Advanced Bioprocessing Scientist

Your mission

The main purpose of the Advanced Bioprocessing Scientist 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).

Job Description

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 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 behavour.
• 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.
• 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.

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Job Responsibilities

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

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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.