Assoc Biotech Production Specialist

Job title: Assoc Biotech Production Specialist

Company: Regeneron Pharmaceuticals

Job description: Summary: Performs all tasks necessary for dispensing, preparation, formulation, and aseptic filling manufacturing processes as well as internal labeling packaging and assembly processes. Works individually and as part of a team to operate and maintain highly automated, isolated, filling equipment, assembly and packaging lines. Seeks to understand and develops proficiency in a wide range of processes or procedures of increasing complexity. Applies experience and skills to provide recommendations and solutions, as well as trains and provides guidance to other colleagues.Essential Duties and Responsibilities include, but are not limited to, the following:Operates and monitors a mix of manual and state of the art filling line with isolator technology, as well as formulation and preparation equipment, according to applicable procedures based on trainingOperates and monitors a mix of manual and state of the art, fully automated Assembly, Packaging and Labeling lines according to applicable procedures based on training.Operates fully integrated Track and Trace systems on Packaging linesPerforms line clearance and cleaning activities of preparation, formulation, filling line, assembly and packaging rooms and equipmentPerforms and/or assists with various QC environmental monitoring and product samplingCompletes and reviews batch records and logbooks in accordance with cGMP standards and compliant with written procedureEstablishing new procedures and processes required for cGMP productionCreates, revises and reviews controlled documentsExecutes batch records within the electronic record system (MES)Completes training and follows appropriate gowning requirements for cleanroom processingEnsures all tasks are performed in a manner consistent with cGMP SOP’s and safety standardsCoordinates to ensure process areas are stocked with essential equipment and componentsCoordinates with facilities team to ensures equipment and process operational readinessReconciles components and product according to SOP and Batch Record requirementsParticipates in equipment start-up, commissioning, and validation activitiesPerforms troubleshooting in case of equipment/systems failureGathers, trends, and analyzes process generated dataSupport investigations associated with process area unit activitiesMaintains and ensures proper documentation of all trainingResponsible for training of new employeesAssists/contributes in all areas of filling manufacturing, labeling, packaging and assembly as neededTravel (domestic and international) may be required to support new equipment purchases and/or trainingMust be able to lift/push/pull at least 40lbsKnowledge, Skills and Abilities:Demonstrated technical aptitudeKnowledge of cGMP manufacturing environment and familiarity with aseptic processing/fillingPreferred experience with aseptic technique and operating filling equipment or assembly and packaging of parenteral products in vials, syringes and cartridges using both manual and automated equipmentBasic understanding of Microsoft Office SuiteDemonstrates strong interpersonal, cross- cultural, communication, negotiation, and has a high emotional IQExhibits confidence and strong problem-solving skills and demonstrates ingenuity, creativity and resourcefulnessGains understanding from provided instructions and works towards established goalsUnderstands and listens to team members and stakeholders’ needs while supporting a positive team environmentSupports the development and maintenance of a diverse and inclusive environmentEducation and Experience:To be considered for the Associate Biotech Production Specialist role, you must have one of the following; BS/BA in Life Sciences or related field or AS/AAS Degree/Certificate in Biotechnology/Biological Science, or an equivalent combination of education and experience.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) $21.01 – $32.84

Expected salary:

Location: USA

Job date: Sun, 15 Sep 2024 01:11:30 GMT

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