Neurotech Pharmaceuticals, Inc. · 1 day ago
QC Manager
Cumberland, RI
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expNeurotech Pharmaceuticals, Inc. is a private biotech company focused on developing transformative therapies for chronic eye diseases. The QC Manager will lead microbiological quality control programs, ensuring compliance with GMP requirements and providing strategic leadership across product streams while mentoring a growing team.
Biotechnology
Responsibilities
Lead and oversee the Environmental Monitoring (EM) program, including viable and non-viable particulate monitoring, surface sampling, personnel monitoring, utility gases, purified water, and trending/reporting of results
Manage internal Microbiology laboratory operations, ensuring GMP compliance, data integrity, and timely execution of testing to support manufacturing and release activities
Serve as SME for microbiology, sterility assurance, and contamination control across Neurotech manufacturing and support areas
Provide oversight and technical review for outsourced compendial testing (e.g., bioburden, Microbial IDs, dose audits, mycoplasma, etc.) performed by contract testing organizations (CTOs)
Develop and maintain microbiological control strategies for aseptic processing areas, including management of EM limits, deviation investigations, and contamination trend analyses
Author, review, and approve technical documentation, including SOPs, EM plans, protocols, and technical reports
Support site audits and regulatory inspections/responses as the primary Microbiology & EM representative
Partner cross-functionally with Manufacturing, Facilities, and Quality Assurance to maintain a robust contamination control program
Provide mentorship, coaching, and daily leadership to Microbiology & EM analysts; establish training and competency plans for the team
Participate in risk assessments, root cause analyses, and CAPA development related to microbiological or environmental events
Support site efforts through timely design, validation, and execution of studies, protocols, reports, etc
Identify and drive continuous improvement initiatives to enhance testing efficiency, data integrity, and contamination control systems
Qualification
Required
Bachelor's or Master's degree in Microbiology, Biology, Biotechnology, or related life science
8–12 years of progressive experience in GMP Quality Control Microbiology, including direct experience managing Environmental Monitoring programs
Strong working knowledge of compendial microbiological methods (e.g., USP, etc.), aseptic techniques, and contamination control principles
Demonstrated experience leading or overseeing Microbiological testing (e.g., sterility, endotoxins, mycoplasma, etc.)
Proven track record in team leadership, mentorship, and technical development of laboratory staff
Comprehensive understanding of GMPs (21 CFR 210/211/820/ISO 13485), aseptic manufacturing, and cleanroom behavior
Excellent written, verbal, and interpersonal communication skills with the ability to interact effectively across departments
Preferred
Prior experience supporting biologics, cell therapy, or gene therapy manufacturing strongly preferred
Company
Neurotech Pharmaceuticals, Inc.
Neurotech Pharmaceuticals, Inc. is a private biotech company focused on developing transformative therapies for chronic eye diseases.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Laurie Ferguson
Chief Communications Officer (CCO)
Scott Hunter
Chief Commercial Officer
Recent News
Providence Business News
2023-09-17
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