Senior Specialist II, Bioassay - R-101874 - Alachua, FL
Company: National Resilience
Location: Waldo
Posted on: June 25, 2022
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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: Waldo, FL - 32694
Keywords: National Resilience, Gainesville , Senior Specialist II, Bioassay - R-101874 - Alachua, FL, Other , Waldo, Florida
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