Senior Manager, GMP OT Applications

Regeneron Pharmaceuticals, Inc.; Village of Menands (NY); On-site; USD 121,000 - 231,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager to lead the IOPS Manufacturing Automation and Engineering team, overseeing the configuration and installation of biopharmaceutical process and QC laboratory equipment.

You will manage through direct reports, driving automation projects, regulatory compliance, and the technical development of your team across manufacturing and laboratory operations.

Qualifications

• BS/BA in Science, Engineering, or Software Programming.
• Strong knowledge of cGMP biotech and pharma operations.
• Experience leading automation projects and cross-functional teams.

Responsibilities

• Manage the Automation group through direct reports, ensuring training, development, and compliance across all automation functions.
• Oversee configuration, installation, and ongoing support of biopharmaceutical process and QC laboratory equipment; coordinate workflow within automation support groups.
• Serve as 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 with equipment configuration and qualification.
• Develop procedures and methods for executing automation projects; ensure data integrity during manufacturing and testing of drug product.
• Coach and develop personnel; present to senior management and regulatory agencies as needed.

Skills

Leadership

Project management

Regulatory compliance

CGMP knowledge

Data integrity

Cross-functional collaboration

Education

BS/BA in Science, Engineering, or Software Programming

Tools

Automation equipment configuration

Regulatory inspections support

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our IOPS Manufacturing Automation and Engineering team, overseeing the group responsible for the configuration and installation of biopharmaceutical process and QC laboratory equipment. In this role, you will manage through direct reports, while driving automation projects, regulatory compliance, and the technical development of your team across manufacturing and laboratory operations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Menands, New York

Work model: Monday - Friday 8am - 4:30pm, onsite

Discover your role:

• Manage the Automation group through direct reports, ensuring training, development, and compliance of direct reports and subordinate staff across all automation functions
• Oversee configuration, installation, and ongoing support of biopharmaceutical process and QC laboratory equipment; coordinate workflow within automation support groups, setting priorities and vetting requests for automation services
• Serve as 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 is maintained 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

This role requires:

• BS/BA in Science, Engineering, or Software Programming
• Manager: 7+ years of experience and 4+ years of supervisory experience
• Senior Manager: 8+ years of experience and 5+ years of supervisory experience
• May consider equivalent combination of education and experience; level determined based on qualifications
• Current knowledge of cGMP biotech and pharma operations, regulatory and quality policies, procedures, and documentation methods
• Strong knowledge of Software Design Lifecycle and Quality Risk Management; proven project management capabilities preferred

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Please be advised that at Regeneron, we believe we do our best work when we are together.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate.

Salary Range (annually) $121,100.00 - $231,000.00