Director of Bioanalytical Chemistry

The Director of Bioanalytical Chemistry is a Senior Leadership role responsible for bioanalytical strategies, laboratory operations, and regulatory compliance for drug and combination product development. The duties include managing teams of scientists, designing and validating analytical methods, analyzing complex data from biological samples, and ensuring compliance with standards like GLP/GCP for preclinical and clinical studies. This role requires expertise in techniques such as LC-MS/MS, ELISA, and biomarker analysis, and involves significant cross-functional collaboration.

The individual is responsible for ensuring CBSET maintains its outstanding and cutting-edge services and delivers high-quality results and will play a leadership role in setting plans for strategic growth of the business. Key management oversight responsibilities in this role include laboratory operations and workflow, compliance with Good Laboratory Practices (GLPs), and hiring, management and training oversight of bioanalytical laboratory staff. Advanced degree and expertise in the field of bioanalytical and/or preclinical labs is desirable, and minimum of 5 years of successful management and business leadership.

Excellence in communication skills, professionalism, and team building a must.

Salary range is $150,000 – $225,000/year. (Please note, salaries vary within the range based on factors including, but not limited to, experience, skills, education, and certifications.)

• Lead and manage teams of bioanalytical scientists and support staff, guiding their work and contributing to strategic decisions.
• Oversee the design, development, and validation of robust bioanalytical assays, including pharmacokinetics (PK), anti-drug antibodies (ADA), and biomarker methods, using various platforms such as LC-MS/MS and immunoassays (ELISA, MSD, etc.).
• Plan and execute bioanalytical studies to support drug development, including pharmacokinetic (PK), pharmacodynamic (PD), and biomarker analysis.
• Review, interpret, and present complex data to internal and external stakeholders, ensuring scientific accuracy and actionable insights.
• Ensure all bioanalytical activities and data meet regulatory standards and guidelines, such as GLP/GCP.
• Work with cross-functional teams, including project managers, regulatory affairs, and external partners, to advance drug development programs.
• Build, lead, and mentor a high-performing team of scientists and technical staff, fostering a collaborative and innovative work environment.
• Directly oversee Bioanalytical Managers and Supervisors, with indirect oversight of technical and scientific staff.
• Develop staffing plans and laboratory department budgets to support strategic growth.
• Work interdepartmentally with other directors and staff to maintain and improve processes and consistency and meet internal timelines.
• Determine laboratory designs, key equipment purchases, and capital investments to enable growth targets.
• Provide bioanalytical input into research and development plans and contribute to the overall strategy for product pipelines.
• Maintain and expand client relationships.
• Manage the planning, execution, and interpretation of bioanalytical studies, troubleshooting analytical challenges and ensuring data integrity and quality control.
• Act as the primary scientific liaison, collaborating closely with cross-functional teams and external partners (CROs, external vendors) to ensure alignment with project goals.
• Ensure compliance with Good Laboratory Practice (GLP) standards, including in laboratory operations, safety, record-keeping and archiving, and with departmental policies, SOPs, and protocols.
• Perf…