Technical Operations Manager CMC at Cerus

Concord, CaliforniaFull-timeCMCPosted about 2 months ago

About the Role

<div class="content-intro">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.</div><h2>This is a hybrid opportunity based out of Concord, CA where you'll work twice a week in the office.</h2> <h1>Position Summary</h1> 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. <h1>Primary Responsibilities</h1> <ul> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Provide technical expertise for development and commercial products.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Support process development, characterization, scale-up, analytical (development, release and stability testing) and commercialization activities internally and at CMOs.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Support manufacturing and analytical testing-related investigations</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Manage change controls, deviations, CAPAs, and risk assessments.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Lead stability programs for API and combination drug product.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ensure compliance with FDA, EMA, ICH, USP, ISO, and ASTM requirements.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Author and review technical documentation, specifications, protocols, and reports.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Author, review, interpret data for CMC sections for global regulatory submissions.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Collaborate with RA, QA, Supply Chain, Manufacturing, and R&D teams.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Manage shipping and receiving activities for clinical and development materials, ensuring compliance with applicable quality and regulatory requirements.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Coordinate inventory management activities, including tracking of raw materials, components, consumables, reference standards, and development samples.</li> </ul> Qualifications <ul> <li>B.S or M.S. in, Pharmaceutical Sciences, Chemistry, Biomedical Engineering, or related scientific discipline preferred.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">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</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Demonstrated success managing CMOs and cross-functional project teams.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Excellent technical writing, communication, and project management skills.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">AI-enabled process and analytical development and manufacturing optimization is a plus.</li> </ul> <h1>Travel</h1> 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.

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