Visual Inspection Associate Program Manager

Regeneron Pharmaceuticals, Inc; Town of North Greenbush (NY); On-site; USD 92,000 - 151,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY is seeking a Visual Inspection Associate Program Manager to lead the site’s visual inspection program across liquid and lyophilized injectable products.

You will drive inspection standards, defect classification, and regulatory alignment (USP, EU Annex 1, 21 CFR Part 211) while collaborating with Manufacturing Operations, QA, Regulatory, and Process Development to ensure every dose meets high quality standards.

Qualifications

• Bachelor’s degree in scientific or engineering discipline or related field required.
• 6+ years of manufacturing experience with prior supervisory experience or equivalent.
• Experience in a cGMP fill/finish environment with exposure to visual inspection program elements and regulatory requirements.

Responsibilities

• Leads the Visual Inspection Technical Services team and Defect Creation Lab, building a culture of quality and continuous improvement.
• Owns the site’s visual inspection program strategy, standards, and defect classification/acceptance criteria for liquid and lyophilized injectable products.
• Ensures inspection processes and documentation meet USP <1790>, EU Annex 1, 21 CFR Part 211, and applicable ICH/PDA guidance.
• Drives development of KNAPP/test sets and defect libraries used for operator and equipment qualification.
• Monitors and trends program KPIs, such as defect detection and false reject rates, to guide data-driven continuous improvement.
• Partners cross-functionally with Manufacturing, QA, Regulatory, Process Development, and EHS on inspection processes, equipment, and product quality.
• Evaluates emerging inspection technologies, including automated and AI/ML-based detection, to drive program innovation.
• Manages, coaches, and develops team members while maintaining cGMP and GDP compliance across the program.

Skills

Leadership

Cross-functional collaboration

Regulatory compliance

Quality systems

Education

Bachelor's degree in scientific or engineering discipline

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 Visual Inspection Associate Program Manager to join our technical team, supporting our clinical and commercial fill/finish operations. In this role, you will lead the site’s visual inspection program - from inspection standards and regulatory compliance to equipment performance and technology innovation - while collaborating with Manufacturing Operations, Quality Assurance, Regulatory, and Process Development to ensure every dose meets the highest quality standards.

When & where:

• Location: Rensselaer, NY

• Work model: On-site

Discover your role:

• Leads the Visual Inspection Technical Services team and Defect Creation Lab, building a culture of quality and continuous improvement

• Owns the site’s visual inspection program strategy, standards, and defect classification/acceptance criteria for liquid and lyophilized injectable products

• Ensures inspection processes and documentation meet USP <1790>, EU Annex 1, 21 CFR Part 211, and applicable ICH/PDA guidance

• Drives development of KNAPP/test sets and defect libraries used for operator and equipment qualification

• Monitors and trends program KPIs, such as defect detection and false reject rates, to guide data-driven continuous improvement

• Partners cross-functionally with Manufacturing, QA, Regulatory, Process Development, and EHS on inspection processes, equipment, and product quality

• Evaluates emerging inspection technologies, including automated and AI/ML-based detection, to drive program innovation

• Manages, coaches, and develops team members while maintaining cGMP and GDP compliance across the program

This role requires:

• Associate Manager Level: Bachelor’s degree in scientific or engineering discipline or related field and 6+ years of manufacturing experience, including prior supervisory experience or equivalent combination of education and experience

• Experience in a cGMP fill/finish environment with exposure to visual inspection program elements

• Demonstrated leadership experience managing technical teams within a regulated manufacturing environment

Preferred qualifications:

• undefined

• Demonstrated ownership of visual inspection program elements and applicable regulatory requirements

• Experience evaluating or implementing automated and AI/ML-based inspection technologies

Does this sound like you? 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.

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)

$92,200.00 - $150,600.00