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Process Development Specialist - Analytical Development

Bristol
Negotiable
Full-time
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Job title: Process Development Specialist - Analytical DevelopmentReporting to: Team LeadDepartment: Process DevelopmentNo of Direct reports: 0Location: BristolSummary:eXmoor helps clients with their manufacturing of cell and gene therapies (CGT) and biopharmaceuticals. We provide; (1) translation consultancy to close the gap between R&D and clinical manufacture, (2) process development services from our wet lab in Bristol and (3) capital project design through to licensing. We have well-funded plans to expand in all areas and to add licensed GMP manufacturing for early phase clinical trials.We are looking for an Analytical Development Specialist to join our growing AD team. You will need to have experience in developing and implementing a broad range of cell based assays across the Cell and/or Gene Therapy space, including infectivity and potency assays. You should have advanced knowledge of flow cytometry and a good understanding of the ICH guidelines around assay qualification and validation. Having expertise and experience in setting up and using automation, in particular with the Hamilton liquid handling platform would also be an advantage.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:You will be supporting the development of robust, closed and scalable GMP compliant manufacturing processes for our clients’ CGT and biopharmaceuticals.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 lead studies and support project management in the delivery of multiple, complex CGT and Biopharma process development projects that meet our client's business objectivesYou will use your experience, literature and scientific knowledge to refine study objectives and protocol• You will support project management with the management of scope changes when necessaryYou will design, execute and deliver complete work packages to support client projectsYou are responsible for managing additional operations-based activities such as EHS, equipment Maintenance or facility management to support eXmoors business objectivesYou are responsible for coaching and mentoring more junior scientists/engineersYou will manage both internal and external project stakeholdersYou will comply with lab documentation including Risk assessments, SOPs, COSHH forms, lab notebooks and recordsYou will represent eXmoor pharma externally to the broader community and will be encouraged to attend conferences and eventsYou will deliver and take part in training as requiredPerson Specification:Essential Qualifications & Experience:PhD in relevant area + 2 years industry exp.Or BSc/ MSc 5+ years industry experience.You would be developing subject matter expertise in a specific discipline relating to ATMP manufactureExperience with DoE and statistical analysis.Proficiency with maths and computing, including; MS Office and statistics, DoE, and graphing software.Desirable Qualifications & Experience:Experience in coaching and mentoringCompetences Required:Organisation, planning and time managementOral and written communication skillsLeadership and teamworkingInnovation, inquisitiveness and willingness to learnAttention to detail and getting things finishedProblem solvingBuilding constructive relationships and earning respectMotivated by growing a bio-technology business in the CGT / biopharmaceutical market
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