Bioprocessing Scientist

Meiragtx; England; On-site; GBP 35,000 - 55,000; Full time

Job summary

MeiraGTx in the United Kingdom is seeking a Bioprocessing Scientist to support GMP-compliant production of sterile gene therapy products. You will perform production processes following SOPs, work in aseptic environments and ensure equipment is calibrated.

You will monitor the GMP facility daily, assist with stock control, and support technology transfer as needed. Strong numeracy and MS Office skills are required.

Qualifications

• BTEC HNC/HND or degree with practical laboratory elements.
• Experience in pharmaceutical product manufacture.
• GMP understanding in a regulated environment.
• Experience with sample preparation and analysis.
• Numerate and capable with data handling.
• Proficiency in MS Office (Word/Excel/PowerPoint).

Responsibilities

• Perform GMP-compliant production following SOPs.
• Use aseptic techniques in a clean room to manufacture sterile products.
• Monitor the GMP facility daily for compliance and safety.
• Carry out routine cleaning and environmental monitoring.
• Assist in stock control, ordering and storage of materials.
• Support technology transfer activities when processes are transferred.
• Recognise and report deviations; plan duties to meet delivery targets.
• Ensure equipment is calibrated and maintained per SOPs.

Skills

Aseptic technique

GMP compliance

Numerate

Data integrity

Education

BTEC/HNC/HND or degree in science

Tools

MS Office

Job description

Your mission

The main purpose of the Bioprocessing Scientist is to support Good Manufacturing Practice (GMP)-compliant activities for the production of sterile gene therapy Products.

Major Activities

• Perform production processes, following SOPs and GMP practices to manufacture required products.
• Proficient in the use of aseptic manufacturing techniques to assure the manufacture of intermediate sterile products.
• Operate to appropriate GMP practices within clean room environment to assure continued compliance within those areas.
• Carrying out the day-to-day monitoring of the GMP facility to ensure that the facility operates in a compliant and safe manner to allow the production of gene therapy products at the required standards.
• Perform routine cleaning of the manufacturing facility.
• Perform the environmental monitoring of the manufacturing facility.
• Ensure that the MeiraGTx manufacturing facility and storage areas are maintained in a fit-for-purpose state.
• Conduct regular stock checks and assist in the maintenance of the stock inventory.
• Assist in stock control including ordering against defined specifications and receipt of materials, appropriate storage of starting biological products, (Quality Control QC) approval and release of materials for use.
• Comply with MeiraGTx procedures including Health and safety and GMP.
• To ensure all equipment used is calibrated/maintained and in line with SOPs.
• Recognize and report procedural problems and deviations.
• Participate in the planning of duties to ensure customers receive products on time and in full.
• Any other duties/projects as are responsible and within the skills and ability of the post holder.
• If required, support technology transfer activities as new processes are transferred into manufacturing.

Key Performance Indicators

• Aseptic technique qualification.
• GMP compliance.
• Contamination free GMP Batch manufacture.
• Data integrity.

Job Background

• Either BTEC HNC/HND or degree in a relevant scientific discipline with practical laboratory elements (or equivalent) or relevant previous experience.
• Experience in pharmaceutical product manufacture (preference for biologics and aseptic manufacture).
• Good understanding of GMP.
• Practical experience of sample preparation and analysis.
• Need to be numerate.
• Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred.

About us

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson's disease program.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our state-of-the‑art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including cGMP required by the MHRA in the UK and the U.S. FDA. The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

MeiraGTx is an equal opportunity employer.