CMC Operations Manager — Pharma/Med Device (Hybrid)

Cerus Corporation; Concord (CA); Hybrid; USD 160,000 - 175,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) matching

RSUs

Job summary

Cerus Corporation in Concord, California, is seeking an experienced Technical Operations Manager with deep CMC expertise to drive process development, validation, and tech transfer for medical device and pharmaceutical products. You will coordinate internal teams, CMOs, and external labs to ensure compliant development, scale-up, and regulatory submissions.

The role emphasizes collaboration across QA, RA, Manufacturing, and R&D, with responsibilities spanning material management, inventory, and

Qualifications

• Bachelor's or Master’s degree in a relevant scientific field.
• Progressive experience in CMC development, process validation, and regulatory submissions.

Responsibilities

• Provide technical expertise for development and commercial products across CMC.
• Support process development, characterization, scale-up, analytical testing, and technology transfer internally and at CMOs.
• Manage change controls, deviations, CAPAs, and risk assessments.
• Lead stability programs for API and combination products.
• Ensure compliance with FDA, EMA, ICH, USP, ISO, and ASTM requirements.
• Author and review technical documentation and data for regulatory submissions.

Skills

Project management

Technical writing

Communication

Regulatory submissions

Education

B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biomedical Engineering, or related discipline

Tools

CMO management

Job description

Cerus Corporation in Concord, California, is seeking an experienced Technical Operations Manager with deep CMC expertise to drive process development, validation, and tech transfer for medical device and pharmaceutical products. You will coordinate internal teams, CMOs, and external labs to ensure compliant development, scale-up, and regulatory submissions.

The role emphasizes collaboration across QA, RA, Manufacturing, and R&D, with responsibilities spanning material management, inventory, and