About the Role
The Fill/Finish Associate performs all duties related to the production and support of drug product manufacturing. Works individually and as part of a team to support and perform operations to maintain formulation, filling, assembly, labeling, and cartoning/packing equipment for parenteral biological products. Seeks to understand and develops proficiency in processes or procedures of increasing complexity.
Responsibilities
- Operate highly automated aseptic filling equipment to load drug product into vials, syringes, and cartridges within isolators or other cleanroom environments.
- Assemble filled product into syringes and autoinjectors.
- Run state-of-the-art packaging lines to label and configure product for distribution.
- Monitor production operations using process controls and feedback systems (pneumatics, robotics, manual checks, and PLCs) to ensure throughput, quality, and compliance.
- Perform equipment changeovers, cleaning, handling, and installation of interchangeable parts.
- Maintain clean, safe, and inspection-ready workspaces and equipment.
- Maintain gowning qualification and adhere to aseptic/cleanroom behaviors.
- Perform environmental monitoring and sampling as required.
- Create, follow, and improve SOPs and operating procedures aligned with cGMP and regulatory expectations.
- Ensure compliance during execution and promptly escalate nonconformities.
- Record and review GMP data with ALCOA principles (accurate, legible, attributable, contemporaneous).
- Reconcile product and controlled materials.
- Ensure complete training documentation.
- Utilize electronic systems (e.g., MES/eBR, LIMS, training systems, and Microsoft Office) to support manufacturing operations and documentation.
- Travel domestically and internationally as needed to support production or technology transfer activities.
Requirements
- Full cleanroom attire required, including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents during gowning process including IPA.
- 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.
- Physical requirements include bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation, and ability to lift/push/pull up to 50lbs.
- Background checks may be conducted in accordance with laws to verify identity, right to work, and educational qualifications.
Skills
- Proficiency in processes or procedures of increasing complexity
- Aseptic filling
- Syringe and autoinjector assembly
- Packaging line operation
- Process controls monitoring
- Equipment changeovers
- Equipment cleaning
- Gowning qualification
- Aseptic/cleanroom behaviors
- Environmental monitoring
- SOP creation and improvement
- cGMP compliance
- GMP data recording and review
- ALCOA principles
- Electronic systems utilization (MES/eBR, LIMS, training systems, Microsoft Office)
Location
- Rensselaer, New York, United States
Work Type
- 4 working days (10 hours) shifts
- On-site
Experience Level
- Level determined by qualifications relevant to the role
Education Level
- HS diploma/ GED
- AS, BS or BA in Life Sciences or related field
Salary/Compensations
- Salary Range (hourly) $16.20 - $38.56
Benefits
- Student loan paydown program
- Tuition reimbursement
- Family care benefits
- Inclusion, culture and well-being programs (including physical & mental health)
- 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
- 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.
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.
