Job title: QC Scientist
Reporting to: Senior QC Scientist
Department: GMP
No of Direct reports: 0
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 Scientist will perform assays related to drug product manufacturing, critical raw materials testing and, if required, assays in support of process development. 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 of two technical areas (Process/Analytical Development & GMP clinical phase production, including a small fill/finish capability) and all associated QC, both working closely together such that processes developed in the PD/AD area will be transferred at scale to the GMP suites & GMP QC Analytical laboratories.
The QC Scientist will be responsible for the conduct of analytical assays in support of manufacturing and product release whilst also supporting the PD function when required, in performing assays and reporting data to support the development of new processes. The QC scientist should display a pride in maintaining the laboratory function and the quality of their work.
Main areas of responsibility / key duties:
As a QC Scientist you will have the following main areas of responsibilities and duties:
GMP QC Testing:
* Running QC assays and reporting of data by following approved analytical procedures
* Maintaining and calibrating the QC analytical instrument
* Preparation of buffers used in the analytical assays supporting manufacturing
* Preparation of reference standards following approved procedure
* Receipt, labelling and storage of sample
* Qualification of assays and reference standard
* Performing of routine environmental monitoring, liaison with external service providers for routine EM and reporting result
* Immediately reporting any deviations and OOSs that occur within the QC function.
QC Analytical Areas:
* You will support senior QC scientist(s) in maintaining the laboratory area, including stock levels of QC consumables and reagents.
* Ordering of QC consumables and reagents
* Monitoring engineers whilst maintaining analytical instruments
* Support for the maintenance of the manufacturing areas
* Cleaning of the analytical laboratory areas
Documentation:
* You will be responsible for drafting SOPs and QC report forms for the conduct of QC assays.
Training:
* 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 GMP and laboratory documentation including Risk assessments, SOPs, COSHH forms, lab notebooks and records.
Projects:
* You will present data internally in project and larger company meetings.
* You will support project management with any scope changes when required.
Person Specification:
Essential Qualifications & Experience:
* Minimum BSc degree level in relevant subject area.
* Experience (>1 year) of working within a regulated and controlled laboratory environment.
* Experience in analytical procedures such as HPLC, FACS, QPCR (experience in all not an absolute).
* Ability to report data accurately and completely.
* Experience in following approved procedures.
Desirable Qualifications & Experience:
* Understanding of GMP and operating within a QC analytical function.
* Development of analytical methods.
* Writing of analytical procedures.
* Presenting and reporting data to senior members of the eXmoor team.
* Operating within a QMS and experience in reporting deviations and OOSs.
Competences Required:
* Organisation, planning and time management.
* Oral and written communication skills.
* Teamworking.
* 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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