Astellas Pharma Director of Cell Manufacturing in Marlborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma 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.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
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 Marlborough, Massachusetts.
The Director of Cell Manufacturing for Regenerative Medicine is responsible for overseeing management of all areas of production to produce in-house and in-licensed products, and direct activities to ensure products are produced on schedule, and within quality standards and cost objectives. This individual will assure implementation of cell manufacturing operations for the cell therapy and regenerative medicine business by working in collaboration with other stakeholders, cross functionally.
Essential Job Responsibilities:
- Assists company officers and senior staff members in long and short-range planning for programs and objectives
- Develops the production plan and establishes procedures for maintaining high standards of production operations to ensure products conform to established customer, regulatory and company quality standards.
- Achieves optimum employee levels with least amount of overhead and raw material costs to meet annual budgetary plan.
- Is a key contributor in the development of production policies and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation.
- Directs and monitors department managers to accomplish goals of the production plan, consistent with established production and safety procedures. Acts as liaison between department management/subordinate levels, as well as executive/department manager levels to inform personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results.
- Maintains a solid knowledge base of regulatory requirements for biopharmaceutical processing and cGMPs.
- Ensures production operations are consistent with GMP certificates for the manufacturing facility issued from regulatory and local authorities.
- Recruit and hire employees for production of CTMs/initial commercial products.
- Is a key participant in technical transfers, working closely with internal RM process/analysis development function to assure scale up to clinical readiness in RM manufacturing with required level of GMP and
- Is a key participant in manufacturing process transfers of in-licensed products from licensing company, academia and/or government organization to AIRM.
- Support preparation of CTD documentation and IND/NDA submission for RM products in collaboration with relevant functions.
- Drive employee development, coaching and cross-functional skill capabilities through implementation and cross training.
- Interviewing, hiring, and training of new employees.
- Maintain employee safety by creating a safe working environment while making sure employees are following Astellas safety rules and procedures.
- Bachelor's degree in Biological Science or Biochemical / Chemical Engineering with 15 years relevant biopharmaceutical industrial experience in production. Must have extensive experience in production and budgetary processes. Expertise in regulatory requirements and related subjects is essential.
- Knowledge of cleanroom operation requirements
- Experienced in regulatory regulations (FDA, EMA, ISO) and providing direction and support of operational methods and systems.
- Lean-six sigma manufacturing experience and/or certification preferred.
- Strong background in capital portfolio forecasting, planning, and management.
- Demonstrated ability to build sustainable organizations and to hire, develop, motivate, and retain talent.
- Ability to interact with customers internal and external to Astellas.
- Proven organization and coordination skills. Ability to manage multiple projects in a dynamic situation while maintaining the ability to troubleshoot and "think outside the box."
- Successful collaboration on multidisciplinary teams; established track record for cross-functional leadership and facilitation.
- Operations management experience in regenerative medicine platforms
- Knowledge of US and EU aseptic processing regulations as they apply to cell therapy and regenerative medicine
- Strong understanding of contamination control and cGMP requirements for facility design and operation.
- Strong interpersonal, supervisory, oral and written communication skills with the ability to create a high level of teamwork and team/individual accomplishment.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Manufacturing & Operations