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. This is a hybrid opportunity where you'll work out of our Concord, CA office twice a week. We are open to both levels Associate Director or Director.

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.

Responsibilities

: 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.

Author, review, and approve CMC sections (Module 3) for regulatory submissions, ensuring alignment with global health authority expectations for both drug and device components. Oversee analytical and quality control activities at CMOs/CDMOs, including method transfer, performance monitoring and ensuring compliance with cGMP and quality agreements. Lead and/or support OOS, OOT, deviations, and investigations, driving root cause analysis and effective CAPAs in collaboration with internal teams and external partners.

Ensure analytical readiness to support in-process controls, release testing, stability programs, and comparability assessments across clinical and commercial stages.

Requirements

such that products are tested against agreed specifications in timely manner to support in-process, lot release, and stability testing. Ensure phase-appropriate analytical control strategies aligned with regulatory expectations. Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines.

Serve as the analytical SME for change control and CAPA governance, ensuring appropriate impact assessments for both drug and device aspects. Establish and justify product specifications and control strategies using sound statistical principles and risk-based approaches. Oversee development of biological/functional assays to support plasma-derived or lyophilized biologic components, as applicable.

Drive continuous improvement initiatives to enhance analytical robustness, efficiency, and compliance across the product lifecycle.

S. D. in Analytical Chemistry, Organic Chemistry, Biochemistry, Life Sciences, or related field with 10+ years (Director) or 15+ years (Sr.

S. with 14+ / 17+ years, respectively). Significant experience in analytical development and CMC support for late stage clinical and commercial programs, preferably including combination products or device related testing.

Proven experience with method validation, method transfer, specification setting, and lifecycle management. Experience with technology transfer, process validation, and commercial launch activities. Demonstrated leadership in technical project management, including oversight of external partners (CMOs/CDMOs).

Strong working knowledge of cGMP, ICH guidelines, FDA/EMA expectations, and combination product regulatory frameworks.

Qualifications

Associate Director, Analytical Operations / Analytical Operations Director