Analytical Operations Director / Sr. Analytical Operations Director at Cerus

Concord, CaliforniaFull-timeCMCPosted 4 days 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>This is a hybrid opportunity where you'll work out of our Concord, CA office twice a week. Summary & Scope of Position: Provide strategic and operational leadership for Analytical Development and Quality Control supporting Cerus’ CMC and combination product (drug–device) programs. Responsible for oversight of analytical method lifecycle—including development, qualification, validation, transfer, and ongoing lifecycle management—ensuring compliance with global regulatory expectations and cGMP requirement. Partner cross-functionally with CMC, Device/Engineering, Quality, and Regulatory Affairs, as well as external CMOs/CDMOs to establish and maintain robust analytical and quality control strategies supporting clinical development through commercialization of Cerus’ small molecule and device-based products with select support for biologic/plasma derived components as applicable. Primary Responsibilities: <ul> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Lead and oversee the development, validation, transfer, and lifecycle management of analytical methods for drug substances, drug products, device components, raw materials, and intermediates in accordance with ICH/USP/Ph. Eur. Guidelines.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Author, review, and approve CMC sections (Module 3) for regulatory submissions, ensuring alignment with global health authority expectations for both drug and device components.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Oversee analytical and quality control activities at CMOs/CDMOs, including method transfer, performance monitoring and ensuring compliance with cGMP and quality agreements.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Lead and/or support OOS, OOT, deviations, and investigations, driving root cause analysis and effective CAPAs in collaboration with internal teams and external partners.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ensure analytical readiness to support in-process controls, release testing, stability programs, and comparability assessments across clinical and commercial stages.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ensure compliance with cGMP requirements such that products are tested against agreed specifications in timely manner to support in-process, lot release, and stability testing.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ensure phase-appropriate analytical control strategies aligned with regulatory expectations.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Serve as the analytical SME for change control and CAPA governance, ensuring appropriate impact assessments for both drug and device aspects.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Establish and justify product specifications and control strategies using sound statistical principles and risk-based approaches.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Oversee development of biological/functional assays to support plasma-derived or lyophilized biologic components, as applicable.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Drive continuous improvement initiatives to enhance analytical robustness, efficiency, and compliance across the product lifecycle.</li> </ul> Qualifications/Requirements: <ul> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">M.S. or Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, Life Sciences, or related field with 10+ years (Director) or 15+ years (Sr. Director) of relevant industry experience (B.S. with 14+ / 17+ years, respectively).</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Significant experience in analytical development and CMC support for late stage clinical and commercial programs, preferably including combination products or device related testing.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Proven experience with method validation, method transfer, specification setting, and lifecycle management.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Experience with technology transfer, process validation, and commercial launch activities.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Demonstrated leadership in technical project management, including oversight of external partners (CMOs/CDMOs).</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Strong working knowledge of cGMP, ICH guidelines, FDA/EMA expectations, and combination product regulatory frameworks.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Experience leading or supporting CAPA, change control, and investigations in a regulated environment.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Experience with biologic or plasma-derived product analytics is a plus.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Excellent communication skills with demonstrated ability to author and review regulatory submissions (CMC sections) and interact with health authorities.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ability to operate strategically and independently in a fast-paced, cross-functional environment.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Strong organizational skills and attention to detail, and ability to manage multiple concurrent priorities.</li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;">Willingness to travel up to 20% domestically and internationally.</li> </ul> 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-$225,000 annually for the Director level. Base pay is one part of the total package to compensate and recognize employees for their work.   All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

About the Role

Related Roles