Manager I - LC/MS Bioanalytical

BioAgilytix•San Diego, CA

1d•$145,000 - $160,000•Onsite

About The Position

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 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.

Requirements

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
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

Nice To Haves

Ability to guide and direct others in successful outcomes and provide mentorship
Performance reviews/evaluations and career development of staff

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.