As a key member of our team, you will play a vital role in the manufacture of Advanced Therapy Medicinal Products (ATMP).
Main Responsibilities:
* Perform manufacturing and quality control activities according to Good Manufacturing Practice (GMP) guidelines to ensure the production of high-quality ATMP.
* Identify, report, and support health and safety issues and investigations, as well as identify potential health and safety improvements.
* Maintain work areas in an inspection-ready state at all times.
* Drive personal development and seek opportunities to grow and expand additional capabilities.
* Communicate professionally with team members and other stakeholders.
* Collaborate and deliver continuous improvements within the manufacturing area to enhance safety, quality, and flow.
* Evaluate and resolve quality issues and investigations.
* Ensure individual and co-worker work complies with GMP, Data Integrity, and Good Documentation Practice (GDP).
* Complete necessary training in a timely and GMP-compliant manner before task execution.
* Closure of assigned GMP documentation in a timely manner, first-time correct, and in accordance with procedures.
* Sanitize and monitor facility and materials adequately to prevent contamination or cross-contamination.
* Movement and preparation of materials required for bioprocessing and support activities, including management within the Enterprise Resource Planning system.
* Verify materials used in manufacturing are correct, clean, suitable, and readily available for production in accordance with agreed-upon schedules.
* Safe working practices.
* GMP compliance, including Data Integrity.
* Excellent cleanroom behaviors.
* Timely completion of commitments.
* Professional conduct with emphasis on timeliness, teamwork, respect for others, and commitment.
* All training completed prior to undertaking a task, with no overdue training.
* Good understanding of manufacturing processes and GMP guidelines.
* Strong problem-solving skills and analytical thinking.
* Excellent communication and interpersonal skills.
* Able to work effectively in a team environment.
* Adaptable and able to prioritize tasks efficiently.
* Familiarity with cleanroom operations and hygiene protocols.
* Ability to maintain accurate records and documentation.
* A competitive salary and benefits package.
* Ongoing training and professional development opportunities.
* The chance to work in a dynamic and supportive team environment.
* The opportunity to contribute to the production of innovative and life-changing medicines.
This role entails shift work. The rotation pattern is as follows: Early Shift (7:00 – 15:00), Late Shift (15:00 – 23:00). You may be required to temporarily work regular day shifts (08:30 – 16:30) or 12-hour day shifts (07:00 – 19:00). Compensation for the above shift patterns, including night work, will be provided in the form of a monthly Shift Premium.