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.
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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 ResponsibilitiesLead, mentor, and develop Bioanalytical Chemistry and Formulation Chemistry teams (up to 40 staff) to enhance collaboration, productivity, and on-time project deliveryDevelop the Bioanalytical Chemistry and Formulation Chemistry Leadership into a team that shares resources, increases productivity and reduces missed client deadlinesTrain leadership to manage deviations, failed runs, and SOP errorsOversee 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 regulationsAdditional ResponsibilitiesOther duties as neededMinimum Preferred Qualifications: Education/ExperienceBachelor's degree in chemistry, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 18 years' experience in a scientific laboratory environment; orMaster's degree in chemistry, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 16 years' experience in a scientific laboratory environment; orPhD in chemistry, molecular biology, biochemistry, immunology, biotechnology, or related field with no less than 14 years' experience in a scientific laboratory environmentMinimum Preferred Qualifications: SkillsKnowledge of USFDA, OECD and MHLW GLP regulatory requirements; proficient with LC/MS/MS, HPLC, ELISA systems and all laboratory equipmentDemonstrated experience in a supervisory role leading teams to meet objectives while adapting to competing demands, tight deadlines, and a fast-paced environmentRequires the ability to communicate clearly in both written and oral formsStrong 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 stakeholdersBe 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 skillsAbility to design robust DOE studies to optimize formulationsAbility to organize, manage and operate a laboratory that conducts multiple studies simultaneously as well as participate in the negotiation of contractsRequires a clear and concise understanding of drug discovery and developmentDemonstrate 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 programsSupervisory ResponsibilityThis 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 mentorshipPerformance reviews/evaluations and career development of staffSupervision ReceivedInfrequent supervision and instructionsFrequently exercises discretionary authorityWorking EnvironmentPrimarily laboratory environmentExposure to biological fluids with potential exposure to infectious organismsRare exposure to skin and lung irritants, toxic materials, and hazardous wastePersonal protective equipment required, such as protective eyewear, garments, and glovesRoutinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical DemandsAbility to work in an upright and/or stationary position for up to eight (8) hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentFrequent mobility neededFrequent crouching, stooping, with frequent bending and twisting of upper body and neckLight to moderate lifting and carrying (or otherwise moves) objects, including laboratory equipment, laboratory supplies, and laptop computer, with a maximum lift of 20 poundsAbility to access and use a variety of computer softwareAbility 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 sentencesFrequently interacts with others to obtain or relate information to diverse groupsRequires multiple periods of intense concentrationPerforms a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrenceAbility to perform under stress and multi-taskRegular and consistent attendancePosition Type and Expected Hours of WorkThis is a full-time positionSome flexibility in hours is allowed, but the employee must be available during the "core" work hours as published in the BioAgilytix Employee HandbookOccasional 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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