Director / Senior Director of Analytical

Director / Senior Director Of Analytical

Located in Redmond WA, 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.

The Director / Senior Director of Analytical will lead the Analytical teams, working collaboratively with the Director of Process Development, Head of Cell Science in Redmond, WA and CMC leads in Chengdu. This role is responsible for driving analytical strategy, method development, and release assay designs to support early-stage biologics development and GMP manufacturing. The role is responsible for integration of analytical workflows with upstream and downstream processes and is accountable for analytical method transfer to the company's GMP manufacturing site in China.

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. Partner with QC teams in Chengdu to ensure successful product release, characterization, and scaling.
• Collaboration & Integration : 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

Experience

The hiring pay range for this position is $180,000 - $280,000 per year based on skills, education, and experience relevant to the role.

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).

SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.