Visual Inspection Associate Program Manager

Regeneron Pharmaceuticals, Inc (USA); United States; 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, ensuring regulatory compliance and high product quality in fill/finish operations. The role collaborates with Manufacturing Operations, QA, Regulatory, and Process Development to drive continuous improvement.

The ideal candidate has a Bachelor's degree in a scientific or engineering field and 6+ years of manufacturing experience, including

Qualifications

• Bachelor's degree in scientific or engineering discipline with 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.

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

Team management

Regulatory compliance

Quality assurance

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.

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 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

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.

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