QC Micro Specialist
: Job Details :

Job Title: QC Micro SpecialistRegeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a non-lab based position that will specialize in developing new QC microbiology test methods, providing critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained. Drives continuous improvements for microbiological methods.Responsibilities:Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity over time.Implement verified methods for Endotoxin and Bioburden testing via Change Control, supporting Data Review and Compliance records as needed.Author protocols and Summary Reports for Bioburden, and Endotoxin verification as well as Low Endotoxin Recovery/Hold studies.Applies a fundamental understanding of the science behind the microbiological assays to perform advanced troubleshooting and complete complex microbiological investigations.Leads tasks associated with aseptic process simulations.Collaborate with team members on activities associated with Change Control, including initiation, impact and implementation of the change; also the initiation and closure of workflows and CAPAs.Participate in the writing of technical documents and studies to troubleshoot and support investigations.Applies expertise in the creation and update of SOPs.Lead data gathering and analysis in support of investigations and business decision-making.Lead the evaluation of data entry, analysis, and reporting of microbiological data and support implementation of changes to identify streamlining opportunities.Participates in internal audit discussions and seeks alignment with the team to address microbial requests.Collaborates in technical discussions and problem-solving with outside entities (i.e. contract manufacturers and contract test labs) to drive resolutions.Seeks support to make good judgments and quick decisions regarding microbiological methods.Assists in the integration of technical updates into the team procedures while maintaining compliance with regulatory agencies.Implements the creation and review of LIMS configurations to meet the needs of QC-Microbiology, including implementation of new specifications, design of LIMS/ELN templates for new/revised test methods, and design of queries and reports.Assists in the collection and maintenance of reference libraries for microbiological methods.This role might be for you if you:Can facilitate with organizational agility.Assist in the development and support of strategies on how to achieve what needs to be done and develop metrics to measure the strategy.Have advanced knowledge in Microbiological Test Methods (including, but not limited to: Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities, and Disinfectants.Can resolve and negotiate conflicts or problems with tact, diplomacy, and composure.Have the ability to handle multiple priorities with exceptional organizational and time management skills.Are proficient in IOPS Systems (e.g. BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance).Can possess excellent written, verbal, and interpersonal communication skills.Minimum Requirements:To be considered for the QC Micro Specialist, you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in microbiology or a closely related field; or an equivalent combination of education and experience.Associate QC Micro Specialist: 0-2 years of relevant experienceQC Micro Specialist: 2+ years of relevant experienceLevel is determined based on qualifications relevant to the role.#LI-MB1Does 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.Salary Range (annually)$58,480.40 - $106,300.00#J-18808-Ljbffr