Method Development/Validation Dose Formulation Analysis Scientist

Inotiv•West Lafayette, IN

1d•Onsite

About The Position

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. Inotiv is a growing contemporary drug discovery and development company focused on drug discovery and development solutions that impact global health and well-being. As a leading contract research organization (CRO), Inotiv supports discovery and nonclinical development through investigational new drug (IND) and beyond, leveraging deep expertise and scientific capabilities to increase efficiency, improve data, and reduce the cost of bringing new drugs to market. The company provides critical research models and related services to help researchers realize the full potential of their R&D projects, aiming to build a healthier and safer world.

Requirements

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 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

Responsibilities

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 to requirements
Lead projects
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