Senior Specialist II, Bioassay - R-101874 - Alachua, FL

Company: National Resilience
Location: Brooker
Posted on: June 25, 2022

Job Description:

Responsibilities and Authority:Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.-- - In addition, the Sr Specialist II, Bioassay will be responsible for:Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria.Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP.Performing testing in support of product release, in-process testing, stability and characterization.Preparing SOPs, test methods, protocols and reports.Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change controls, deviations and closure of assigned activities.Interfacing with Quality Assurance, Supply Chain, Manufacturing, Process Development, Validation, Engineering and other operations related functions.*All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.Minimum Education and Experience Requirements for Competency:-- --- --- --- --- --- --- --- --- - BS in a Biological Science, (Biochemistry, Immunology, Molecular Biology, Virology), or related field with a minimum of eight years of experience in CMC CGMP bioassay activities.-- - MS preferred.-- --- --- --- --- --- --- --- --- - Hands-on experience and knowledge of chromatography (HPLC, UPLC) and capillary based applications (capillary electrophoresis, microfluidic electrophoretic separation, capillary based westerns, capillary isoelectric focusing).-- --- --- --- --- --- --- --- --- - Strong analytical problem-solving and troubleshooting skills.Strong leadership and communication skills.This job requires the employee to perform the following physical activities:Stooping, Crouching, Reaching, Walking, Pulling, Standing, Pushing, Lifting, Repetitive motion, Grasping, Hearing, TalkingThis job requires the employee to perform the following type of physical work:Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objectsThis job requires exposure to the following:-- --- --- --- - Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.This job requires following visual acuity requirements:preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.This job requires routine or periodic use of respiratory protection:Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR). PandoLogic. Keywords: Emergency Management Technician, Location: Brooker, FL - 32622

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