Formulations Specialist

Job Summary

Independently perform, prepare and/or oversee the preparation of vehicles and complex test article formulations for use in a variety of toxicology study designs.  Assist in the accurate study preparation and oversight of formulation preparation procedures and ensure conduct according to Standard Operating Procedures and GLPs.

Long Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:   •    Copy  Formulation Batch Records for routine studies and facility procedures. •    Prepare Dispense definitions for routine studies and facility preparations. •    Perform and/or oversee the preparation of test article/substance dosage solution/suspension(s), ensure preparation procedures and calculations are standardized, performed consistently and recorded correctly by the technical personnel. •    Ensure accurate recording of test article and vehicles/reagents to maintain accountability and inventory. Monitor use on study and ensure accurate usage and inventory throughout the course of studies. •    Calibrate, operate and maintain laboratory equipment.  •    Collect, record data and perform all tasks in accordance with Good Laboratory Practices Regulations (GLPs), study protocols and Standard Operating Procedures (SOPs). •    Perform daily verification of formulation calculations and data quality control checks. Assists in ensuring correct test article calculations for studies, appropriate batch sizes are prepared and study supplies are monitored. •    Perform review of study books and electronic data. •    Interact with Study Directors, Study Coordinators, Data Management and other operational staff in the planning and conduct of studies. •    Perform daily dispensary activities, meeting study timelines according to the daily schedule •    Assist in overseeing client visits on assigned studies. •    Prepare and/or review  packing lists for the shipment of test articles and samples to the sponsor and/or analytical laboratory.  •    Ensure accurate inventory and management of test article and study reagents for assigned studies. •    Independently respond to Quality Assurance audits of preparation procedures and facility audits and execute corrective actions  •    Conduct laboratory investigations into out of specification formulations. •    Assist in training new personnel. •    Recommend, participate and/or lead process improvement projects. •    Perform other related duties as assigned.

Job Qualifications

QUALIFICATIONS: •    Education:  Bachelor’ degree (B.S.) preferred. •    Experience:  Minimum 4 years related laboratory experience required •    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. •    Certification/Licensure:  Must have valid, state-issued, driver’s license. •    Other:  Must be detail-oriented and have good verbal and written communication skills. Must have good computer skills and experience with Microsoft Office software.

PHYSICAL DEMANDS: •    Employees must be able to lift, move, manipulate, and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or supplies. •    Must be able to perform procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards. •    Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.   •    Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.