Manufacturing Manager at Neurona Therapeutics

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Jul, 26

Salary

0.0

Posted On

14 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Cell therapy manufacturing, cGMP operations, Aseptic processing, Biologics operations, Team leadership, Process troubleshooting, Quality systems, Regulatory compliance, Inventory control, CAPA implementation, Performance management, Data integrity, Facility commissioning, Supply chain management, Operational excellence

Industry

Biotechnology Research

Description

```html MANUFACTURING MANAGER Location: South San Francisco, CA, 94080 ABOUT NEURONA THERAPEUTICS Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on developing neuronal cell-based therapies for intractable neurological diseases. We are seeking an exceptional candidate to join our Process Sciences and Manufacturing team. The ideal candidate brings both strategic and hands-on experience in cell therapy manufacturing and is excited to help shape Neurona’s evolving technical operations. This role is critical to ensure our manufacturing programs are executed safely, compliantly, and efficiently as we advance through clinical development and scale for future growth. ROLE OVERVIEW The Manager, Manufacturing, will report directly to the Director, Manufacturing, and lead day-to-day cGMP operations for Neurona’s cell therapy products. This role is responsible for managing production teams, ensuring operational excellence, supporting regulatory compliance, and fostering a culture of accountability, safety, and continuous improvement. The Manager will play a critical role in coaching and developing personnel while partnering with Quality, Process Sciences, and site teams to deliver high-quality, scalable manufacturing processes. RESPONSIBILITIES * Lead and develop manufacturing teams on the production floor, including scheduling, coaching, performance management, and career development. * Oversee the execution of cGMP manufacturing activities for neuronal cell-based therapies across multiple campaigns and projects. * Ensure full compliance with cGMP, GxP, and regulatory requirements (US/EU), as well as internal SOPs and quality systems. * Support onboarding and training of personnel to ensure operational readiness and compliance. * Troubleshoot technical and operational challenges, providing solutions to maintain continuous production flow. * Collaborate with Quality and Process Science teams to implement CAPAs and resolve deviations or non-conformances effectively. * Manage raw materials and consumables, including inventory control, receiving, storage, and production readiness. * Support the implementation of new equipment, raw materials, and processes, ensuring safety and compliance considerations are addressed. * Participate in process qualification, facility commissioning, and readiness activities for production. * Monitor key operational metrics and develop action plans to drive continuous improvement. * Promote a safe working environment and ensure adherence to Environmental Health and Safety procedures. * Foster a culture of accountability, collaboration, and compliance within the manufacturing team. * Serve as a role model for GMP, GxP, and Data Integrity best practices on the manufacturing floor. REQUIRED QUALIFICATIONS * 8+ years of manufacturing experience in biologics operations; cell therapy experience strongly preferred. * Hands-on experience with all aspects of cell therapy manufacturing: aseptic processing, expansion/differentiation of allogenic or autologous products, 3D/adherent cultures, and formulation/fill of cellular therapeutics. * Proven leadership skills with experience managing teams, coaching, and developing personnel. * Demonstrated ability to troubleshoot manufacturing processes, resolve complex issues, and implement continuous improvement initiatives. * Knowledge of cGMP regulations, Quality Systems, and applicable regulatory standards (US/EU). * Experience collaborating cross-functionally to implement CAPAs and maintain compliance. * Experience managing materials and supply chain processes, including raw material handling, inventory control, and production readiness. * Excellent communication, interpersonal, and organizational skills, with ability to influence and lead teams effectively. EDUCATION REQUIREMENTS * Bachelor of Science required, advanced degree preferred. * 8–12 years of industrial/manufacturing experience in biologics or cell therapy strongly preferred. This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment. Recruitment Fraud Notice We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position. ```

Responsibilities

The Manufacturing Manager will lead day-to-day cGMP operations, overseeing production teams and ensuring compliance with regulatory standards. They are responsible for coaching personnel, troubleshooting technical challenges, and collaborating with cross-functional teams to maintain high-quality manufacturing processes.