POSITION OBJECTIVE: Responsible for method development, method transfer, method verification, and co-validation of compendial and non-compendial analytical methods. Provide technical support to multiple departments and groups.
Essential Job Functions/Responsibilities
· Direct the daily tasks for laboratory technical staff with training, operations of equipment, laboratory techniques, and GMP compliance.
· Manage external CRO and CMO teams on laboratory related projects.
· Oversee and participate in method development, method transfer, method verification, and co-validation of analytical procedures within the Manufacturing Sciences Laboratory.
· Act as liaison between Manufacturing Sciences and the QC chemistry laboratory for the transfer and implementation of new testing procedures.
· Identify and investigate complex problems occurring in all Athenex Analytical laboratories and provide technical support in solving the problems.
· Write, review, and approve documentation such as protocols, test methods, SOPs, etc.
· Provide support for IND and NDA filings as an SME.
· Serve as a member of Athenex multidisciplinary project teams.
· Assist and work with Quality Management to complete Laboratory Investigation Reports.
· Provide technical troubleshooting support, knowledge transfer and training/coaching to Quality Control, Research and Development, and Clinical Sciences.
· To be proficient in the use of analytical techniques and work independently to perform complex chemical and physical analyses on all products and materials.
· Execute Good Manufacturing Practices (GMP) in a pharmaceutical laboratory environment.
· Produce analytical work and maintain consistent and accurate documentation skills in accordance with all applicable Standard Operating Procedures and approved analytical methods.
· Practice Strong technical writing skills, able to maintain laboratory notebooks, and write clear, concise validation reports. Assist in writing of department policies, procedures and specifications.
Required Education & Qualifications
· Bachelor’s degree in Chemistry or related discipline required
· 7-10 years of experience in a chemistry laboratory environment required
· Demonstrated Project Management Skill and Experience
· Expert working knowledge of HPLC method development preferred
· Able to communicate in a professional manner and interact with multiple departments on a daily basis
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.