Supervisor, Biopharma Manufacturing Operations at Astellas in Westborough, Massachusetts

Job Description:

Supervisor, Biopharma Manufacturing Operations

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Team Lead, Biopharma Manufacturing Operations MA-TC opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

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.

Essential Job 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.

Quantitative Dimensions:

The Supervisor Manufacturing is a key contributor to the readiness and future operational output of manufacturing. The person is responsible for the hiring, recruitment, training of staff and building a diverse and technically strong team. The role will be accountable for executing a combination of engineering, clinical, and process qualification (PPQ) batches.

Organizational Context:

The Supervisor, Manufacturing, will typically report to the Manager, Sr Manager, or Associate Director, Manufacturing. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene and Cell Therapies and the Astellas organization.