We are currently looking to fill a Fill/Finish Specialist. The Fill/Finish Specialist performs all duties related to the development, production, and support of aseptic filling manufacturing processing. Works individually, and as part of a team, to support and perform operations to maintain formulation, filling, assembly, labeling and cartoning/packing equipment for biological products. Proficient in a wide range of processes or procedures of increasing complexity and utilizes expertise to develop the proficiency of Associates across Internal Fill/Finish. Leads projects across cross-functional teams to support operational excellence. Subject matter expert for the Fill/Finish organization with the ability to train others utilizing technical expertise and advanced understanding of drug product manufacturing. Trained and able to present and speak with regulators. Performs advanced troubleshooting of equipment to reduce and prevent downtime. As a Fill/Finish Specialist, a typical day might include the following: + 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: + Interacts with, operates, and performs advanced trouble shooting of highly automated equipment to manufacture drug product and finished goods. Operations include but are not limited to filling drug product into vials or syringes within isolators or other aseptic environments, assembly of filled drug product into syringes and autoinjectors and packaging assembled and labeled drug product into packaging configurations for distribution utilizing and state of the art packaging lines. + Leads projects cross functional in nature applying knowledge from all facets of Internal Fill/Finish + Subject matter expert with the ability to train others. Deep knowledge of core function and ability to connect dots across multiple functions throughout Internal Fill Finish and IOPS. Significant technical acumen to lead significant technical projects/solve technical problems + Monitors and improves production line efficiency through process controls including pneumatics, robotics, manual and PLC feedback loop systems + Cleans, handles, and installs interchangeable parts for various systems and equipment + Implements emergent technologies such as augmented reality to support process innovation + Maintains gowning qualification and adheres to clean room behaviors wherever required + Collaborates to create and maintain operating procedures and manufacturing records to perform routine activities that adhere to regulatory expectations + Reviews and works to resolve exceptions within manufacturing records for timely closure to maintain production schedule and product quality + Ensures working spaces and equipment are clean, safe, and ready for processing activities + Performs environmental sampling using various methods where applicable + Records GMP data that is accurate, legible, attributable, and contemporaneous and completes review on those records + Interprets and collects data from state-of-the-art machinery and identifies actions to drives for continuous improvement + Maintains and ensures proper documentation of all training and is cross trained on multiple operations across Fill and Finish + Ability to navigate production delays with appropriate training level and ensure business continuity + Navigates and utilizes electronic systems to support manufacturing operations + Ensures compliance with applicable procedures while executing activities and forms cross functional teams to address non-conformities during operations. Informs and escalates problems to leadership as needed + Performs reconciliation of product and controlled materials where applicable + Trained and able to present and speak with regulators + Travel (domestic and international) may be required This role might be for you if: + Must be able to stand for extended periods of time and lift, push and pull at least 50lbs. + Knowledge of cGMP and FDA regulated manufacturing environment and familiarity with cGMP filling, assembly or packaging processes. + Knowledge of relevant industry standards, regulations, and or trends + Necessary to have keen attention to detail and demonstrate from previous work experiences. + Able to transfer knowledge from previous experiences or troubleshooting + 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. + Proficiency in Microsoft Office Suite. + Demonstrates strong interpersonal, cross-cultural, communication, negotiation and has a high emotional IQ. + Active participation and engagement in leading peer groups and holding team accountable to internal policies and procedures + Provides guidance to peers through clear written and/or verbal communication to ensure accurate and timely execution of tasks + Exhibits confidence and strong problem-solving skills and demonstrated 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. + Possess a strong and effective communication style among peers and with management team + Deep seeded knowledge on core job function and able to connect the dots across the business leading to the technical acumen necessary to lead and resolve technical problems + Supports the development and maintenance of a diverse and inclusive environment. + Strong resilience and ability to navigate ambiguity + Values and acts with integrity Shift Requirements: Physical + Ability to perform physical requirements for entirety of shift (up to 10 hours): + Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs Gowning and Environment + Full cleanroom attire (Examples may include: including 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 To be considered for the Fill/Finish Specialist you must have a GED/High School diploma and 8 years of relevant GMP work experience or equivalent combination of education or experience. _Level is figured out based on qualifications relevant to the role._ Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler 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. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. **Salary Range (hourly)** $31.92 - $52.12