Associate Director/Director, Bioanalytical Laboratory, Redmond

Associate Director/Director, Bioanalytical Laboratory

5 Days Old

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 discover and 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 is seeking an Associate Director or Director of Bioanalytical Laboratory to lead U.S.-based bioanalytical functions supporting our global clinical development programs, with a particular focus on pharmacokinetics (PK) and anti-drug antibody (ADA) analysis for ADCs and other biotherapeutics.
The role, based in Redmond, WA, involves strategic leadership of laboratory operations, scientific oversight of method development and validation, regulatory compliance management, and close collaboration with cross-functional and international teams, especially in China.

This is a high-impact, hands-on leadership position requiring deep scientific expertise, regulatory knowledge, operational excellence, and strong communication skills.

Responsibilities
Strategic & Scientific Leadership

Develop and execute bioanalytical strategies to support preclinical and clinical development of ADCs and other biologics.
Lead development, optimization, and validation of bioanalytical methods (e.g., ELISA, ECLIA, LC-MS/MS, ligand-binding assays) for PK, ADA, and other biomarkers.
Represent Bioanalytical Sciences in regulatory meetings and cross-functional project teams.

Laboratory & Facility Oversight

Oversee day-to-day operations of the Bioanalytical Lab, ensuring compliance with GLP, GCP, ICH, and internal quality standards.
Ensure equipment calibration, qualification, and maintenance are performed according to validated procedures.
Develop and implement SOPs, training curricula, safety protocols, and quality systems to maintain inspection readiness.
Lead preparation and execution of internal audits and inspections by health authorities.

Team & Program Management

Build, lead, and mentor a team of scientists and technical staff; manage performance reviews and career development plans.
Oversee resource allocation, project timelines, and delivery of high-quality data for regulatory and clinical milestones.
Foster a culture of accountability, scientific rigor, and continuous improvement.

Global and Cross-functional Collaboration

Coordinate with global bioanalytical and translational science teams to align platforms, analytical strategies, and data standards.
Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, and other stakeholders to support clinical and regulatory submissions.
Participate in global initiatives to improve harmonization of bioanalytical practices and data reporting.

Regulatory & Quality Responsibilities

Author and review bioanalytical sections of regulatory submissions (e.g., INDs, BLAs, CTAs).
Ensure compliance with international regulatory requirements including FDA, EMA, NMPA, and ICH guidelines (e.g., ICH E6, E14, M10).
Lead or support regulatory inspections, addressing inquiries related to bioanalytical methods, data integrity, and laboratory operations.

Qualifications

Ph.D. in Pharmacology, Biochemistry, Analytical Chemistry, or a related field is preferred.
M.S. with extensive industry experience (12+ years) will also be considered.
Minimum 10 years of industry experience in bioanalytical sciences, with direct involvement in clinical-stage biologics or ADC development.
At least 5 years of leadership experience in a laboratory setting, preferably at the Associate Director level or higher.
Proven expertise in method development, validation, and troubleshooting for PK/ADA assays.
Hands-on experience managing GLP/GCP-compliant labs and implementing CAPA systems.
Working knowledge of data integrity principles (21 CFR Part 11) and equipment/facility qualification.
Strong leadership and team-building abilities; capable of fostering high-performance teams.
In-depth technical expertise in ligand-binding assays, LC-MS/MS, immunoassays, and hybrid methodologies.
Excellent communication skills with demonstrated success in cross-functional and cross-cultural collaborations.
Proficiency in regulatory documentation and audit preparedness.
Ability to work in a dynamic, fast-paced, and mission-driven environment with shifting priorities.

Compensation and Benefits:
The expected base salary range for this position is $150,000 - $230,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role.

SystImmune is a leading and well-funded biotech company with a bright future. 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 including: 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 and MORE.

We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

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

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Location:: Redmond

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