Associate Director, Site Automation OT Equipment
Regeneron Pharmaceuticals
Summary
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Site Automation to join our Operation Technology Small Equipment, supporting either Red Mill (Bulk Manufacturing) or Temple Lane (Internal Fill Finish) Site. This role is providing technical and automation leadership across manufacturing, testing laboratories, and facilities operations. In this role, you will supervise a team and drive accountability across cGMP automation quality systems, software change control, corrective actions, and equipment procurement and qualification — while collaborating with Manufacturing, Quality Control, Engineering, and vendor partners.
Job description
When & where
- Location: Menands, New York
- Work model/flexibility: Monday - Friday 8am - 4:30pm, onsite
- Travel percentage: 5-10% to US & International travel
Discover your role
- Lead the automation team by setting clear expectations and modeling compliance; ensure adherence to all departmental policies and procedures
- Oversee the cGMP software administration program and automated system periodic evaluation program; ensure SOPs and Software Lifecycle Documentation remain aligned with current regulatory standards and guidelines
- Oversee investigation support for manufacturing deviations, lab testing anomalies, and issues related to automation, software, and hardware
- Lead projects related to corrective action and equipment performance improvement; ensure timely completion of all departmental projects, work orders, and quality management items
- Maintain budget forecast and compliance for the direct team; provide headcount forecasts for department growth to senior management
- Support vendor relationships and ensure compliance with approved suppliers; oversee equipment procurement, commissioning, and equipment and software qualification activities
This role requires
- BS/BA in Science, Engineering, or Software Programming, or equivalent years of direct experience with automated control systems or equipment in lieu of degree
- MBA, MS or advanced degree preferred
- 10+ years of experience with automated equipment in the pharmaceutical or biopharmaceutical industry or related regulated industry, including at least 5 year of direct experience in the design, installation, maintenance, and/or troubleshooting of automated control systems
- Demonstrated experience leading or managing automation teams in a cGMP regulated environment
- Strong working knowledge of cGMP quality systems, software change control processes, and regulatory standards applicable to automated systems
- Experience with vendor management and approved supplier compliance programs preferred
Requirements
- BS/BA in Science, Engineering, or Software Programming, or equivalent years of direct experience with automated control systems or equipment in lieu of degree
- MBA, MS or advanced degree preferred
- 10+ years of experience with automated equipment in the pharmaceutical or biopharmaceutical industry or related regulated industry, including at least 5 year of direct experience in the design, installation, maintenance, and/or troubleshooting of automated control systems
- Demonstrated experience leading or managing automation teams in a cGMP regulated environment
- Strong working knowledge of cGMP quality systems, software change control processes, and regulatory standards applicable to automated systems
- Experience with vendor management and approved supplier compliance programs preferred
Benefits
- Annual Bonuses
- Incentive Plans
- Equity Awards
- Pension Or 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.