Job title:Senior Analytical Services Scientist
Reporting to:Interim Head of Analytical Services
Department:GMP
No of Direct reports:1+
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 and (3) capital project design through to licensing and (4) licensed GMP manufacturing for early phase clinical trials.
The Senior Analytical Services (AS) Scientist will support the Head of GMP in establishing, managing and maintaining the GMP analytical Quality Control function.
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 will be capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The eXmoor facility will comprise three technical areas (Process Development (PD), shared AS including QC & GMP clinical phase production), both working closely together such that processes developed in the PD/AS area will be transferred at scale to the GMP suites and GMP QC.
The Senior AS Scientist will be responsible for managing and maintaining the GMP QC analytical function ensuring the laboratory and QC testing for materials and products meets its requirements under the MIA (IMP) licence and ensuring support for the AS function, whilst maintaining appropriate segregation between the two activities.
Main areas of responsibility / key duties:
As a Senior AS Scientist you will have the following main areas of responsibilities and duties:
GMP QC Testing
- You will supervise GMP QC Scientists in their role.
- You will carry out GMP analytical testing for raw materials, in-process and final product & stability test samples.
- Within the shared Analytical Services Department, you will manage the qualification/validation of the assays used in QC, ready for MHRA Licensing and beneficial operation and subsequent inspections.
- You will support Head of Quality in ensure that all QC validations/qualifications are complete and up to date.
- You will work with the wider Analytical Services Team to ensure assays are developed that are ‘fit for purpose’.
- You will control and supervise systems for the management of tests and reference/retain samples for materials and products.
- You will write and approve QC sampling plans and specifications.
- You will lead the GMP technical transfer processes for GMP QC, to be transferred to/from eXmoor Analytical Services or out to the Client.
- You will manage QC materials and supply
- You will manage outsourced QC activities with third parties.
- You will ensure any Quality incidents raised within QC are managed and dealt with appropriately.
- You will perform laboratory investigations and out of specification investigations to GMP standards.
- You will support the site Pharmaceutical Quality System including input into investigations and/or CAPAs.
- You will support both internal and external audits including writing reports, agreeing CAPA and following these up as required.
- You will review and approval of risk assessments and validation documentation as required.
- You will conduct Product Quality Reviews as required.
- You will manage and report on environmental monitoring trends ensuring compliance with GMP standards are being maintained.
QC Analytical Areas
- You will ensure all aspects of the GMP QC laboratory area (including maintenance, operation, qualification, validation, material storage and waste) are managed in compliance with the facility’s stated policies and procedures, and the MIA (IMP) licence.
- You will be responsible for the implementation of SOPs for all activities within the QC laboratory function. These SOPs must comply with GMP and the Facility’s manufacturing licence.
Documentation
- You will ensure principles of Good Documentation Practice are maintained within QC
- You will review and approve QC operational SOPs prior to implementation.
- You will create, review and approve QC GMP SOPs, test methods/report forms and specifications.
- You will quality review and approval of maintenance, calibration and validation activities.
Training
- You will support the training and development of GMP QC staff.
- You will have responsibility for providing training in QC methodology and QC GMP systems
- You will be responsible for maintaining your training folder.
Safety
- 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 comply with laboratory and GMP documentation including Risk Assessments, SOPs, COSHH forms, lab notebooks and records.
Projects
- You will present data to our clients and take part in the technical discussion during project team meetings
- You will support project management with any scope changes when required.
Person Specification:
Essential Qualifications & Experience:
- Minimum BSc level education in a relevant subject area or equivalent experience
- Considerable experience (3 years plus) working within GMP Quality and QC operations, equipment qualification, quality and GMP documentation.
- Experience in leading a small team of scientists in a supervisory role. This includes the ability to lead, develop, motivate, and organise a small team.
- Understanding of Good Manufacturing Practice as applied to small scale biopharmaceutical production for clinical trials.
- Technical expertise in the analytics related ATMPs including but not limited to, HPLC, FACS and PCR.
- Understanding and experience of the following processes:
- PQS systems such as deviations, change management, risk management, OOS, audits/self Inspections and product complaints
- C> analytics related to the assay, purity, identity, safety and potency of drug products.
Desirable Qualifications & Experience:
- In depth understanding and experience in the establishment and management of Pharmaceutical Quality System and QC function.
- In depth understanding and experience of technologies used in the analysis of cell and gene therapy products including FACS, HPLC and PCR
- 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.
- Qualified Person with experience in the certification of ATMP products
Competences Required:
- Organisation, planning and time management
- Commercially aware and able to manage procurement & budgets.
- Oral and written communication skills
- Leadership and team working
- 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).
