Job title: QC Team Lead
Reporting to: GMP Quality Manager
Department: GMP
No of Direct reports: 4+
Location: Bristol
Summary:
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 labs in Bristol, (3) capital project design through to licensing and (4) GMP manufacturing for early phase clinical trials.
The QC Team Lead will manage and maintain the GMP Quality Control activities by ensuring that the Analytical Services Laboratories work to a GMP standard.
This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants and engineers. You will work on a wide range of Client projects in a rapidly growing business whilst developing your quality management career.
Job Description:
The GMP manufacturing facility is capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The eXmoor facility comprises of two technical areas (Process / Analytical Development & GMP clinical phase production with associated QC), both working closely together such that processes developed in the PD / AD area will be transferred at scale to the GMP suites.
The QC Team Lead will be responsible for establishing, managing and maintaining the Quality Control department working with the Analytical Development department to ensure that the Analytical Services laboratories are appropriately set up to segregate between QC and process development only activities; to prevent contamination and cross contamination when performing testing. The Analytical Services area will work to a GMP standard and must comply with local and regulatory requirements. As the QC Team Lead, you will be responsible for the day-to-day scheduling and management of the laboratory QC testing for materials and products to meet the requirements under the MIA (IMP) licence and all client project needs.
Main areas of responsibility / key duties:
QC Team
* You will supervise all GMP QC Staff (Snr QC Scientists and QC Scientists) in performing their roles.
Quality System
* You will lead the QC department to ensure that QC related quality records are completed within timeframe to support metrics reporting.
* You will develop systems for the reporting of all QC testing data to QA
* You will support QC staff to ensure that quality records are completed appropriately.
* You will take the lead in OOS / OOT investigations and will support the QC team in completion of these records and will work closely with the Production and QA teams to drive them to closure.
* You will take the lead in completing quality risk assessments related to QC.
* You will develop systems and processes for communicating in process testing data with the Production team.
GMP QC Testing
* You will set up and manage systems for the trending of critical quality attributes.
* You will schedule and manage all QC sample testing for raw materials, in – process and final product & stability test samples.
* You will ensure that assays (including safety assays) are qualified / validated to an appropriate standard using a product phased appropriate approach.
* You will work with all Analytical Services team members to ensure that the area remains audit ready (these may be Supplier, Regulatory or self-inspections).
* You will control and manage the systems for testing and reference / retain samples for materials and products.
* You will work with the Production and QA teams to generate a Product Specification File and approve any sampling plans and specifications, as required.
* You will be responsible for the identifying and onboarding of new Service providers for QC testing, where required.
* You will be responsible for the development and subsequent management of stability testing programs for eXmoor Pharma.
Analytical Services Areas
* You will develop, manage and maintain GLP for the Analytical Services department.
* You will ensure that all aspects of the laboratories (including maintenance, operation, qualification, validation, material storage and waste) are managed in compliance with Cell & Gene Therapy Centres Policies and Procedures and the MIA (IMP) licence.
* You will set up and implement working practices that allow QC and AD to operate within the same Analytical Services space to the GMP Standard.
* You will ensure all QC Operational procedures are in place and kept current and up to date.
* You will ensure all laboratory equipment are appropriately assessed for data integrity requirements and manage any required remediation to ensure that all systems are compliant with local polices and procedures.
* You will lead on process improvement activities within the Analytical Services areas.
* You will ensure that any compliance, or testing, issues are escalated appropriately
Documentation
* You will develop, manage and maintain the flow of GMP QC batch related data ensuring that it is appropriately reviewed by QC prior to passing to QA.
* You will generate and sign on behalf of QC the certificate of analysis relating to products manufactured at the Cell & Gene Therapy Centre.
* You will ensure that all GMP documentation, e.g. logbooks or method record forms are reviewed in a timely manner
* You will ensure that the principles of Data Integrity and Good Documentation practice are maintained by all staff within the Analytical Services area.
You will review and approval of QC procedures prior to their implementation.
You will manage and co-ordinate QC staff to ensure that maintenance, calibration and validation activities are performed within a timely manner and are passed to QA for approval
Training
* You will identify appropriate training for laboratory staff, identifying any skills gaps to support the department development.
* You will be responsible for coaching and developing QC staff to help them achieve their goals, the team goals, and the company’s objectives.
* You will be responsible for ensuring that the QC team are appropriately trained to perform their job role and that their training records are kept current and up to date.
Safety
* You will work with eXmoor’s safety team to ensure that all health and safety measures are upheld by all laboratory staff working within the Analytical Services area.
* You will ensure that the QC team comply with laboratory and GMP documentation.
Projects
* You will take the lead and manage from a QC perspective any technical transfer of Analytical methods from our clients and will therefore be responsible for attending client calls and project team meetings.
Person Specification:
Essential Qualifications & Experience:
* Minimum BSc level education in a relevant subject area or equivalent years experience
* Considerable experience (4 years plus) working within GMP QC Operations
* Good understanding of Good Manufacturing Practice as applied to small scale biopharmaceuticals, Cell & Gene Therapies for clinical trials
* Technical expertise in analytics related to ATMPs including but not limited to HPLC, FACS, PCR, qPCR etc.
* Experience of managing a team of QC Scientists. This includes the ability to lead, develop, motivate and organise.
* Aptitude for coaching and mentoring a team
* Demonstrable understanding and experience of the following ePQS processes:
* Deviations, CAPA, non – conformance, change management, risk management, audits / self-inspections and product complaints.
* Analytical methods for Cell & Gene Therapies related to assay; purity, potency, identity, safety.
* Development of sampling plans
* Development and maintenance of stability testing programs
* Technology transfer activities Sample scheduling to ensure QC tests are performed to timeline according to the sampling plan
Desirable Qualifications & Experience:
* In depth knowledge and understanding of method development activities having worked in an assay development setting.
* Understanding and experience setting up a shared space laboratory where QC and Analytical Development activities are performed.
* Experience setting up, or using, Laboratory computer systems such as LIMs or KANBAN
* Understanding and experience in the establishment and management of the QC function
* Knowledge of Good Laboratory Practice (GLP) and routine in-process and QC assay techniques such as HPLC, PCR, sterility testing, mycoplasma testing, ELISA, SDS PAGE.
Competences Required:
* Organisation, planning and time management
* Commercially aware and able to manage procurement & budgets for QC assays.
* 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
* Proficiency in Office365 (including Word, Excel, PowerPoint).
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