Visual Inspection Associate Program Manager

BioSpace; Town of East Greenbush (NY); On-site; USD 92,000 - 151,000; Full time

Job summary

Regeneron is seeking a Visual Inspection Associate Program Manager in Rensselaer, NY to lead the site inspection program and drive quality across liquid and lyophilized products. The role collaborates with Manufacturing Operations, QA, Regulatory, and Process Development to ensure top-tier product quality.

The ideal candidate has a Bachelor's degree in a scientific field and 6+ years in manufacturing with supervisory experience, plus experience in a cGMP environment and a track record of

Qualifications

• Bachelor's degree in scientific or engineering discipline required.
• 6+ years of manufacturing experience, with supervisory responsibilities.
• Experience in a cGMP fill/finish environment preferred.
• Demonstrated leadership in managing technical teams within a regulated setting.

Responsibilities

• Leads the Visual Inspection Technical Services team and Defect Creation Lab.
• Owns the visual inspection program strategy, standards, and defect criteria for liquid and lyophilized injectable products.
• Ensures inspection processes meet USP, EU Annex 1, 21 CFR Part 211, and ICH/PDA guidance.
• Drives KNAPP/test sets and defect libraries for operator and equipment qualification.
• Monitors KPIs and trends to guide data-driven continuous improvement.
• Collaborates with Manufacturing, QA, Regulatory, Process Development, and EHS on inspection processes and quality.
• Evaluates emerging inspection technologies including AI/ML-based detection for program innovation.
• Manages and develops team members while maintaining cGMP and GDP compliance.

Skills

Visual inspection

Regulatory compliance

Leadership

Project management

Education

Bachelor's degree in scientific 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 sites 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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 sites visual inspection program strategy, standards, and defect classification/acceptance criteria for liquid and lyophilized injectable products
• Ensures inspection processes and documentation meet USP , 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: Bachelors 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:

• 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.

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.

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