Technical Supervisor (ATMP)

KEY ACCOUNTABILITIES

Technical Delivery

• Provide support to the Head of Technical, Head of Manufacturing and ATMP Manager in the introduction of new projects to Symbiosis.
• Support in being the Technical point of contact for clinical and commercial manufacturing.
• Directly interact with the Team Leaders to ensure that projects are transferred into the facility within agreed timeframes and staff are adequately trained and informed of the process specifics to ensure success of project.
• Support the timely procurement of all materials by directly working with Supply Chain Manager and escalating any issues to ATMP Manager and Head of Technical
• Have full responsibility for generation and technical approval of MTA’s and BMRs in support of the Head of Technical, ATMP Manager and Project Management Team
• Ensure all relevant legislation is adhered to within the Technical department. Eg COSHH, Health and Safety at Work
• Maintain control documentation and relevant Standard Operating Procedures in liaison with the Quality department
• Demonstrate a culture of continuous improvement and work with management to implement process improvements and positive change within the technical transfer process
• Provide training and cleanroom expertise to manufacturing staff and adopt a supervisory role within the cleanroom during operations
• Have direct involvement in any technical transfer projects.
• Identify and escalate problems occurring within the technical processes and ensure that escalation is performed in a timely manner

Compliance & Quality Management

• I ensure that quality standards are achieved and maintained, taking ownership of non-conformances
  and CAPA’s as required and ensure that QMS documents are completed in a timely manner and
  provide wider support to the rest of the business as deemed necessary
• Actively participate in initiatives to increase compliance across the business
• Ensure that the GMP competency-based training and training file are maintained in an inspection
  ready state
• Support the Head of Technical in internal training initiatives as required
• Ensure Quality standards are achieved and maintained in manufacturing areas and maintain a clean
  and safe workplace in accordance with GMP and Health & Safety Guidance

Business Support

• Foster and maintain professional working relationships with clients
• Subject Matter Expert (SME) in designated areas of expertise in audits and inspections as required
• Support the activities of the wider technical team as and when required
• Develop and review systems of work and procedures to ensure the safe and efficient manufacture of
  product and delivery on al manufacturing and business KPI’s.
• Initiate process improvement and continuous improvement projects within the manufacturing department
• Undertake induction and training of all staff in Aseptic Manufacturing Standard Operating Procedures.

Managing Relationships

• Attend, participate and contribute to regular staff and management meetings, as necessary.
• Invest in developing relationships with all staff to fully understand staff’s technical & process support
  needs and develop my colleagues accordingly
• Invest in developing relationships with the management team to ensure we are a high-performing Technical team and Symbiosis’ services meet expectations.
• Act as an ambassador for the company.

Management & Development of Team

• Support the induction, and development of the staff to ensure they are clear about how they contribute to
  Symbiosis and can operate at their best.
• Understand the team’s needs, capabilities and preferred ways of working, and provide them with support
  and feedback.
• Ensure the safety and productivity of the manufacturing team