About Cerus:
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.
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.
- 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.
Qualifications
- 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.
- AI-enabled process and analytical development and manufacturing optimization is a plus.
Up to 15% domestic and international travel as required.
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.
Skills Required
- Bachelor’s or master’s degree in Pharmaceutical Sciences, Chemistry, Biomedical Engineering, or a related scientific discipline
- 10 years of experience in pharmaceutical, biotechnology, medical device, or combination product industries
- At least 5 years of experience with CMC development, process validation, analytical development and validation, stability management, technology transfer, change controls, and regulatory submissions
- Demonstrated success managing contract manufacturing organizations and cross-functional project teams
- Excellent technical writing and communication skills
- Project management skills
- Experience supporting global regulatory filings and product lifecycle management
What We Do
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
