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About the Role

Regeneron is seeking a Manufacturing Process Specialist (Associate through Senior level) to join our IOPS team. This role provides technical support across manufacturing processes, plays a key role in implementing and transferring production programs, resolves process challenges, supports manufacturing personnel, and drives continuous improvement. You will collaborate with various teams to make a meaningful difference to patients worldwide.

Responsibilities

Liaise with process science and technology transfer teams on the transfer and startup of manufacturing processes.
Serve as a key technical contributor to manufacturing records, batch sheets, and procedures.
Provide technical input to resolve process problems on and off the production floor.
Support manufacturing personnel in building technical knowledge of critical process steps.
Write and review SOPs and other controlled documents.
Modify process method files through the quality system in alignment with change control requirements.
Support CAPA implementation for process-related improvements.
Contribute to investigations into process variances in accordance with site procedures.
Partner cross-functionally with Maintenance, Process Sciences, Engineering, Facilities, Process Development, Regulatory, Quality Assurance, and Quality Control to resolve process issues and implement improvements.
Support Right First Time (RFT) programs on the floor.
Implement continuous improvement initiatives across manufacturing operations.
Represent Manufacturing during regulatory and client audits.
Uphold the highest safety standards and support safety improvements requiring technical input.

Requirements

Experience in a cGMP manufacturing environment with familiarity with drug substance or drug product manufacturing processes preferred.
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire.
Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment.

Skills

cGMP manufacturing
Drug substance manufacturing
Drug product manufacturing
Process Sciences
Technology Transfer
Manufacturing Records
Batch Sheets
SOPs
Change Control
CAPA
Process Improvement
Regulatory Audits
Client Audits
Safety Standards

Location

East Greenbush, New York, United States

Work Type

Onsite
Full-time

Experience Level

Associate Specialist: 0–2 years of relevant cGMP manufacturing, engineering, or scientific experience
Specialist: 2+ years of relevant cGMP manufacturing, engineering, or scientific experience
Senior Specialist: 5+ years of relevant cGMP manufacturing, engineering, or scientific experience

Education Level

BS in Life Sciences or a related field
May consider equivalent combination of education and experience.

Salary/Compensations

$62,355.00 - $128,700.00

Benefits

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
Family support benefits

About the Company

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
We are committed to building a workplace with an inclusive culture.
Regeneron offers a competitive and comprehensive total rewards package.

Equal Opportunity

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.