POSITION OBJECTIVE: Conduct analytical research and method development at an independent level using various chemistry and instrumentation techniques. Execute experimental studies and protocols in a cGMP compliant manner. Perform pharmaceutical method development and participate in manufacturing process development. Lead team members in tech transfer initiatives, protocol and report generation, and method validations.
Essential Job Functions/Responsibilities
· Perform method development and validation using analytical instrumentation including HPLC, UPLC, GC, UV/VIS, Mass Spectrometer, and dissolution apparatus.
· Facilitate tech transfer to other departments, laboratories, and cross-functional groups.
· Proficient in independently performing complex chemical and physical analyses across products and materials.
· Experience in developing chemistry and/or physical methods, and familiar with ICH and USP guidelines for analytical method validation.
· Ability to perform in an applied research environment and adapt to changing project priorities and acquire new technical skills and knowledge.
· Manage outsourced analytical projects with external CROs or CMOs.
· Assist or lead in writing of technical protocols and reports, contribute to experimental design with justifications, and developing specifications. Support cGMP stability studies and contribute in elucidating typical degradation profiles under known ICH stress conditions.
· Work as an effective team member to meet departmental objectives, including sharing knowledge with team members and across the laboratory.
· Provide technical troubleshooting support, knowledge transfer and training/coaching to other lab members and other technical departments.
· Execute Good Manufacturing Practices (GMP) in a pharmaceutical laboratory environment.
· Produce analytical work and maintain consistent and accurate documentation skills per Good Documentation Practice (GDP) in accordance with all applicable Standard Operating Procedures and approved analytical methods.
· Maintain a safe and healthy working environment. Instruct and enforce compliance with established safe work practices and procedures.
· Perform general maintenance and calibration of laboratory equipment
· Can work independently with little supervision.
Required Education & Qualifications
· M.S. Degree or higher degree in Chemistry, Engineering or related discipline. Preferred 5+ years in a R&D environment.
· Minimum B.S. Degree in Chemistry or related discipline or minimum 7 years in a chemistry or R&D laboratory environment.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.