JobSummary
Weare looking for GMP Production Scientist II to progress their career with us inthe exciting area of cell and gene therapies.
Youwill work within the GMP manufacturing team to execute batch manufacturing ofproducts supporting the delivery of Advanced Therapeutic medicinal Products(ATMPs). The post holder will coordinate with Production Scientist,Cleanroom Technicians and Quality Assurance and Quality Control staffto facilitate the delivery of cellular therapy products for clinicaluse.
CompanyInformation
Advent Bioservices isa growing Contract Development and Manufacturing Organisation (CDMO) providingGMP manufacturing of ATMPs and related products,process development and ancillary services. We support thedevelopment of complex, breakthrough therapies for a globally diverse market.We are at the forefront of revolutionary medicine in which life-threateningdiseases are treated using highly personalised therapies.
Responsibilitieswill include:
- Productionof cellular therapies within a sterile environment, including cryopreservationand storage. This will include cell culture and raw material support incompliance with validated standard operating procedures (SOPs) and regulatoryrequirements.
- Conductmanufacturing activities as Support, Operator or Verifier, and ensurecomplete compliance with BMRs, SOPs and GMP Regulations.
- Assist seniorstaff in the organisation and supervision of daily GMP productionhousekeeping activities, including but not limited to cleaning, environmentalmonitoring, and stock management.
- Preparetechnical reports and other clinical and GMP required documentationincluding but not limited to batch manufacturing records (BMRs),SOPs, Non-Conformances and Change Controls, working under the QualityManagement System.
- Takea lead in the completion and management of Quality tasks assigned to theProduction Team, including involvement in monthly productionquality meetings and coaching and mentoring team members in writingquality documentation.
- Assist in training staffon GMP processes including environmental monitoring, GMP cleaning,and product manufacture.
- Support technicaloperations, process engineering and validation of cellulartherapy products with full GMP compliance
- May perform linemanagement of junior staff including supervision of training andcompletion of 1:1s.
- Subject matter expertfor manufacturing related electronic systems (e.g. LIMS,EMS, eBMR).
Youwill have the following experience/qualifications:
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Provenpractical experience in a GMP laboratory (GLP/GCLP/GMP) including asepticmanufacturing of cellular therapies in a controlled clean roomenvironment
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BSc/MSc in a relevant science discipline
- Experienceleading, supervising or coordinating teams and/or projects within ascientific, manufacturing or laboratory setting.
- Experienceworking within a quality management system, including thepreparation, review and maintenance of quality.
- Workingknowledge of GMP requirements applicable to ATMPs and regulations for cell andgene therapy products.
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Experiencein contributing to Process Development within a laboratoryenvironment
- Demonstrateadaptability and resilience by responding effectively to changing priorities,demands, and operational requirements.
- Flexibleand collaborative approach with a willingness to undertake a variety of tasksto support departmentaland organisational objectives.
- Actswith integrity and professionalism, maintaining confidentiality andtaking ownership of responsibilities
- Strong organisational andtime management skills with the ability to priorities workloads
- Effectivecommunication skills, both written and verbal
- Highlevel of accuracy and attention to detail with commitment to followSOPs
We arenot accepting agency applications for this role
Candidatesmust be eligible to work in the UK
