Analytical Operations Director / Sr. Analytical Operations Director

Cerus•Concord, CA

1d•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 where you'll work out of our Concord, CA office twice a week. 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.

Requirements

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).
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.
Experience leading or supporting CAPA, change control, and investigations in a regulated environment.
Excellent communication skills with demonstrated ability to author and review regulatory submissions (CMC sections) and interact with health authorities.
Ability to operate strategically and independently in a fast-paced, cross-functional environment.
Strong organizational skills and attention to detail, and ability to manage multiple concurrent priorities.
Willingness to travel up to 20% domestically and internationally.

Nice To Haves

Experience with biologic or plasma-derived product analytics is a plus.

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.
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.
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.