CMC Technical Operations Lead - Pharma/Devices (Hybrid, Concord)

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) matching

RSUs

Paid maternity/paternity leave

Job summary

Cerus is seeking an experienced Technical Operations Manager with expertise in CMC to drive process development, validation, technology transfer, manufacturing and analytical support for medical device and pharmaceutical products.

The role collaborates with internal teams, CMOs, CTLs, and regulatory partners to ensure successful global filings and lifecycle management, with up to 15% travel and a focus on compliant, scalable operations.

Qualifications

• Bachelor’s or Master’s degree in a relevant scientific field is required or preferred.
• 10 years in pharma/biotech/medical device or combination product industries with 5+ years in CMC development, validation, tech transfer, and regulatory submissions.

Responsibilities

• Provide technical expertise for development and commercial products across CMC.
• Support process development, scale‑up, analytical development, release, and stability testing.
• Coordinate with CMOs, CTLs, and regulatory partners for technology transfer and validation.
• Manage change controls, deviations, CAPAs, and risk assessments.
• Lead stability programs for API and drug products.
• Ensure compliance with FDA, EMA, ICH, USP, ISO, and ASTM standards.
• Prepare and review technical documentation and CMC sections for global submissions.
• Collaborate with RA, QA, Supply Chain, Manufacturing and R&D teams.

Skills

CMC leadership

Regulatory submissions

Project management

Technical writing

Education

BS/MS in Pharmaceutical Sciences, Chemistry, Biomedical Engineering or related

Job description

Cerus is seeking an experienced Technical Operations Manager with expertise in CMC to drive process development, validation, technology transfer, manufacturing and analytical support for medical device and pharmaceutical products.

The role collaborates with internal teams, CMOs, CTLs, and regulatory partners to ensure successful global filings and lifecycle management, with up to 15% travel and a focus on compliant, scalable operations.