Major Activities

• Responsible for driving own development and coaching/training of Bioprocessing Scientists in line with the Training Plan.
• 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 comply with MeiraGTx procedures including Health and safety and GMP.
• 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 operate appropriately within clean room environment to achieve 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 - prioritizes 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.

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.