QC Lead

Highly Competitive
  1. Permanent
  2. Molecular Biology
  3. United Kingdom
Stevenage, Hertfordshire
Posting date: 05 Aug 2019

A growing global leader in the development, delivery and commercialisation of cell therapies have a fantastic job opening for QC Lead at their base in Stevenage. This is a dynamic and innovative organisation who pride themselves on their passion and expertise in the medical field. With more than 190 employees focusing on cell and gene therapy technologies, this organisation can offer the successful applicant the opportunity to work with a company that offers leading-edge capability, technology, and innovation.

Job Responsibilities:

  • Primarily environmental monitoring & microbiology (bioburden, rapid sterility by BacT/ALERT, chromogenic endotoxin and mycoplasma by PCR). The role will also include bioanalytical testing (rtPCR, Flow Cytometry etc.) of starting material, in-process samples and final product specification testing.
  • Leading the tactical execution of laboratory analysis and result reporting to assure the QC service provision is maintained in line with the requirements of each collaborator.
  • Emphasising and maintaining within the team a strong GMP knowledge base and work ethic
  • Maintaining a comprehensive facility environmental monitoring program..
  • Supporting the Head of Quality Control with project delivery and project management.
  • QC laboratory work scheduling and resource allocation ensuring efficient operation.
  • Technical training and coaching of the Quality Control group.
  • Analytical technical transfer of collaborator methodologies into QC.
  • Establishing a portfolio of Pharmacopoeal tests into QC.
  • Assisting in the recruitment of new employees as the group's capability expands.
  • Development of QC departmental performance measures, metrics and reporting tools and delivery of the same on periodic basis.
  • Lead Out of Specification Investigations and disposition.
  • Deputise for the Head of Quality Control when required.
  • Support microbiology test validations and method qualifications.
  • Act as a subject matter expert for microbiology-related inquiries.
  • Provide lead for aseptic process qualifications, such as aseptic gowning, good aseptic practices and media fills etc.
  • Lead microbiological Out of Specification investigations.
  • Ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards.
  • Support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity).
  • Generate, review and approve cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports etc.
  • Ensure the CGT Catapult team and associated service providers complete all documentation and records accurately, contemporaneously and to a consistent GMP standard.
  • Ensure systems are in place and being followed such that the traceability of all reagents, materials, equipment, standards etc. is maintained for all GMP sampling and testing activity.
  • Participate in Out of Trend, Out of Specification and Deviation management events associated with QC activity and act as collaborator liaison to report and manage such events to an appropriate and compliant conclusion.

Skills and Requirements:

  • Bachelor's degree in Microbiology, Biotechnology, Molecular Biology, or related discipline.
  • Member of a recognised professional body (Desirable).
  • Minimum of 5 years' experience working at a supervisory level in QC in a GMP licensed aseptic (bio)pharmaceutical manufacturing environment.
  • Expertise in the application of EU GMP to QC operations.
  • Expertise in pharmaceutical microbiology.
  • Proven experience of writing and reviewing GMP documents.
  • Proven experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements.
  • Proven experience of motivating teams, whilst training and acting as a role model for employees associated with the GMP QC laboratories.
  • Experience in interacting with the regulatory authorities.
  • Experience in interacting with clients and collaborators.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.