Jobs / United States / Regeneron Pharmaceuticals INC
Staff External Manufacturing Specialist (Drug Product)
Regeneron Pharmaceuticals INC · 🇺🇸 RENSS - TECH VALLEY
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 290 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 40 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Regeneron Pharmaceuticals INC paid sponsored hires in similar roles7 certified filings for “Sr Mgr Product Management” (Computer and Information Systems Managers) in NY: $188k–$246k, median $201k. Most were filed at wage level II (71%) — 2 lottery entries, ≈31% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
Or apply yourself on the official page →
Sponsor Radar — Regeneron Pharmaceuticals INC
The US Department of Labor certified 290 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 40 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Regeneron Pharmaceuticals INC →
About the role
Build our future together: We are currently looking to fill a Staff External Manufacturing Specialist as the technical and operational authority for clinical contract drug product (DP) filling operations at CMO and business partner sites. Owns the tech transfer process end-to-end, drives active batch management from pre-production through lot disposition, and is a key GMP decision-maker. Provides technical mentorship and leadership to mid-level specialists, and collaborates with management on compliance strategy and CMO performance in the clinical operations space. When & where: • Rensselaer, NY • Monday-Friday Discover your role: Drug Product Filling – Technical Expertise • Apply deep technical knowledge of aseptic filling unit operations: sterile filtration (bioburden reduction and sterilizing-grade filters), filling (time-pressure, peristaltic, rotary piston), stoppering, capping, and lyophilization cycle development and scale-up. • Interpret environmental monitoring (EM) data, airborne particulate results, and media fill (APS) outcomes; assess implications for batch disposition and process adequacy. • Partner with DP MSAT to evaluate and apply lessons learned across the network as it relates to CCI, APS, filling operations, CMO assessments, etc. • Assess cleanroom design and equipment suitability (ISO 5/Grade A filling zones, Grade B/C support areas) relative to product contamination control requirements. • Support extractables and leachables (E&L) risk assessments for product-contact materials and container closure system selection. Technical Transfer: • Own and lead end-to-end operations of tech transfer to CMO filling sites, gap assessments, risk evaluations and assessments, facility/equipment readiness, engineering run execution. • Approve Technical requirements document (TRD), Master Batch Records (MBR), validation reports, summary reports, etc • Oversee tech transfer, qualification, and validation of filling lines and critical equipment: isolator/RABS, vial/syringe filling systems, lyophilizers, and component prep (depyrogenation tunnels, washers, autoclave). • Coordinates/oversees DP manufacturing at CMO as dictated by project tech transfer and clinical operations. • Liaises between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing and contract manufacturers or business partners. Technical Mentorship & Leadership • Serve as the primary technical resource for mid-level EM Specialists; provide hands-on guidance on aseptic filling operations, batch record review, deviation management, and CMO oversight. • Coach Specialists on interpreting in-process data, applying GMP regulations to real-world filling scenarios, and escalating issues appropriately. • Lead sub-teams on continuous improvement initiatives, filling technology upgrades, and CMO performance management. • Collaborate with management to communicate CMO operational status, proactively, surface risks, and shape external manufacturing strategy. Active Batch Management: • Serve as Regeneron’s primary technical contact for all active clinical batches at CMO sites — track filling status, in-process results, and lot disposition milestones in real time. • Monitor in-process data: fill weight/volume checks, filter integrity test results, visual/automated inspection outcomes, and lyophilization cycle data. • Lead deviation investigations and drive CAPA closure for events occurring during or after filling operations; assess impact on batch and filing. • Track cycle times, yield trends, and reject rates across batches; analyze data for process drift and drive continuous improvement actions with the CMO. • Lead s