Description:
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 .
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence 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.astellasgenetherapies.com.
The Role:
The Material Manager will be responsible for managing materials used in gene therapy manufacturing including single-use consumables, raw materials, and packaging materials. The position will own the Single-Use Program, maintain material qualification procedures, and will serve as a key stakeholder in the Material Review Board. The role is also responsible for effective collaboration with several stakeholders including but not limited to: Manufacturing, MSAT, Process Engineering, Process Development, Quality Assurance, Process Sciences, Regulatory, CMC teams, Facilities, Validation, Supply Chain, Quality Control, and various vendors.
Responsibilities:
- Responsible for ensuring all materials used in vial-to-vial manufacturing are appropriately qualified and adhere to single-use policies and procedures; ensures stable supply of materials at the phase appropriate level of quality and grade
- Drive risk assessments as required for materials, suppliers, and manufacturing locations
- Collaborate with supply chain department to create and manage Bill of Materials for processes executed in the Sanford manufacturing facility
- Author, revise, and review SOPs, qualification/validation protocols, reports, and material specifications
- Lead in managing and monitoring of testing activity with various Approved Contract Testing Laboratories
- Ensures sampling, inspection, testing, and release timelines are met; follows well-defined and established procedures and best practices
- Author and approve raw materials sections of multiple Biologic License Application (BLA) and Investigational New Drug (IND) applications
- Define roles, responsibilities, and actions for the Material Review Board meetings
- Support audits and inspections from internal and health authority organizations; support regulatory interactions and submissions
- Own and support material change controls, deviation investigations, root cause analysis, and CAPAs
- Ensure safety of single use components materials for chemical compatibility, sorption, leachable/ extractables, TSE/BSE, biocompatibility and bioburdensterility where needed
- Ensure the safety of raw materials for Melamine, Nitrosamine, BSE/TSE for all materials and bioburden, and endotoxin per intended use
Quantitative Dimensions:
The Material Manager will provide expertise in managing all aspects related to materials used in gene therapy manufacturing, from vial thaw to drug product vial filling, product and non-product contact. The role is expected to manage and lead material discussions, meetings, questions, and troubleshooting efforts. They are responsible for staying up to date on technology advances and recommend new technologies that will enhance processes.
Organizational Context:
The Material Manager will report to the Associate Director, MSAT & Engineering. 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 Therapies and the Astellas organization.