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 Manager II 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 fairlyPresent 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 chemistry, biochemistry, biotechnology, or related field with not less than twelve (12) years’ experience in a scientific laboratory environment; orMaster’s degree in chemistry, biochemistry, biotechnology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; orPhD in chemistry, biochemistry, biotechnology, or related field with not less than eight (8) 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/IDWrite and execute validation and sample analysis plansReview and evaluate PK/TK data and ISR results to identify trends and outliersPlan and execute cross-site validations for projects transferring between sitesMust work effectively within team to meet objectives under time constraintsAbility to make sound judgments quickly and confidentlyAbility to take direction well and multi-taskDetail oriented and highly organizedExcellent oral skills, communicating clearly in meetings or presentations.Excellent written communication skills, writing clear reports, emails, or policiesProficient in the use of MS Excel and WordDemonstrated 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, and Manager IAbility to guide and direct others in successful outcomes and provide mentorshipPerformance reviews/evaluations and career development of staff
Supervision Received
Infrequent supervision and instructionsFrequently exercises discretionary authority
Working Environment
Primarily 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 cabinets
Physical Demands
Ability 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 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 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 attendance
Position Type and Expected Hours of Work
This 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
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.
