Principal QC Micro Specialist

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.

As a Principal 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.
• Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.
• Builds processes where gaps have been identified.
• Coordinates tasks associated to aseptic process simulations.
• Applies a fundamental understanding of the science behind the microbiological assays to perform advanced troubleshooting and complete complex microbiological investigations.
• Lead and guide 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.
• Authoring and Reviewing technical documents and studies to troubleshoot and support investigations.
• Acts as a Subject Matter Expert (SME) in the creation, update and review of SOPs.
• Review of data gathering and analysis in support of investigations and business decision making.
• Implement opportunities identified to streamline data entry, analysis, and reporting of microbiological data and support implementation of changes.
• Independently finds alternative solutions/work arounds while obtaining buy-in from the organization. Effective and out of the box problem solving. Translates ambiguity into actional steps.
• Participates in internal audit discussions and coaches team to address microbial requests.
• Participates 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.
• Ability to make good judgements and quick decisions regarding microbiological methods.
• Integrates technical updates into the team procedures while maintaining compliance with regulatory agencies.
• Leads 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.
• Builds and maintains reference libraries for microbiological methods.
• Mentors others across all aspects of the team, may mange others through influence rather than direct authority.
• Influences policy.

This role might be for you if you:

• Can facilitate with organizational agility.
• Develop and support strategies on how to achieve what needs to be done and develops metrics to measure the strategy.
• Are proficient 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.
• Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company.
• Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
• Can 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)

To be considered for the Principal 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. For various levels you must have the following:

• Principal QC Micro Specialist: 8+ years of relevant experience
• Staff QC Micro Specialist: 10+ 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, a