About this role
The Scientist II will support the bioanalytical Method Development and Validation Team and is responsible for the overall scientific and operational management of client bioanalytical projects supporting a variety of studies simultaneously. This role requires knowledge of method validation principles and communication skills required to transfer methods to analytical team. The Scientist II role supports client projects with limited supervision and requires project leadership and direct client communication.
Research Technician II Duties Include but are not Limited to the Following:
Works effectively as a member of a team, under minimum direction, to achieve client and business deadlines Understands and follows all procedures and processes required for work performed under Regulatory Compliance (i.e. GxP, FDA/GLP and GCP, OECD, CLIA, etc.) and attends annual GLP trainingAssists the development, validation and transfer of immunoassays and bioanalytical methods with limited direct supervision (RIA, EIA, Flow Cytometry, Cell-Based Assays)Provides contracted method development and validation services consistently with delivery on time and high quality. Characterizes antibodies and performs reagent qualification as applicableConducts evaluation of manufactured products and develops fit-for-purpose assaysCommunicates project updates to internal and external clients with limited supervisionProvides technical documentation in the form of validation plans, reports, deviation reports, test methods and tables with limited supervisionReviews validation data, validation plans and reports and provides technical leadership and constructive feedback to team membersHas the ability to organize daily workflow of the development and validation schedule in lab and consistently meets validation timelines.Ability to develop a method with assistance from Scientific DirectorProvides technical leadership, mentoring and training to junior staffProvides troubleshooting, root cause analysis and assistance with method designComplies with internal and customer SOP’s as required in training program; maintains an up to date training fileApplies use of IT systems (ERP, LIMS, etc.) as required With minimum guidance, designs, plans and performs/manages routine and non-routine projectsApplies GMP/GLP in all areas of responsibility, as appropriate and understands and follows all written procedures that apply to the function of the positionOwns the accountability and responsibility for delivering to client needs and timelinesProvides cross-functional support to other departments as requiredAdjusts work hours as needed to meet client deadlinesAdheres to site environmental health and safety (EHS) requirementsDemonstrates and promotes the company visionRegular attendance and punctualityPerforms other duties as assigned Basic Minimum Education & Experience Qualifications:
B.A. or B.S. with minimum 5-7 years method development and validation experienceM.A. with minimum 3-5 years method development and validation experiencePh.D. with minimum 2-4 years method development and validation experienceBasic Minimum Work Requirements:
Previous Pharma and /or CRO, Clinical Laboratory experience required.Experience in designing and performing ligand binding assays.Experience with operational process improvement programs.Experience with direct client contact in industryAuthorization to work in the United States indefinitely without restriction or sponsorship.The Ideal Candidate Possesses the Following:
Excellent communication and interpersonal skillsAbility to perform statistical analysis and data interpretationComputer proficiency in MS Word, Excel and instrumentation software.Proven ability to compile data and create data reportsAbility to work in a laboratory setting, meeting the physical requirements of laboratory experiments.Ability to read, write and interpret documents such as standard operating procedures and technical reportsAbility to solve practical problems and troubleshoot assaysAbility to multitask with good time managementOrganizational skills to manage multiple prioritiesProven ability to effectively communicate orally and in writing to coworkers, supervisors, and clients.Have a positive attitude and genuine interest in the drug discovery and developmental process and impact to patient health Position is full-time working Monday - Friday, 8:00am - 4:30pm, and additional hours as needed. Candidates currently living within a commutable distance to Lenexa, KS are encouraged to apply.
Location: 15 Research Park Dr., St. Charles, MO 63304Excellent full-time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.