The Analytical Chemist will be responsible for providing leadership in analytical development, validation, API, and Drug Product Stability testing as well as writing CMC sections of applicable regulatory and ANDA submissions. Incumbents will have the responsibility for research experiments and data integrity, as assigned by management. Incumbents will also be responsible for design and implementation of experiments based on an overall description of the intended outcome.
Will serve a primary role in method development and method validation
Conduct literature search and make recommendations for robust analytical methods for product and analytical method development
Screen various methods to implement validate-able analytical methods for new products
Conduct analytical method validation in accordance with ICH Guidelines
Write protocols and reports for method development and validations that are ready for submission to regulatory authorities.
Provide analytical testing and support for all current (parenteral) dosage forms.
Help develop test specifications for new products
Routine testing for release of various materials.
Ensure data integrity, conduct data collection and interpretation, and ensure proper documentation of experimental data. Maintain laboratory notebooks.
Complete assignments requiring an expert knowledge level of techniques? and practices related to the analytical area.
Expertise in GMP laboratory requirements and compliance in accordance with relevant regulations
Manage site inventory. Order laboratory supplies and equipment. Maintain the laboratories and perform other job-related duties as assigned.
Accumulate knowledge and skills to support development and management of research protocols in support of multiple drug discovery efforts.
Achieve business goals, share learning?s, knowledge, and skills and promote cross-functional, teamwork.
Use knowledge and experiences to interpret and properly document experimental data.
Other work as assigned based on the project and company needs.
Education: BS/MS or PhD in Chemistry or related science and minimum of 5 years of related experience.
Prior experience in working with analytical instrumentation such as HPLC, GC, UV/VIS, in a cGMP environment.
Knowledge of ICH and FDA guidelines
Prior chromatographic data acquisition and LIMS System experience
A high degree of computer proficiency and the ability/interest to learn new software programs is required.
Excellent skills in collecting data and accurately maintaining laboratory notebooks required.
Expert level of technical skills.
Flexibility and the ability to work in a fast-paced, team-oriented environment.