Cerus
Technical Operations Manager CMC
Concord, California · Senior
Sponsorship not specified$160k-$175kDetected 24 days ago
ComplianceProduct ManagementProject ManagementSupply ChainInventory ManagementFDA RegulatoryMedical DevicesCommunicationWriting
Stay score
odds of building a lasting career here
59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
Level I$80,9331 entry
Level II$128,8352 entries
Level III$176,7583 entries
Level IV$224,6614 entries
Level III starts at $176,758 — $16,758 above the bottom of this range, and above its posted ceiling.
DOL prevailing wage, 2026-27 wage year · General and Operations Managers (11-1021) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- Cerus is seeking an experienced Technical Operations Manager with expertise across Chemistry, Manufacturing, and Controls (CMC) activities supporting commercial and development-stage products.
Responsibilities
- Support process development, characterization, scale-up, analytical (development, release and stability testing) and commercialization activities internally and at CMOs.
- Support manufacturing and analytical testing-related investigations
- Manage change controls, deviations, CAPAs, and risk assessments.
- Collaborate with RA, QA, Supply Chain, Manufacturing, and R&D teams.
- Manage shipping and receiving activities for clinical and development materials, ensuring compliance with applicable quality and regulatory requirements.
Requirements
- Up to 15% domestic and international travel as required.
- 10 years of experience in pharmaceutical, biotechnology, medical device, or combination product industries with a minimum of 5 years experience with CMC development, process validation, analytical development and validation, stability management, tech transfer, change controls, and regulatory submissions preferred
- We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.
- Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), RSUs
- Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
- Compensation: The base salary range for this position in the selected city is $160,000-$175,000 annually. Base pay is one part of the total package to compensate and recognize employees for their work.
Nice to have
- Provide technical expertise for development and commercial products.
- Ensure compliance with FDA, EMA, ICH, USP, ISO, and ASTM requirements.
- Author and review technical documentation, specifications, protocols, and reports.
- Author, review, interpret data for CMC sections for global regulatory submissions.
- Coordinate inventory management activities, including tracking of raw materials, components, consumables, reference standards, and development samples.
- B.S or M.S. in, Pharmaceutical Sciences, Chemistry, Biomedical Engineering, or related scientific discipline preferred.
- Demonstrated success managing CMOs and cross-functional project teams.
- Excellent technical writing, communication, and project management skills.
Compensation
- The base salary range for this position in the selected city is $160,000-$175,000 annually.
- Base pay is one part of the total package to compensate and recognize employees for their work.
Benefits
- EAP, legal and financial services, health club membership discounts, tuition reimbursement
Company info
- Base pay is one part of the total package to compensate and recognize employees for their work.
This listing is sourced directly from Cerus's careers page and normalized into a canonical job model.