Regeneron

QC Microbiology Scientist

RENSS - TECH VALLEY Full time

Regeneron is currently looking for a QC (Quality Control) Microbiology Scientist to join our QC Technical Resources team. This position will specialize in microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. They will ensure departmental compliance to regulatory guidelines are maintained and drive continuous improvements for microbiological methods.

A typical day as a QC Microbiology Scientist might include:

  • Perform Test Method validations, studies, and assisting on troubleshooting efforts (Investigations).
  • Participate on building processes where gaps have been identified.
  • Participates on tasks associated to aseptic process simulations.
  • Assist with activities associated with Change Control. This includes initiation, impact and implementation of the change; also the initiation and closure of workflows and CAPAs.
  • Assist with the writing of technical documents and studies to troubleshoot and support investigations.
  • Assist with the creation and update of SOPs.
  • Captures data for the analysis in support of investigations and business decision making.
  • Evaluate data entry, analysis, and reporting of microbiological data and support implementation of changes in order to identify streamlining opportunities.
  • Seeks and evaluates alternative solutions while acquiring agreement from the organization. Effective and out of the box problem solving. Assists in the translation of ambiguity into actionable steps.
  • Assist in internal audit discussions and aligns with the team to address microbial requests.
  • Assist the team in technical discussions and problem solving with outside entities (i.e. contract manufacturers and contract test labs) to drive resolutions.
  • Effectively communicate technical solutions to others in the organization.
  • Participate in the integration of technical updates into the team procedures while maintaining compliance with regulatory agencies.
  • Assist in 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.
  • Suggest the incorporation of new items to the reference libraries for microbiological methods.

This role might be for you if you:

  • 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 knowledge of Microbiological Test Methods (Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility etc.) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants
  • Possesses excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company.
  • Resolves and negotiates conflicts or problems with tact, diplomacy and composure.
  • Able to prioritize multiple priorities with outstanding organizational and time management skills.
  • Proficient in IOPS Systems (e.g. BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance).

To be considered for the QC Microbiology Scientist you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Life sciences, microbiology or biology is preferred. For various levels you must have the following:

  • QC Microbiology Scientist: 2+ years of relevant experience
  • Sr. QC Microbiology Scientist:5+ years of relevant experience

Previous experience working in a microbiology lab or pharmaceutical microbiology lab is preferred. 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 culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, 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) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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)

$67,400.00 - $128,700.00