Senior Manager, GMP OT Applications

Regeneron Pharmaceuticals, Inc.; New York (NY); On-site; USD 121,000 - 231,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager to lead the IOPS Manufacturing Automation and Engineering team in Menands, NY. You will oversee automation projects, ensure regulatory compliance, and develop staff across manufacturing and laboratory operations.

The role requires strong SDLC and Quality Risk Management knowledge, plus several years of supervisory experience, and a deep understanding of cGMP biotech operations. On-site with a focus on safety and collaboration.

Qualifications

• 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.
• 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; project management capabilities preferred.

Responsibilities

• Manage the Automation group through direct reports, ensuring training, development, and compliance of staff.
• Oversee configuration, installation, and support of biopharmaceutical process and QC lab equipment; coordinate workflows.
• Serve as SME during regulatory inspections and investigations; support compliance through audits and quality systems development.
• Lead automation projects related to process equipment and laboratory software; provide technical personnel for equipment configuration and qualification.
• Develop procedures for executing automation projects; ensure data integrity for manufacturing and testing data.
• Advise Manufacturing, QC, and Maintenance as a technical resource; enforce safety and regulatory requirements.
• Coach and develop personnel; present to senior management and regulatory agencies as needed.

Skills

Leadership

Project management

Regulatory compliance

Quality systems

Education

Bachelor's degree in Science, Engineering, or Software Programming

Job description

Team: Industrial Operations & Product Supply

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

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

We are committed to building a workplace with an inclusive culture. 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. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. 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, and 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. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$121,100.00 - $231,000.00

Similar roles

Principal Project Manager - Engineering

• Team: Industrial Operations & Product Supply
• Location: Troy, United States of America

Senior Instrument Engineer

• Team: Industrial Operations & Product Supply
• Location: Troy, United States of America

What people ask before they join

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Curious what that looks like step by step? Check out How We Hire .

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

Showing slide 1 of 4 (group 1 of 2)

Our hiring process

From application to your first day — here's how it works.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY

See something you like? Submit your application for the role that fits your background and goals.

3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

Be part of what’s next in science

Hear about new opportunities and stories across our teams.