Major Activities

• Responsible for performing manufacturing and improvement activities in accordance with Good Manufacturing Practice to manufacture ATMP.
• Responsible for identifying, reporting and supporting health and safety issues and investigations, and responsible for identifying potential health and safety improvements.
• Responsible for maintaining own work and work area in an inspection-ready state at all times.
• Responsible for driving personal development, seeking opportunities to grow and expand additional capabilities.
• Responsible for communicating professionally, accurately and in a timely manner with team members and other stakeholders.
• Responsible for identifying, collaborating and delivering continuous improvements within the manufacturing area to improve safety, quality and flow.
• Responsible for identifying, reporting and supporting quality issues and investigations.
• Responsible for ensuring that individual and co-worker work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that the necessary training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned is closed in a timely manner, right-first-time and in compliance with MeiraGTx procedures. 
• Responsible for ensuring the facility and materials are sanitised, monitored and controlled adequately to prevent contamination or cross-contamination.
• Responsible for movement and preparation of materials required for bioprocessing and support activities inclusive of their management within the Enterprise Resource Planning system.

Key Performance Indicators

• Safe working of self and with others.
• Compliance with GMP requirements including Data Integrity.
• Excellent cleanroom behavours.
• Timely closure of GMP commitments.
• High standards of professional conduct including timeliness, teamwork, respect for others, and commitment.
• All training completed prior to undertaking a task, with no overdue training.

Key Job Competencies

• Good Documentation Practice  - Operates to appropriate manufacturing practices and procedures to produce and complete documentation of the highest standard.
• Cleanroom behaviours – Operates to a high standard of hygiene and technique within cleanrooms to maintain the required level of cleanliness for ATMP manufacturing
• Motivation - demonstrates persistence and overcomes obstacles; strives for excellence and demonstrates consistent pride in own work. 
• 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 their own actions; follows through on commitments.
• Quality Improvement - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
• 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

• Fluent English language (written and oral)
• Competency and familiarity with basic IT systems (e.g. Microsoft Office, etc.)Previous experience in a GMP manufacturing environment (preferred not mandatory).