Senior Manager, GMP OT Applications
About The Position
Regeneron is seeking a Senior Manager to lead the group responsible for configuring and installing biopharmaceutical process and QC laboratory equipment within its IOPS Manufacturing Automation and Engineering team. The position manages through direct reports and drives automation projects, regulatory compliance, and technical development across manufacturing and laboratory operations. The role is based onsite in Menands, New York, Monday through Friday, 8:00 a.m. to 4:30 p.m. The Senior Manager oversees configuration, installation, and ongoing support of biopharmaceutical process and QC laboratory equipment; coordinates automation support workflows and priorities; serves as a subject matter expert for regulatory inspections and internal investigations; and manages automation projects involving process equipment and laboratory software. The role also supports equipment configuration and qualification, develops procedures and methods for automation work, and ensures the integrity of data generated during drug-product manufacturing and testing. The position advises Manufacturing, QC, and Maintenance, maintains a safe and compliant workplace, and coaches personnel while engaging cross-functional leaders, senior management, and regulatory agencies. Regeneron describes itself as a science-driven organization developing medicines for serious diseases and emphasizes an inclusive workplace and equal opportunity employment. The company offers a competitive total rewards package that may include annual bonuses or other incentives, equity awards, retirement benefits, a 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits, depending on country and role.
Requirements
- Bachelor of Science or Bachelor of Arts degree in Science, Engineering, or Software Programming.
- For the Senior Manager level: 8 or more years of experience and 5 or more years of supervisory experience.
- Current knowledge of cGMP biotechnology and pharmaceutical operations, regulatory and quality policies, procedures, and documentation methods.
- Strong knowledge of the Software Design Lifecycle and Quality Risk Management.
Nice To Haves
- Proven project management capabilities.
- Equivalent combinations of education and experience may be considered; level will be determined based on qualifications.
Responsibilities
- Manage the Automation group through direct reports, ensuring training, development, and compliance of direct reports and subordinate staff across automation functions.
- Oversee configuration, installation, and ongoing support of biopharmaceutical process and QC laboratory equipment.
- Coordinate workflow within automation support groups, set priorities, and vet requests for automation services.
- Serve as a subject matter expert during regulatory inspections and internal investigations.
- Support regulatory compliance through audit participation and quality systems development.
- Manage automation projects related to process equipment and laboratory software.
- Support the Validation Department by providing technical personnel for equipment configuration and qualification.
- Develop procedures and methods for executing automation projects and support activities.
- Ensure data integrity for data generated during manufacturing and testing of drug product.
- Support Manufacturing, QC, and Maintenance as a technical advisor.
- Maintain a safe and compliant working environment by enforcing procedures, policies, and regulations.
- Coach and develop personnel, influence cross-functional leaders on automation solutions, and present to senior management and regulatory agencies as needed.
Benefits
- Annual bonuses or other incentive plans may be offered, depending on country and role.
- Equity awards may be offered, depending on country and role.
- Pension or retirement benefits may be offered, depending on country and role.
- 401(k) company match may be offered, depending on country and role.
- Health and wellness programs may be offered, depending on country and role.
- Fitness centers may be offered, depending on country and role.
- Insurance benefits, including medical, dental, vision, life, and disability, may be offered, depending on country and role.
- Paid time off may be offered, depending on country and role.
- Family support benefits may be offered, depending on country and role.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
