POSITION OBJECTIVE: Conduct analytical research at an independent level using various chemistry, physical and instrumentation techniques. Independently execute experimental studies and analytical method development and summarize data. Perform pharmaceutical product development and participate in manufacturing process development, including physical and chemical compatibility, scale up, and facilitate tech transfer.
Essential Job Functions/Responsibilities
- Perform analytical and preliminary process development and facilitate tech transfer to other departments and cross-functional groups, including QC and Engineering.
- Proficient in independently performing complex chemical and physical analyses across products and materials. Ability to evaluate processing parameter impact on achieving target product profile.
- Experience in developing chromatographic, 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.
- Assist or lead in writing of technical protocols and reports, contribute to experimental design with justifications and developing specifications. Support R&D stability studies and contribute in elucidating typical degradation profiles such as degradation rate determination under various conditions including pH, oxygen, buffer, temperature, light and physical interactions.
- 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. Participate in experimental design.
- 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.
- Promote and maintain a safe and healthy working environment in the work area. Instruct and enforce compliance with established safe work practices and procedures.
- Perform general maintenance and calibration of laboratory equipment. Develop and execute new equipment protocols.
- Can work independently with little supervision.
Required Education & Qualifications
- Master of Science degree or higher degree in Chemistry, Engineering or related discipline.
- 5+ years of similar work experience in a R&D environment.
- Minimum of Bachelor of Science degree in Chemistry or related discipline with a minimum of 7 years in a chemistry or R&D laboratory environment.
- Experience in method development applicable to topical products preferred.
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.