Regeneron is currently looking for a QC Micro Specialist to join our QC (Quality Control) Microbiology Tech team. This position 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 Alternative and Rapid Technologies associated with Microbiological Assays. 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:
Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures.
Leading Test Method validations, studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.
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 have a BS/BA in microbiology or closely related field or equivalent combination of education and experience. For various levels you must have the following:
Assoc QC Micro Specialist: 0-2 years of relevant experience
QC Micro Specialist: 2+ years of relevant experience
Sr QC Micro Specialist: 5+ years of relevant experience
Level is determined based on qualifications relevant to the role.#LI-MB1Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually)$58,480.40 - $124,300.00