Regeneron · 8 hours ago
Drug Product MSAT Engineer- Fill Finish
Rensselaer, NY
Full-time
Onsite
New Grad, Entry, Mid, Senior Level
$62K/yr - $129K/yr
0+ years expRegeneron is currently looking for a DP MSAT Engineer to join their Process Science Drug Product Engineering department. This role focuses on lifecycle management and fill finish operations, supporting equipment selection and process validation activities while providing technical support for cGMP drug product manufacturing operations.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution
Acts as the technical lead, with the support of cross-functional teams, for technology transfer of the drug product manufacturing processes to manufacturing facilities
Tracks and reports project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc
Reviews and approves cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities
Assists with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations
Trends process performance and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations
Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities
Supports development of sampling plans for GMP batches related to lot release, stability and characterization
Assists in equipment selection, qualification and start up activities
Works with Manufacturing to ensure robust procedures are utilized for operation of equipment
Partners with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery
Maintains required training status on Regeneron specific work instructions and SOPs
Travels to contract manufacturers or business partners, as required, up to 25%
Qualification
Required
Willing and able to work Monday-Friday, 8am-4:30pm
Willing to travel up to 25%
BS/BA in engineering
Previous experience working in GMP environment
0-2 years of relevant experience for Associate DP MSAT Engineer
2+ years of relevant experience for DP MSAT Engineer
5+ years of relevant experience for Sr. DP MSAT Engineer
Preferred
Experience interacting with Contract Manufacturing Organizations
Demonstrate technical knowledge in drug product manufacturing, product development and validation
Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills required
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
Pharmaceutical Technology
2025-12-29
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