Job Details

Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for intractable neurological diseases. Neurona Therapeutics is seeking an exceptional candidate to join our Quality Control (QC) team. Our ideal candidate is a self-motivated individual who has a passion for QC Microbiology and can thrive in a fast-paced dynamic environment.

The QC Manager of Microbiology will provide scientific and technical expertise in support of microbiological quality control for a GMP cell therapy production facility. This role is responsible for overseeing microbiological testing, environmental monitoring, method development/validation, and regulatory compliance to ensure the safety, sterility, and quality of cell therapy products. The QC Manager of Microbiology performs meticulous assessment of contamination risks throughout the manufacturing process to uphold regulatory compliance and product integrity. The QC Manager of Microbiology will also act as a subject matter expert (SME) for microbiology-related investigations, support regulatory filings, and provide mentorship to junior QC and manufacturing staff.

Specific areas of responsibility include, but are not limited to, design and oversee: the environmental monitoring program (EM), the personnel monitoring program (PM), all in-process and release testing (microbiology), all raw materials testing (microbiology), method establishment of microbiological assays, aseptic processing training program, utilities testing program (microbiology), and facilities qualification (EMPQ). This position interacts cross-functionally with the Manufacturing, Operations, Regulatory, and Quality Assurance groups to ensure that all manufacturing areas are maintained in a state of control in accordance with applicable regulatory and compliance guidelines.

Responsibilities:

• Lead, design, and execute viable and non-viable EM programs for cleanrooms, equipment, and personnel in compliance with USP, EP, and FDA/EMA guidelines.
• Trend, analyze, and report EM and utility data; recommend corrective/preventive actions where appropriate
• Lead validation and qualification of microbiological test methods in accordance with USP, Ph. Eur., ICH, and FDA guidance.
• Perform microbiological test methods as needed.
• Author and review protocols, reports, and SOPs for microbiology methods and equipment
• Serve as QC Microbiology SME during audits and regulatory inspections.
• Serve as SME for contamination control, aseptic processes, and sterility assurance programs including process simulations, traffic patterns, gowning procedures, and disinfection protocols.
• Lead or support laboratory investigations, root cause analysis, and implementation of CAPAs related to microbiological events.
• Ensure data integrity, ALCOA++ principles, and compliance with GMP regulations.
• Partner with Manufacturing, QA, Facilities, and Process Development to support contamination control strategies.
• Lead comprehensive risk assessments related to contamination control and develop mitigation strategies to ensure product quality and patient safety.
• Mentor, train, and provide technical guidance to QC and Manufacturing staff.
• Contribute to continuous improvement of QC systems, workflows, and training programs.
• Conduct contamination control risk assessments to identify potential sources of microbial contamination in the manufacturing environment.
• Implement and maintain effective contamination control strategies, including environmental monitoring programs.
• Collaborate with cross-functional teams to investigate and resolve microbiological deviations, implementing corrective and preventive actions as necessary.
• Identify and support resolution of technical problems.
• Actively participate in group and project teamwork, project and process improvements.
• Perform other duties as requested by supervisor/manager to support Quality.
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.
• Ensure good working relationships with the site management and all other departments.
• Manage operational performance using key performance indicators.
• Promote a safe working environment, report potential hazards, and ensure all direct reports follow the Environmental Health and Safety procedures.

Required Qualifications:

• Minimum of 6 years of QC microbiology experience in a GMP-regulated environment (cell therapy, biologics, or sterile pharmaceutical manufacturing strongly preferred).
• Proven expertise in microbial testing, environmental monitoring, aseptic techniques, and contamination control.
• Strong, demonstrated knowledge of applicable regulations and guidance (EU GMP Annex 1; USP <61>, <62>, <71>, <85>, <1116>, <1117>, EP, ICH Q-series, FDA/EMA cell therapy guidance).
• Strong understanding of contamination control principles and risk assessment methodologies.
• Excellent organizational skills, with the ability to manage multiple priorities under GMP timelines.
• Strong leadership, mentoring, and team-building abilities.
• Exceptional technical writing, data analysis, and problem-solving skills.
• Effective communicator, capable of interacting with cross-functional teams and external auditors.
• Comfortable in a fast-paced, dynamic environment supporting clinical and commercial manufacturing.
• Adhere to cGMP policies and procedures, including documentation activities
• Flexibility to support business needs during peak periods.
• Able to wear appropriate personal protective equipment
• Able to work collaboratively to respond to changing priorities and challenges
• Communicate effectively with team members and contribute to a positive and collaborative work environment
• Actively participate in group and project teamwork, project and process improvements
• Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Education Requirements:

• BA/BS degree in Microbiology, Biology, or related field and at least 6 years of QC microbiology experience in a GMP-regulated environment.

Interested in learning more about our science and our team? Please visit our website at www.neuronatherapeutics.com.

Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.