Director/Senior Director of Analytical
The Director/Senior Director of Analytical will lead the Analytical teams, collaborating with the Director of Process Development, Head of Cell Science in Redmond, WA, and CMC leads in Chengdu.
Key Responsibilities
Leadership & Strategy: Manage and mentor Analytical teams. Develop strategies for analytical method development, validation, and tech transfer. Drive innovation in integrated discovery and manufacturability for novel biologics.
Analytical Strategy Development: Develop and implement analytical strategies to support antibody and ADC development, including phase-appropriate analytical development, characterization, and release strategies. Collaborate with cross-functional teams to establish critical quality attributes (CQAs) and specifications. Oversee analytical development, release, and stability testing at external partners. Ensure the integrity, organization, and integration of analytical datasets, supporting development and regulatory submissions. Support regulatory filings (e.g., IND, BLA) with robust analytical data and interpretation.
Integration & Collaboration: Partner closely with the Director of Process Development for PAT workflows. Participate in cross-functional PD/CMC working groups to meet project milestones. Work closely with the manufacturing facility and R&D center in Chengdu to ensure alignment in process development, scale-up, and manufacturing activities. Facilitate technology transfer and ensure consistency between sites, maintaining high-quality standards and regulatory compliance. Identify and manage processes, and ensure successful technology transfer for scale-up and GMP manufacturing, particularly between the U.S. and China.
Qualifications
Advanced degree (PhD preferred) in Analytical Chemistry, Biochemistry, or related field. At least 10+ years of laboratory experience in an industrial setting. Extensive experience in analytical development for biologics, including method validation and tech transfer.
Proven experience supporting co-development alliances and global technology transfers. Strong leadership skills with a proven track record of managing multidisciplinary teams. Knowledge of GMP regulations and global regulatory expectations.
Experience: Extensive experience antibody or ADC drug development. Deep understanding of the design, development, optimization, and tech transfer of antibody or ADC manufacturing processes. Expertise in developing, optimizing, troubleshooting, and tech transferring analytical methods for antibodies or ADCs.
Proficiency in analyzing and interpreting complex datasets from multiple methodologies. Expertise in method robustness assessment, validation, and testing. Demonstrated experience in cross-functional and functional leadership roles with strong collaboration and stakeholder relationship management skills. Proficient in drafting, reviewing, approving, and supporting regulatory filings and responses. Comprehensive knowledge of ICH and FDA regulations and guidance for biologics and ADCs.
Language Skills: Proficiency in reading and writing Mandarin Chinese is required to effectively collaborate with the Chengdu facility and global partners.
Pay
The expected base salary range for this position is $190,000 - $280,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
Benefits
100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years.
15 PTO days per year, sick leave, plus 11 paid holidays.
About the Role
SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor.