QC Manager

NEUROTECH U S A-posted 23 days ago
Full-time • Mid Level
Cumberland, RI
51-100 employees
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Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform, Encapsulated Cell Technology (ECT), designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, by leveraging ECT's innovative approach providing sustained, targeted treatment directly to the eye. The Manager, Quality Control Microbiology & Environmental Monitoring (EM), is responsible for leading all microbiological quality control programs at Neurotech, including oversight of environmental monitoring, sterility assurance, endotoxins, and mycoplasma testing programs. While certain compendial assays are performed by external contract laboratories, this position ensures method oversight, data review, and vendor compliance with GMP requirements. This role serves as the site subject matter expert (SME) for microbiology and contamination control and provides strategic and technical leadership across multiple product streams. The Manager will mentor and develop a growing Microbiology team, ensuring operational excellence, inspection readiness, and the highest standards of data integrity and GMP compliance in support of Neurotech’s clinical and commercial manufacturing operations.

  • 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.
  • 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 <61>, <63>, <71>, <85>, <1072>, <1116>, <1117>, <1118>, 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.
  • Prior experience supporting biologics, cell therapy, or gene therapy manufacturing strongly preferred.
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