CMC Operations Lead – Pharma/Devices (Hybrid)

Cerus; Concord (CA); Híbrido; USD 160.000 - 175.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision

Domestic partner benefits

RSUs

401(k) matching

Descripción de la vacante

Cerus is seeking an experienced Technical Operations Manager for Concord, CA, with strong CMC and regulatory expertise. The role covers development through lifecycle management of medical device and drug products, with collaboration across internal labs, CMOs, and regulatory partners.

The position is hybrid, requiring in-office presence twice a week. The ideal candidate has deep experience in manufacturing analytics, process validation, technology transfer, and regulatory filings to support

Formación

• 10 years in pharma/biotech/medical device or combination products with at least 5 years in CMC development, process validation, analytical development and regulatory submissions.
• Experience managing CMOs and cross-functional project teams.
• Excellent technical writing, communication, and project management skills.
• AI-enabled process and analytical development and manufacturing optimization is a plus.

Responsabilidades

• Provide technical expertise for development and commercial products.
• Support process development, characterization, scale-up, analytical development and commercialization with internal teams and CMOs.
• Support manufacturing and analytical testing-related investigations.
• Manage change controls, deviations, CAPAs, and risk assessments.
• Lead stability programs for API and combination drug product.
• Ensure compliance with FDA, EMA, ICH, USP, ISO, and ASTM requirements.
• Author and review technical documentation, specifications, protocols, and reports.
• Collaborate with RA, QA, Supply Chain, Manufacturing, and R&D teams.
• Coordinate shipping and receiving activities and manage inventory.

Conocimientos

CMC development

Process validation

Tech transfer

Analytical development

Regulatory submissions

Technical writing

Project management

Cross-functional collaboration

AI optimization

Educación

B.S. or M.S. in Pharmaceutical Sciences

Descripción del empleo

Cerus is seeking an experienced Technical Operations Manager for Concord, CA, with strong CMC and regulatory expertise. The role covers development through lifecycle management of medical device and drug products, with collaboration across internal labs, CMOs, and regulatory partners.

The position is hybrid, requiring in-office presence twice a week. The ideal candidate has deep experience in manufacturing analytics, process validation, technology transfer, and regulatory filings to support