Director, Bioanalytical/Formulation Chemistry

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
The Director, Bioanalytical / Formulation Chemistry oversees the Bioanalytical Chemistry and Formulation Chemistry departments in our San Diego lab, ensuring full compliance with all laboratory SOPs and regulatory requirements. We’re seeking an experienced manager to lead these teams, supervising up to 40 employees. This role is accountable for daily operations, regulatory compliance, and scientific quality, while mentoring departmental leaders to promote effective resource sharing, balanced workloads, and on-time project delivery.

Essential Responsibilities

• Lead, mentor, and develop Bioanalytical Chemistry and Formulation Chemistry teams (up to 40 staff) to enhance collaboration, productivity, and on-time project delivery
• Develop the Bioanalytical Chemistry and Formulation Chemistry Leadership into a team that shares resources, increases productivity and reduces missed client deadlines
• Train leadership to manage deviations, failed runs, and SOP errors
• Oversee daily operations, scheduling, documentation, and compliance with GLP (USFDA, OECD, MHLW) standards.
• Train and develop department leadership to manage deviations, SOP errors, workload distribution, and financial accountability.
• Supervise scientists’ work, assess analytical results, troubleshoot issues, and ensure timely completion of studies.
• Serve as Principal Investigator or Study Director for GLP/validation projects, reviewing data, methods, and reports.
• Collaborate with Project Managers to discuss new projects, prepare and review study exhibits, and maintain pricing consistency.
• Maintain client communication through weekly updates, meetings, and addressing issues as needed.
• Attend and contribute to lab, project management, and company leadership meetings.
• Support hiring, onboarding, performance reviews, and ongoing training for department staff.
• Develop and maintain SOPs in compliance with regulatory requirements.
• Drive innovation through evaluation and implementation of new analytical approaches, technologies, and instrumentation.
• Maintains documentation and compliance standards with adherence to USFDA, OECD, and MHLW Good Laboratory Practices regulations

Additional Responsibilities

• Other duties as needed

Minimum Preferred Qualifications: Education/Experience

• Bachelor’s degree in chemistry, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 18 years’ experience in a scientific laboratory environment; or
• Master’s degree in chemistry, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 16 years’ experience in a scientific laboratory environment; or
• PhD in chemistry, molecular biology, biochemistry, immunology, biotechnology, or related field with no less than 14 years’ experience in a scientific laboratory environment

Minimum Preferred Qualifications: Skills

• Knowledge of USFDA, OECD and MHLW GLP regulatory requirements; proficient with LC/MS/MS, HPLC, ELISA systems and all laboratory equipment
• Demonstrated experience in a supervisory role leading teams to meet objectives while adapting to competing demands, tight deadlines, and a fast-paced environment
• Requires the ability to communicate clearly in both written and oral forms
• Strong interpersonal skills with the ability to work with all levels of management and employees; ability to gain credibility, provide effective customer service, and foster positive working relationships with internal and external stakeholders
• Be familiar with laboratory environment and knowledge of relevant laboratory techniques, complex formulation types (e.g., microemulsions, controlled-release systems, nanocarriers) and able to interface with all levels of management, and good communication skills
• Ability to design robust DOE studies to optimize formulations
• Ability to organize, manage and operate a laboratory that conducts multiple studies simultaneously as well as participate in the negotiation of contracts
• Requires a clear and concise understanding of drug discovery and develop