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Senior Supervisor, Downstream Manufacturing (5000859744010)





Sanford, North Carolina, United States

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies Therapeutics

Astellas Gene Therapies Therapeutics, an Astellas company, is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.Astellas Gene [Register to View]

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]

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

Reporting to the Associate Director of Manufacturing, this leadership role will be a key contributor to manufacturing readiness and future operational output of the Sanford, North Carolina Gene Therapy manufacturing facility. The Senior Supervisor Manufacturing role will initially ongoing commissioning and validation activities as the site works towards GMP production readiness in 2023. This includes equipment testing, guidance documentation generation, policy oversite, development of staff, as well as engineering batch execution support for downstream operations. Once all validation and engineering run activities are complete, this role, as part of the Manufacturing leadership team, will support the production of clinical and commercial products to the highest standards of cGMP manufacturing.

Primary Responsibilities

  • Lead tech transfer discussions with the intent to define scale up process specifications
  • Coordinate engineering and shakedown run execution for downstream operations
  • Ensure seamless transfer of information and responsibilities across shifts and between processing areas
  • Hire, train, supervise, and develop subordinate Manufacturing Associates
  • Monitor staff to ensure compliance 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
  • 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
  • Support regulatory inspection activities for manufacturing areas, personnel, and procedures
  • Attend safety meetings and follow all safety procedures as defined, including maintaining a safe work environment for both self and colleagues
  • Communicate process improvement ideas identified during start up and/or commercial operations as well as support the implementation of approved changes
  • Review all executed batch records and other documentation generated from the Manufacturing floor and ensure compliance with all approved procedures and cGMP requirements
  • Other duties as assigned