You will conduct your duties to the highest quality standard and in a safe way, complying with all policies and procedures and with due care and attention for yourself and your peers.You will provide scientific leadership and be a subject matter expert in analytical development to support the clinical and commercial development of cell and gene therapies.You will lead the tech transfer of a range of assays from development into QC after being developed both in-house and externally.You will encourage innovation in the wider team and eXmoor's business to support eXmoor's technical strategy.You will contribute to early technical discussions with prospective clients.You will demonstrate a forward-looking view on technology development in and around your area of expertise to support and develop eXmoor's business objectives.You will use your experience and draw from, as well as contribute to the literature to refine study objectives and protocols. You will ensure reports, protocols and presentations meet eXmoor's expected scientific and quality standards.You will author, review and/or approve study protocols and reports.You will support business development activities when required.You will contribute to the success of the wider business by supporting the GMP, TRN and Capital project teams on a range of client and internal projects.You will ensure compliance with lab documentation including risk assessments, SOPs, COSHH forms, lab notebooks and records.You will ensure safe working practices and comply with eXmoor QMS and H&S policy.You will represent eXmoor pharma externally to the broader community through the delivery of technical presentations.Person Specification: Essential Qualifications & Experience: PhD in relevant area + 6 years industry experience or BSc/MSc 10+ years of industry experience, or equivalent years experience.Established subject matter expert in analytical development with particular expertise in cell-based assays development (such as infectivity, Identity, and potency assays).Experienced in the development of QC compliant flow cytometry panels for a range of cell therapies assays.Experience with DoE and statistical analysis. Proficiency with maths and computing, including MS Office and statistics, DoE, and graphing software.Desirable Qualifications & Experience: Experience with developing infectivity assays for a range of viral therapies.Experience coaching and mentoring.Established network within the ATMP sector.Patents, publications and conference presentations.Experience in growing business opportunities.Competences Required: Organisation, planning and time management.Oral and written communication skills.Leadership and teamworking.Innovation, inquisitiveness and willingness to learn.Attention to detail and getting things finished.Problem solving.Building constructive relationships and earning respect.Motivated by growing a bio-technology business in the CGT / biopharmaceutical market.
#J-18808-Ljbffr