CMC Project Specialist

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: [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

The primary purpose of the Chemistry, Manufacturing and Control (CMC) Project Lead is to provide leadership to complex gene therapy programs through several stages of development from early stage to pre-clinical, clinical and through commercial stage. This role will typically report to the Associate Director. 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.

Responsibilities

• Serves as a Chemistry Manufacturing and Control (CMC) strategist and project leader for the gene therapy program portfolio, providing regulatory assessments and developing regulatory strategies under general guidance of the CMC Lead, Associate Director.
• Partners with multiple stakeholders from cross-functional teams in Technical Operations, Research and Regulatory functions, to plan and execute a development strategy that ensures earliest possible pathway to clinic and market, in conjunction with Core Team overall program strategy.
• Drives action plans and lead/co-lead complex projects across the division in support of overall program strategy. Develops and manages plans to achieve division objectives.
• Leads GMP activities with Quality, Regulatory CMC, Technical Development and Research to ensure appropriate program development key deliverables and milestones are achieved.
• Ensures alignment with Core Team stakeholders such as M&D, Global Regulatory, Clinical and Commercial. Escalates issues to member of management team as needed.
• Acts as liaison with members of global Astellas Development and Regulatory Departments as needed to drive programs forward.
• Provides CMC leadership experience and Program and/or Project management oversight.
• Leads the preparation of CMC information for submission to regulatory agencies, generate CMC strategies, assesses risks and develops contingency plans, including major, complex applications.
• Provides biologics drug development expertise preferably in AAV mediated gene therapy field to facilitate work.
• Additional responsibilities may arise as this role develops and adapts to current business needs