Associate Director MES Operations
Regeneron Pharmaceuticals
Summary
Regeneron is currently looking for an Associate Director, MES Operations, to direct all aspects of the operation and utilization of the Regeneron Manufacturing Execution System (MES). This role is responsible for ensuring that MES operations fully meet the needs of the business by aligning with Clinical and Commercial Manufacturing leadership and ensuring that associated policies and processes are effectively implemented and maintained.
Job description
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- Provides leadership, vision and management to the MES operations team
- Directs the needs of functional groups and establishes the priorities for MES operations
- Develops strong business relationships with Clinical and Commercial Manufacturing, Quality Assurance and Material Management groups to attain a solid understanding of their goals and objectives to ensure alignment with MES operations
- Develops a strong business relationship with Information Technology to ensure that MES operations goals and objectives are met
- Aligns MES operations team's business practices with Clinical and Commercial Manufacturing objectives to pro-actively anticipate future needs and create solutions to address them
- Responsible for the strategic vision of MES Operations and manages the delivery of objectives
- Conducts requirement and design sessions with users as needed for continuous process improvement
- Reviews company documentation including SOPs, requirements and Manufacturing Batch Records to assess MES impact
- Ensures that MES Recipe authoring, workflows, Electronic Batch Records, etc. are developed and maintained to enable MES operations
- Provides MES operations support for User Acceptance Testing (UAT) for upgrades and other changes to MES
- Provides performance and usage metrics as required
- Collaborates with appropriate training groups to develop and schedule training sessions that best serve the business needs
- Provides MES operations team members with guidance and support to ensure that they have the skills and tools required to consistently support business needs and individual professional goals
- Reviews and approves MES Change Controls
- Ensures GxP compliance
- Responds to audit inquiries
- Provides guidance and coaching to staff to develop technical and management skills for career advancement
This role requires
BA/BS in engineering, biological or physical science, computer science or information technology and 10+ years of experience working with MES or manufacturing systems within a life science manufacturing environment, including previous management experience, or equivalent combination of education and experience
Requirements
- BA/BS in engineering, biological or physical science, computer science or information technology
- 10+ years of experience working with MES or manufacturing systems within a life science manufacturing environment
- Previous management experience
- Equivalent combination of education and experience
Benefits
- Annual Bonuses
- Incentive Plans
- Equity Awards
- Pension Benefits
- Retirement Benefits
- 401(k) Company Match
- Health and Wellness Programs
- Fitness Centers
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Paid Time Off
- Family Support Benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.