Regeneron · 14 hours ago
Associate Manager, Process Validation Oversight
Rensselaer, NY
Full-time
Onsite
Mid, Senior Level
$91K/yr - $173K/yr
6+ years expRegeneron is hiring a Manager, Process Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance.
BiotechnologyPharmaceuticalBiopharma
Responsibilities
Ensuring alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing
Collaborate closely with internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies
Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies
Reviewing and approving process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations
Overseeing all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans
Conduct one-on-one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team
Qualification
Required
Bachelor's degree in Engineering, Chemistry, or Life Sciences degree
6+ years of experience for Associate Manager level
7+ years of experience for Manager level
Hands-on validation experience in a GMP-regulated environment
Deep understanding and expertise in Process Validation
Experience in presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies
Experience in reviewing and approving process validation documents, procedures, and protocols
Experience in overseeing QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans
Experience in conducting one-on-one discussions with team members to review performance feedback and set development goals
Preferred
Enjoy building strong, collaborative relationships across global internal teams
Have a continuous improvement mindset
Are an experienced leader who inspires and guides a multi-tiered team
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-02-13
2026-02-12
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