Manager, External Manufacturing

Neurona Therapeutics; South San Francisco (CA); On-site; USD 140,000 - 205,000; Full time

Job summary

Neurona Therapeutics in South San Francisco, CA is seeking a Manager, External Manufacturing to oversee external manufacturing partners and clinical supply for our cell therapy pipeline. You will serve as the primary liaison to CMOs/CDMOs, coordinating manufacturing campaigns, material planning, and supply continuity.

In this hybrid office role, you will ensure GMP/GCP compliance, manage risk, and drive on-time delivery across cross-functional teams including Technical Operations, CMC, Quality,

Qualifications

• Experience managing external manufacturing partnerships and clinical supply.
• Strong ability to forecast supply needs and risk from vendors.
• Experience in cell therapy or biologics is preferred.

Responsibilities

• Manage day-to-day relationships with CMOs/CDMOs and suppliers, including schedules, deliverables, costs, and invoices.
• Develop manufacturing and clinical supply plans aligned with timelines, enrollment forecasts, inventory, lead times, and expiry.
• Coordinate manufacturing activities, campaigns, transfers, materials, and shipments with external partners.
• Forecast clinical supply needs and manage inventory, safety stock, reorder points, expiry, and risks of stockouts or excess.
• Coordinate procurement and availability of critical raw materials and manufacturing supplies.
• Coordinate clinical supply distribution to depots and sites, including cold-chain and international shipments.
• Monitor supplier performance and mitigate risks related to capacity, materials, quality, and lead times.
• Ensure GMP/GCP compliance and collaboration with QA, Regulatory, and Clinical Ops.
• Maintain audit-ready documentation and SOPs for manufacturing and supply activities.
• Travel occasionally for in-person meetings with contractors or vendors.

Skills

Project management

Cross-functional collaboration

Analytical skills

Communication

Supply chain planning

Education

Bachelor's degree in Supply Chain, Operations, Life Sciences, Engineering, or related field

Advanced degree preferred

Tools

CMO/CDMO management tools

IRT/IVRS/IWRS systems

GMP/GCP knowledge

Job description

Location: South San Francisco, CA, 94080

Job Type: Full Time

Work Type: On-Site

Position Summary

At Neurona Therapeutics, we are developing transformative cell therapies for patients with serious neurological disorders. We are seeking a Manager, External Manufacturing, to be responsible for managing external manufacturing partners and clinical supply activities supporting the company’s cell therapy pipeline. The role will serve as the primary point of contact for assigned CMOs/CDMOs and critical suppliers while also leading clinical supply planning, inventory management, and distribution activities.

This role will ensure manufacturing capacity, materials, clinical supply, quality, and timelines are aligned with program needs. The Manager will work closely with Technical Operations, CMC, Quality, Clinical Operations, Procurement, Regulatory, and other cross-functional teams to manage external partners, anticipate supply risks, and ensure reliable and compliant clinical supply. This is a hybrid office role for our South San Francisco, CA headquarters.

Key Responsibilities

• Manage day-to-day relationships with CMOs/CDMOs and critical suppliers, including schedules, deliverables, performance, costs, and invoices.
• Develop and maintain manufacturing and clinical supply plans aligned with clinical timelines, enrollment forecasts, demand, inventory, lead times, and product expiry.
• Coordinate manufacturing activities, campaigns, technology transfers, materials, shipments, and deliverables with external partners.
• Forecast clinical supply requirements and manage inventory, safety stock, reorder points, product expiry, and potential stockout or excess supply risks.
• Coordinate procurement and availability of critical raw materials, components, and manufacturing supplies.
• Coordinate clinical supply distribution from CMOs/CDMOs to depots and clinical sites, including cold-chain and international shipments.
• Monitor CMO/CDMO and supplier performance and proactively identify and mitigate risks related to capacity, materials, quality, lead times, cost, and supply continuity.
• Partner with Technical Operations, CMC, and Quality on supplier qualification, deviations, changes, investigations, audits, inspections, and other GMP activities.
• Ensure external manufacturing and clinical supply activities comply with applicable GMP, GCP, regulatory, and company requirements, including appropriate controls for clinical trial blinding where applicable.
• Maintain accurate, audit-ready SOPs, trackers, records, and documentation related to manufacturing, inventory, shipments, reconciliations, and supply activities.
• Partner with Clinical Operations, Logistics, Regulatory, and other stakeholders on site activation, enrollment, IRT/IVRS/IWRS parameters, resupply, import/export, and country-specific supply requirements.
• Develop contingency plans and alternate-source strategies for critical materials, manufacturing activities, and clinical supply needs.
• Provide regular updates on manufacturing and clinical supply status, risks, issues, and mitigation plans to cross-functional and program leadership.
• Occasional travel is required to sites for face-to-face meetings with contractors and/or vendors.

Qualifications

• Bachelor's degree in Supply Chain, Operations, Life Sciences, Engineering, Business, or a related field; advanced degree preferred.
• 8+ years of experience in biotechnology, pharmaceutical, cell therapy, biologics, or another GMP-regulated environment, with meaningful experience in both external manufacturing and clinical supply.
• Demonstrated experience managing CMOs/CDMOs and external suppliers, including manufacturing schedules, material planning, performance management, and issue resolution.
• Strong experience with clinical supply planning, forecasting, inventory management, clinical distribution, and supply risk management.
• Experience supporting clinical-stage programs and working cross-functionally with Technical Operations/CMC, Quality, Clinical Operations, Regulatory, Procurement, and Logistics.
• Cell therapy, gene therapy, biologics, or other advanced therapy experience strongly preferred.
• Working knowledge of GMP, GCP, clinical supply-chain processes, and pharmaceutical/biotechnology manufacturing operations.
• Experience with IRT/IVRS/IWRS systems and clinical supply parameters preferred.
• Strong project management, analytical, organizational, and communication skills, with the ability to manage multiple external partners and competing priorities.
• Demonstrated ability to anticipate supply risks, develop mitigation and contingency plans, and drive complex issues through resolution in a fast-paced environment.

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.

Alert

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.

If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://www.cisa.gov/be-cyber-smart/report-incident to learn how to report it.