Advanced Bioprocessing Scientist in London

Your mission is to perform advanced manufacturing and continuous improvement activities for the production of sterile gene therapy products in line with current Good Manufacturing Practice (cGMP).

Major Activities

• Responsible for driving own development and coaching/training of Bioprocessing Scientists in line with the Training Plan.
• Responsible for performing manufacturing activities in multiple unit operations, following all GMP instructions and good practices to manufacture the required products.
• Responsible for identifying, reporting and investigating issues and coaching others on investigations.
• Responsible for identifying, reporting and where appropriate investigating safety risks and near misses.
• Responsible for identifying, collaborating and delivering continuous improvements within the manufacturing area to improve safety, quality and flow.
• Responsible for operating appropriately within a clean room environment to achieve the required level of low bioburden / aseptic operations.
• Responsible for routine monitoring of the manufacturing facility to ensure that the facility operates in a compliant and safe manner.
• Responsible for performing sanitisation of the manufacturing materials and facility.
• Responsible for ensuring materials used within manufacturing are correct, clean, appropriate and in place ready for manufacture to the agreed schedule.

Key Performance Indicators

• Safe working of self and with others.
• Compliance with GMP requirements including Data Integrity.
• Excellent cleanroom behaviour.
• Timely closure of GMP commitments (issues, BMRs, CAPA, change control).
• Adherence to manufacturing schedule.

Key Job Competencies

• Aseptic processing - Operates to appropriate manufacturing practices to avoid cross contamination and sterile processing.
• Problem Solving - Identifies and resolves problems in a timely manner; able to gather and analyze information; develops alternative solutions; works well in group problem solving situations.
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
• Planning/Organizing - prioritises and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives.
• Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• Oral Communication - speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
• Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures. Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken. Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.

Job Responsibilities

• Responsible for GxP compliance within designated processing areas.
• Accountable for safety of self and team within designated processing areas.

Job Background

• University degree in Science or Engineering.
• Experience in pharmaceutical product manufacture (preference for biologics and aseptic manufacture).
• Good awareness of GMP.
• Demonstrated competency within multiple areas of MeiraGTx bioprocessing and strong performance in managing quality events.

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 initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (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.