Method Development/Validation Dose Formulation Analysis Scientist

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 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.

 

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience.  The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity.  Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.  There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen.  Join us in embracing research and science to impact the health and well-being of people all over the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.