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QC Micro Specialist

Regeneron

Regeneron

Rensselaer, NY, USA
Posted on Oct 26, 2024
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Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide 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.

As a QC Micro Specialist, a typical day might include the following:

  • 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 overtime.
  • Implement verified methods for Endotoxin and Bioburden testing via Change Control, support 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 to aseptic process simulations.
  • Collaborate with team members on activities associated with Change Control. This includes 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 their 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 in order 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.
  • Seek 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, this may include implementation of new specifications, design of LIMS/ELN templates for new/revised test methods, 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 develops metrics to measure the strategy.
  • Have advance Knowledge in Microbiological Test Methods (This includes, but is 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.

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 closely related field; or equivalent combination of education and experience.

  • Associate QC Micro Specialist: 0-2 years of relevant experience
  • QC Micro Specialist: 2+ years of relevant experience

Level is determined 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 (annually)

$58,480.40 - $106,300.00
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