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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 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
Supervisory Responsibility
- This position supervises Manager I/II, Scientist I/II/III, Analyst I/II/III, and other Operations staff.
- This position will supervise up to 40 employees.
- Ability to guide and direct others in successful outcomes and provide mentorship
- Performance reviews/evaluations and career development of staff
Supervision Received
- Infrequent supervision and instructions
- Frequently exercises discretionary authority
Working Environment
- Primarily laboratory environment
- Exposure to biological fluids with potential exposure to infectious organisms
- Rare exposure to skin and lung irritants, toxic materials, and hazardous waste
- Personal protective equipment required, such as protective eyewear, garments, and gloves
- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
Physical Demands
- Ability to work in an upright and/or stationary position for up to eight (8) hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment
- Frequent mobility needed
- Frequent crouching, stooping, with frequent bending and twisting of upper body and neck
- Light to moderate lifting and carrying (or otherwise moves) objects, including laboratory equipment, laboratory supplies, and laptop computer, with a maximum lift of 20 pounds
- Ability to access and use a variety of computer software
- Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
- Frequently interacts with others to obtain or relate information to diverse groups
- Requires multiple periods of intense concentration
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
- Ability to perform under stress and multi-task
- Regular and consistent attendance
Position Type and Expected Hours of Work
- This is a full-time position
- Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
- Occasional weekend, holiday, and evening work required
$190,000 - $208,000 a year
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
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