Manager, Manufacturing

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at [Register to View] style="font-size: 11.0pt;">https://www.astellas.com/en.

Our Values:

• Be BOLD (Find a Way)
• Care Deeply – for our patients, each other and our work
• #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Astellas Gene Therapies is seeking an experienced Manager, 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. This role typically reports to the Associate Director or Director of Manufacturing. This role will be located in Sanford, NC manufacturing facility.

Primary Responsibilities

• Recruit, hire, and develop a high-performing manufacturing team; oversee training platforms and ensure applicable qualifications are completed as required for entire staff.
• Oversee the drafting, approval, and post execution review of manufacturing generated documentation, including SOPs and batch records while ensuring the highest level of compliance and personnel safety is maintained on the manufacturing floor.
• Partner with Quality Assurance to complete investigations for nonconformances that arise during GMP manufacturing operations; identify and implement effective CAPAs to prevent recurrence; close quality records on time.
• Support regulatory inspection activities for manufacturing areas, personnel, and procedures.
• Identify, lead, and/or support improvement initiatives; initiate and/or own change control records to document implementation of improvements and enhancements.
• Build effective working relationships with both cross-site and cross-functional disciplines, ensuring company goals and process platforms are carried out in an effective and collaborative manner.
• Lead process tech transfer forums as a manufacturing operation representative throughput
• communication of operational capabilities and campaign performance data as well as contributing towards facility modifications when required.
• Assist with the prioritization of projects with greatest benefit to safety, product quality, cost, and/or product throughput.