Fill/Finish Associate (Internal Fill/Finish MFG)

We are currently looking to fill a Fill/Finish Associate. 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 develop proficiency in processes or procedures of increasing complexity. Typical day & responsibilities Produces life‑saving therapeutics for various indications developed from a dynamic internal pipeline. Works with a team that is accountable for production activities ranging from formulation of drug product to packaging of final drug product, which may include the following process‑related responsibilities: Operates highly automated equipment to fill drug product into vials or syringes within isolators or other aseptic environments. Assembles filled drug product into syringes and autoinjectors. Operates state‑of‑the‑art packaging lines to place assembled and labeled drug product into packaging configurations for distribution. Monitors production line for proper operation through process controls including pneumatics, robotics, manual and PLC feedback‑loop systems. Cleans, handles, and installs interchangeable parts for various systems and equipment. Collaborates to create and maintain operating procedures to perform routine activities that adhere to regulatory expectations. Ensures working spaces and equipment are clean, safe, and ready for processing activities. Maintains gowning qualification and adheres to clean room behaviors wherever required. Performs environmental sampling using various methods where applicable. Records GMP data that is accurate, legible, attributable, and contemporaneous and completes review on those records. Maintains and ensures proper documentation of all training. Navigates and utilizes electronic systems to support manufacturing operations. Travel (domestic and international) may be required. Ensures compliance with applicable procedures while executing activities and escalates any non‑conformities during operations. Performs reconciliation of product and controlled materials where applicable. Qualifications Ability to perform basic algebra and geometry. Reading/writing skills. Must be able to stand for extended periods of time and lift, push and pull at least 50 lbs. Knowledge of cGMP and FDA‑regulated manufacturing environment and familiarity with cGMP filling, assembly or packaging processes preferred. Necessary to have keen attention to detail and demonstrate it from previous work experiences. Preferred experience with aseptic technique and operating filling equipment or with assembly or packaging of parenteral products in vials, syringes and cartridges using both manual and automated equipment preferred. Basic understanding of Microsoft Office Suite. Demonstrates strong interpersonal, cross‑cultural, communication, negotiation and has a high emotional IQ. Exhibits confidence and strong problem‑solving skills and demonstrates ingenuity, creativity and resourcefulness. Gains understanding from provided instructions and works towards established goals. Understands and listens to team members and stakeholders’ needs while supporting a positive team environment. Possesses a strong and effective communication style among peers and with management team. Values and acts with integrity. GED/High School diploma and previous work experience. Shift requirements Ability to perform physical requirements for entirety of shift (up to 10 hours): bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50 lbs. Gowning and environment Full cleanroom attire (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA). Ability to remove jewelry, make‑up and nail adornments when wearing cleanroom attire. Salary Range (hourly) : $16.44 - $39.13 Benefits : A comprehensive benefits package including health, dental, vision, life and disability insurance; fitness centers; 401(k) company match; family support benefits; equity awards; annual bonuses; paid time off and paid leaves (e.g., military and parental leave). Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveller community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. #J-18808-Ljbffr Regeneron