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Senior Manager, Manufacturing Operations
2 months ago
Astellas Pharmaceuticals is seeking a highly skilled and experienced Senior Manager, Manufacturing to join our team at the Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Key Responsibilities- Oversee the production of cellular products, including MCB/WCB cell banking, toxicology lots, engineering, clinical, process qualification (PPQ) batches, and commercialization.
- Implement cell manufacturing operations in compliance with cGMP regulations, working collaboratively with cross-functional stakeholders to ensure timely and compliant production.
- Recruit, hire, and develop a high-performing manufacturing team, overseeing training platforms and ensuring applicable qualifications are completed as required.
- Partner with Quality Assurance to complete investigations for nonconformances, identify and implement effective CAPAs, and close quality records on time.
- Support regulatory inspection activities, identify and lead improvement initiatives, and own change control records to document implementation of improvements and enhancements.
- BS/BA in Biological sciences or equivalent with 6+ years of applicable industry experience, or Associate's Degree in Science with 8+ years of industry experience, or H.S. diploma with 10+ years direct industry experience.
- 4+ years of experience leading teams in a GMP manufacturing environment, with expertise in aseptic processing and cell culture.
- Proven effective problem-solving skills, strong safety focus, and ability to promote safety consciousness within the manufacturing organization.
- Outstanding communication skills, with ability to work independently and closely within a team.
- Medical, Dental, and Vision Insurance
- Generous Paid Time Off options, including Vacation, Sick time, and national holidays
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Referral bonus program
