Team Lead BioPharma Manufacturing Operations SFD-TC

Team Lead BioPharma Manufacturing Operations SFD-TC

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

The Supervisor Manufacturing will be a key contributor to manufacturing readiness and future operational output. The role will initially support commissioning and start-up activities as the GMP facility is built. This includes equipment testing, layout planning, SOP and other documentation generation, as well as the recruitment and training of staff. After the startup of manufacturing operations are complete, the role will be responsible for executing a combination of engineering, clinical, and process qualification (PPQ) batches with supporting staff. This role, as part of the Manufacturing leadership team, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.

Role and Responsibilities

• Ensure seamless transfer of information and responsibilities across shifts and between processing areas
• Hire, train, supervise, and develop subordinate Manufacturing Associates while ensuring all parties are compliant with required GMP training and related documentation
• Support drafting and/or approval of manufacturing documentation, including SOPs and batch records
• Coordinate with other departments to schedule work and other activities that impact manufacturing site milestones and/or process schedules
• Coordinate with Supply Chain and the Warehouse to ensure materials and other consumables are ordered and received in time for both commissioning and production needs
• Support and/or own quality investigations, CAPAs, and other compliance issues, ensuring that process improvement ideas and/or CAPA's are implemented in a timely manner.
• Support regulatory inspection activities for manufacturing areas, personnel, and procedures
• Attend safety meetings, ensure that staff adheres to all safety procedures as defined, and maintain a safe work environment within manufacturing owned areas
• Review all executed batch records and other documentation generated from the Manufacturing floor and ensure compliance with all approved procedures and cGMP requirements
• Build effective working relationships with cross-functional disciplines, ensuring company goals, process investigations, and improvement initiatives are carried out in an effective and collaborative manner