Principal QC Microbiology Scientist

Regeneron Pharmaceuticals • Rensselaer, NY

6d • Onsite

About The Position

Regeneron is currently looking for a Principal 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 Principal QC Microbiology Scientist might include: Ensure QC microbiological compliance with cGMP standards. Conduct microbiological validations for raw materials, finished products, in-process controls, and buffers. Participate in cleaning and process validation activities involving microbiology. Investigate and review alert and action limits, microbiological product OOS results and DNFs, implementing corrective actions as needed. Develop, validate, and troubleshoot microbiological test methods, including rapid and alternative technologies. Lead data gathering, analysis and reporting to support investigations and streamline processes. Lead and participate in validations, studies, and investigations at CMO/CLOs and apply advanced scientific expertise to resolve complex issues. Create, revise, and review microbiological documentation. Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed. Support the maintenance of reference libraries for microbiological methods. Participate in internal audits, technical discussions and problem-solving with external entities. Assist in the integration of technical updates into team procedures while maintaining regulatory compliance. Provide technical advice to manufacturing personnel and effectively communicate solutions with the organization. Drive continuous improvement of microbiological methods by staying current with industry trends, implementing updates into QC practices, and onboarding alternative and rapid technologies while serving as the SME for these innovations. Contribute to the preparation and revision of technical proposals, amendments, reports, memoranda, and microbiological SOP. Represent microbiology in cross-functional site meetings and provide technical advice to manufacturing personnel. Participate in the transfer of methodologies to and from other test facilities. Assist in the preparation for internal, customer, and regulatory inspections. Proactively identify and implement laboratory process improvements and lean initiatives. Drive the integration of alternative and rapid technologies into QC practices. 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).

Requirements

• BS/BA in Life sciences, microbiology or biology is preferred
• 8+ years of relevant experience
• Willing and able to work Monday-Friday, 8am-4:30pm
• 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).

Nice To Haves

• Previous experience working in a microbiology lab or pharmaceutical microbiology lab is preferred.

Responsibilities

• Ensure QC microbiological compliance with cGMP standards.
• Conduct microbiological validations for raw materials, finished products, in-process controls, and buffers.
• Participate in cleaning and process validation activities involving microbiology.
• Investigate and review alert and action limits, microbiological product OOS results and DNFs, implementing corrective actions as needed.
• Develop, validate, and troubleshoot microbiological test methods, including rapid and alternative technologies.
• Lead data gathering, analysis and reporting to support investigations and streamline processes.
• Lead and participate in validations, studies, and investigations at CMO/CLOs and apply advanced scientific expertise to resolve complex issues.
• Create, revise, and review microbiological documentation.
• Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
• Support the maintenance of reference libraries for microbiological methods.
• Participate in internal audits, technical discussions and problem-solving with external entities.
• Assist in the integration of technical updates into team procedures while maintaining regulatory compliance.
• Provide technical advice to manufacturing personnel and effectively communicate solutions with the organization.
• Drive continuous improvement of microbiological methods by staying current with industry trends, implementing updates into QC practices, and onboarding alternative and rapid technologies while serving as the SME for these innovations.
• Contribute to the preparation and revision of technical proposals, amendments, reports, memoranda, and microbiological SOP.
• Represent microbiology in cross-functional site meetings and provide technical advice to manufacturing personnel.
• Participate in the transfer of methodologies to and from other test facilities.
• Assist in the preparation for internal, customer, and regulatory inspections.
• Proactively identify and implement laboratory process improvements and lean initiatives.
• Drive the integration of alternative and rapid technologies into QC practices.

Benefits

• 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
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees