Inotiv
Healthcare
MethodDevelopment/ValidationDoseFormulationAnalysisScientist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Method Development/Validation Dose Formulation Analysis Scientist at Inotiv. Skills: Method Development, Validation, Dose Formulation Analysis, Analytical Methods, HPLC, Detection Methods (MS, CAD, RI, UV/Vis), FDA regulations, HIPAA regulations. developing, validating, and applying analytical methods to determine the concentration, stability, and homogeneity of test substances in various matrices (dose formulations) to support preclinical and clinical trials. ensure laboratory activities adhere”
What You'll Achieve.
support preclinical and clinical trials
Industry & Context.
Ability to adhere to all safety regulations and procedures
What They're Looking For.
Must Have
comprehensive technical knowledge which includes, but is not limited to, the in-depth understanding of chemistry, instrumentation and laboratory operations, Ability to develop HPLC methods, Experience with various detection methods (MS, CAD, RI, UV/Vis), Knowledge of FDA regulations, Good organizational skills, Ability to use a computer to compile and maintain databases for records and to write technical reports, Know and understand applicable national and state regulations, with the ability to apply these practices daily, Working knowledge of and ability to adhere HIPAA regulations, A working knowledge and awareness of general laboratory procedures., Ability to work independently, Good written and oral communication skills: must be able to manage people on a daily basis, Ability to adhere to all safety regulations and procedures, Ability to document analytical results, Ability to interact constructively with clients, Demonstrates effective leadership skills, Ph. D. in a specifically related science such as chemistry, toxicology, or pharmacology., M. S. with at least 5 years of direct work experience., B. S. with at least 8 years of direct work experience., Equivalent combination of related education and required work experience will be considered.
What You'll Do.
and applying analytical methods to determine the concentration
and homogeneity of test substances in various matrices (dose formulations) to support preclinical and clinical trials
ensure laboratory activities adhere to requirements
provide technical leadership for junior staff
Maintains and improves client relations
Develops and validates analytical methods
Operate laboratory instrumentation
Write technical protocols and reports
Facilitates and trains laboratory and project management scientists
Provides support and effective communication with Business Development activities
Directs Laboratory Technicians
Develops and maintains records to comply with appropriate regulatory requirements
Maintain a clean work environment and perform equipment repair as needed
May assume the following roles: special projects
principal investigator
Review and maintain data associated with the study
Prepare periodic progress reports for management
Maintain confidential information
Interact with the community
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Facilitates and trains laboratory and project management scientists; Provides support and effective communication with Business Development activities; Directs Laboratory Technicians, Analysts, and Project Managers; Interact with the community, employees, and clients; Ability to interact constructively with clients
Communication Scope
Good written and oral communication skills; Provides support and effective communication with Business Development activities; Interact with the community, employees, and clients; Ability to interact constructively with clients
Process & Methodology
lead projects, study manager, principal investigator, project manager
Full Job Description
The MD/MV Dose Formulation Scientist is responsible for developing, validating, and applying analytical methods to determine the concentration, stability, and homogeneity of test substances in various matrices (dose formulations) to support preclinical and clinical trials. They ensure laboratory activities adhere to requirements, lead projects, and provide technical leadership for junior staff. * Maintains and improves client relations * Develops and validates analytical methods * Operate laboratory instrumentation * Write technical protocols and reports * Facilitates and trains laboratory and project management scientists * Provides support and effective communication with Business Development activities * Directs Laboratory Technicians, Analysts, and Project Managers * Develops and maintains records to comply with appropriate regulatory requirements * Maintain a clean work environment and perform equipment repair as needed * May assume the following roles: special projects, study manager, principal investigator, project manager, marketing, technical support, method development, and R&D discovery * Review and maintain data associated with the study * Prepare periodic progress reports for management * Maintain confidential information * Interact with the community, employees, and clients * Perform other duties as assigned * Must possess comprehensive technical knowledge which includes, but is not limited to, the in-depth understanding of chemistry, instrumentation and laboratory operations * Ability to develop HPLC methods * Experience with various detection methods (MS, CAD, RI, UV/Vis) * Knowledge of FDA regulations * Good organizational skills * Ability to use a computer to compile and maintain databases for records and to write technical reports * Know and understand applicable national and state regulations, with the ability to apply these practices daily * Working knowledge of and ability to adhere HIPAA regulations * A working knowledge and awareness of gener
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