Technical Operations Manager CMC

Cerus•Concord, CA

3d•$160,000 - $175,000•Hybrid

About The Position

Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world. This is a hybrid opportunity based out of Concord, CA where you'll work twice a week in the office. Cerus is seeking an experienced Technical Operations Manager with expertise across Chemistry, Manufacturing, and Controls (CMC) activities supporting commercial and development-stage products. This role will serve as a key technical resource responsible for driving process development, process validation, technology transfer, manufacturing and analytical support, regulatory submissions, and lifecycle management activities across medical device, pharmaceutical, small and large molecule combination products. The role will work closely with internal cross-functional teams, Cerus internal development and analytical laboratories, contract manufacturing organizations (CMOs) contract testing laboratories (CTLs), and regulatory partners to ensure successful execution of CMC programs. The individual will leverage internal laboratory capabilities where appropriate while coordinating and overseeing external partners to execute analytical development and testing, process development, technology transfer, validation, and manufacturing activities. The ideal candidate will possess deep expertise in pharmaceutical and/or medical device manufacturing, analytical sciences, regulatory compliance, process validation, and commercialization activities, with demonstrated success supporting global regulatory filings and product lifecycle management. In addition, the role will provide operational oversight for site activities including material management, shipping and receiving, inventory control, and equipment maintenance and coordination of internal and external technical resources to ensure efficient execution of development and manufacturing programs.

Requirements

B.S or M.S. in, Pharmaceutical Sciences, Chemistry, Biomedical Engineering, or related scientific discipline preferred.
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
Demonstrated success managing CMOs and cross-functional project teams.
Excellent technical writing, communication, and project management skills.

Nice To Haves

AI-enabled process and analytical development and manufacturing optimization is a plus.

Responsibilities

Provide technical expertise for development and commercial products.
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.
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.
Author, review, interpret data for CMC sections for global regulatory submissions.
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.
Coordinate inventory management activities, including tracking of raw materials, components, consumables, reference standards, and development samples.