Director – Bioanalytical/Formulation Chemistry

Director – Bioanalytical/Formulation Chemistry

Requirements

• 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
• 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 development
• Demonstrate proficiency with data management, analysis, and statistics, etc.
• Understands and applies computer validation principles, computer literate with knowledge of Microsoft Windows, which includes Access, Excel, PowerPoint, and Word programs

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

Preferred Qualifications

• Familiarity with laboratory environment and knowledge of relevant laboratory techniques, complex formulation types (e.g., microemulsions, controlled-release systems, nanocarriers)
• Ability to interface with all levels of management
• Ability to negotiate contracts