BioAgilytix
Location: San Diego,CA, USA
Date: 2024-11-18T12:01:19Z
Job Description:
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.Essential ResponsibilitiesServe as Bioanalytical Project Manager (BPM)/Principal Investigator (PI) on a projectMay prepare and submit deviationsManage project timelines/schedulingManage budget and revenue for projectsCommunicate with clientTrain analysts/junior scientistsDevelop assay independentlyAbility to assist with definition of project scope and proposal preparation (SME)Prepare and review scientific training materials (eg BAL University)Set up studies in LIMS systemServe as lead scientist on assay dev projectServe as lead scientist on validation or qualificationPresent data to clientsIndependently write plans and reports for validation or qualificationResponsible for prompt identification and notification of deviationsPerform assays according to GLP guidance or SOPsFollow GLP guidance/SOPs for validation or for qualification of assaysRun assays independently; (biomarker, cell-based, immunogenicity, immuno-, enzymatic, or LC/MS/MS)Prepare worksheets independentlyAnalyze & interpret dataPrepare summary tablesPeer review raw dataPrepare reagentsTroubleshoot assaysDesign assay runs independentlyWrite SOPsWrite plans/reports for sample analysisOrder and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needsAdditional ResponsibilitiesOther duties as neededMinimum Preferred Qualifications: Education/ExperienceBachelor's degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than twelve (12) years' experience in a scientific laboratory environment; orMaster's degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than ten (10) years' experience in a scientific laboratory environment; orPhD in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than eight (8) years' experience in a scientific laboratory environmentMinimum Preferred Qualifications: SkillsAbility to develop immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen or, the ability to oversee the following study types: protein binding, CYP inhibition, CYP induction, or CYP phenotyping or ability to oversee and develop chromatographic assays using HPLC or LC/MS/MSMust work effectively within team to meet objectives under time constraintsAbility to take direction well and multi-taskDetail oriented and highly organizedExcellent oral and written communication skillsProficient 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 IA role: Experience with execution of PK/biomarker/ADA assaysCB role: Experience with execution of potency/NAb assaysBC role: Experience with execution of LC/MS/MS assaysDMPK role: Experience with execution of ADME assaysSupervisory ResponsibilityThis position supervises Analyst I/II/III and Scientist I/IISupervision 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 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 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 requiredOccasional travel required$130,000 - $140,000 a yearBENEFITS AND OTHER PERKSMedical 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 ProgramCOMMITMENT TO EQUAL OPPORTUNITYBioAgilytix 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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