The Manager I will lead scientific and operational activities in support of preclinical, clinical, and product release studies for our San Diego lab. This role requires deep expertise in developing chromatographic assays for a variety of modalities in complex biological matrices using HPLC and LC/MS/MS. The ideal candidate will have hands-on and leadership experience overseeing regulated bioanalysis, tissue analysis, protein binding, CYP inhibition/induction, CYP phenotyping, and metabolite profiling/ID. You’ll guide a team of scientists through assay development, validation, and sample analysis under GxP, while also playing a key role in client engagement, project delivery, and cross-functional collaboration.




Essential Responsibilities

Lead team(s) developing and validating bioanalytical assays for support of preclinical, clinical and product release studies.

Motivating team by inspiring employees to achieve goals and aligning employee goals with company strategy by understanding trends and operations, managing departmental budgets and resources, and being the expert in using tools/software relevant to the team.

Work closely with clients to assure successful on time execution of assays, validation, and sample analysis under GxPs.

Prioritizing tasks and managing schedules efficiently.

Meet regularly with lab management to ensure instrument resources and employees are utilized effectively across all teams.

Responsible for team performance and outcomes.

Leading teams through transitions and new initiatives.

Design and execute experiments efficiently and assign tasks appropriately to employees based on skills.

Anticipating and mitigating potential problems and handling disputes calmly and fairly

Present data and posters.

Conduct group team meetings to understand employee’s input and concerns, give constructive and timely feedback, and implement 1:1 meetings with employees on a regular basis.

Hiring and building a team that is knowledgeable and cooperative by investing in the employees’ professional growth, setting goals and evaluating results.

Identify new analytical techniques and technologies and lead their implementation.

Review analytical instrument and equipment calibration, qualification and maintenance records.

Perform statistical analysis.

Write and review reports and prepare SOPs.

Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI) for all assigned clients and studies.

Lead regularly scheduled client meetings to ensure effective communication and manage client expectations.

Provide client satisfaction and great science.

Achieve corporate revenue targets.

Additional Responsibilities

Other duties as needed

Minimum Preferred Qualifications: Education/Experience

Bachelor’s degree in molecular biology, biochemistry, chemistry, immunology, biotechnology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; or

Master’s degree in molecular biology, biochemistry, chemistry, immunology, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment; or

PhD in molecular biology, biochemistry, chemistry, immunology, biotechnology, or related field with no less than six (6) years’ experience in a scientific laboratory environment

Minimum Preferred Qualifications: Skills

Ability to develop chromatographic assays for all modalities in complex biological matrices using HPLC or LC/MS/MS and oversee the following study types: regulated bioanalysis, tissue analysis, protein binding, CYP inhibition, CYP induction, CYP phenotyping or metabolite profiling/ID

Write and execute validation and sample analysis plans

Review and evaluate PK/TK data and ISR results to identify trends and outliers

Plan and execute cross-site validations for projects transferring between sites

Must work effectively within team to meet objectives under time constraints

Ability to make sound judgments quickly and confidently

Ability to take direction well and multi-task

Detail oriented and highly organized

Excellent oral skills, communicating clearly in meetings or presentations.

Excellent written communication skills, writing clear reports, emails, or policies

Proficient in the use of MS Excel and Word

Demonstrated experience serving in a supervisor role and leading teams

Knowledge and application of regulatory guidance to experimental planning and design

Experience working in GxP environments and demonstrated knowledge of GxP regulations  

Supervisory Responsibility

This position supervises Analyst I/II/III & Scientist I/II/III

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