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QC Biochem/BioAnalytical Manager

4 months ago

Deeside Wales, Flintshire, United Kingdom RRxCo.™ Full time

RRxCo is partnered with a UK-based business established in 2010 focusing on antibody, protein and peptide drug conjugate medicines and technology. The bioconjugation team was formed in 2011 and moved into a state-of-the-art facility in 2018. The facility has been built for containment; with the safety of their people and the environment in mind, and bespoke laboratories have been designed specifically to accommodate highly potent bioconjugations.


Antibody Drug Conjugates combine the cell and tissue specificity of monoclonal antibodies with the cell-killing potential of highly potent small molecules and represent one of the fastest-growing sectors in the oncology field.


Key Notes

  • Relocation Support Provided.
  • Sponsorship Available.
  • Candidate must hold biologics experience ideally with protein/antibodies experience (this does not include ATMP/Cell & Gene Therapy).
  • Candidates must have experience in a Quality Control environment.
  • Candidates must have experience with BioChemistry/BioAnalytical/BioAssay techniques.


Summary

The QC Manager is responsible for managing and leading the QC department at Deeside. This includes personnel, equipment and facilities in the cGMP quality control function/laboratory to support the contract manufacture of parenteral protein-drug conjugate drug substances for pre-clinical, clinical and commercial use. This comprises testing of raw materials, products, process intermediates, stability and environmental samples using a variety of chemical, biochemical and microbiological methods. The manager is responsible for ensuring a state of continuous cGMP compliance and audit readiness within the QC laboratory. Alongside this and of paramount importance the manager is responsible for ensuring appropriate health and safety systems are in place for handling hazardous/toxic analytes. This is also a client-facing role that is essential to the efficient and timely delivery of multiple projects in parallel for a range of pharma clients from small biotech to large pharma, with project scope varying from quick turnarounds to strategic partnerships lasting over several years.


Deliverables

  • Lead, manage and, recruit the multifunctional Quality Control (QC) team of 16+ analysts ensuring compliant and effective training and development.
  • Work with the project and business development managers from receipt of RFPS to develop firm proposals and subsequent project delivery.
  • Ensure current Good Manufacturing Practice (cGMP) compliance.
  • Maintain a safe working environment compliant with all relevant Environment, Health and Safety (EHS) requirements.
  • Maintain and expand the cGMP QC services which encompasses chemical, biochemical, cell biology and microbiological analyses.
  • Define all equipment requirements, procure and qualify new equipment and maintain them a state of compliance; URS, DQ, IQ, OQ, PPM programs.
  • Responsible for the creation, review and approval of all necessary documentation including but not limited to analytical methods, raw material and product specifications, Certificates of testing, Stability Study Protocols, Method Qualification Protocols and Reports.
  • Manage the ongoing environmental monitoring and water testing of the GMP facility and operation.
  • Manage the investigation of out-of-trend (OOT), out-of-specification (OOS) and any deviation events.
  • Ensure that all regulatory expectations are met regarding any GMP QC samples or data collected, manipulated, reported, stored or archived.
  • Provide timely and accurate testing updates for materials, samples, products and stability studies to internal parties and external clients.
  • Has budgetary responsibility for the QC department including management of spend and equipment capital expenditure ensuring development and testing service is provided in a cost-effective manner whilst meeting key milestone deliveries.


Profile of Individual

  • Degree (preferably Masters/PhD) or equivalent in chemistry/biochemistry or a related scientific/technical field.
  • Extensive years of relevant experience in a cGMP QC laboratory with at least 5 years in a supervisory/management role with demonstratable progression in managerial responsibilities.
  • Ideally knowledge/experience of testing of protein therapeutics (ideally antibodies, more advantageous if specifically, antibody-drug conjugates).
  • Expertise in chemical, biochemical and microbiological method development, qualification, and statistical quality control.
  • Thorough knowledge of cGMP (MHRA, EMEA, FDA, MHLW, ANVISA, Health Canada, etc.) and regulatory expertise in those related to analytical method development and validation (ICH, USP, EP, JP, etc.)
  • Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOP's and technical reports.
  • Used to working in a fast-paced complex environment, able to work flexible schedules.
  • Past or current experience working with highly potent samples and associated containment and safe working practices.
  • Ideally prior experience in supporting regulatory and client audits.
  • Experience working in a CDMO, CRO or similar service provider environment is preferred.