POSITION OBJECTIVE: Oversees the Quality Control organization for Athenex Pharma Solutions, including: raw material testing, finished good testing, stability testing, assay development and assay transfer. Maintains rigorous quality mindset and advocates strict adherence to compliance practices within the testing labs and facility. Possesses strong technical expertise in chromatography, assay development, USP compendial testing, and current Good Manufacturing Practice (cGMP) for in-process, raw materials and product quality testing. Works closely with the Analytical Research and Development group to receive and validate of new assays and technologies. Provides QC organization with strategic vision, leadership, capacity planning, metrics development and continuous improvement.
Essential Job Functions/Responsibilities
- Oversees Managers from Raw Material, Finished Good, Microbiology, and Stability departments.
- Oversees Quality Control activities at all Athenex FDA Registered Drug Establishments.
- Provides technical expertise to investigations and key projects.
- Ensures quality control testing is scheduled and performed.
- Develops and Manages to Operational and Performance Metrics.
- Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards.
- Recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems.
- Conducts employee performance appraisals in a timely and objective manner.
- May act as Study Director for assigned assays and assumes all associated responsibilities.
- Interacts with other functional groups to discuss project planning and testing issues.
- Works with the Analytical Research and Development group to provide strong in-house guidance on science and technology.
- Works closely with CMC group on Regulatory Submissions.
- Interacts with internal staff to identify assays requiring further improvement or development.
- Assures that laboratory personnel are following all company SOPs and safety rules.
- Prepares and revises technical documents (Laboratory Protocols, Change Controls, Laboratory investigations, CAPAs, SOPs, etc.).
- Prepares quotes and budgets for the QC Department.
- Interface with all regulatory agencies and customer audit representatives.
Required Education & Qualifications
· A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. M.S. or M.B.A. is a plus.
· A minimum of 5 years in a Laboratory Management role is required.
· Strong technical background in HPLC/UPLC is required.
· Experience with oral solid pharmaceutical dosage and/or sterile injectables is preferred.
· Must have a minimum of 5 years of experience in cGMP assurance in both national and international markets (specifically, the US and EU).
· Experience with cGMP 21 CFR 210/211 Quality Systems.
· Direct and positive experience in communicating with Regulatory Authorities, customers, and executive management.
· Experience in CAPA, investigations, root cause analysis.
· Experience with method development and implementation per USP / EU standards.
· Experience in implementing training and complaint programs.
· Lean Six Sigma experience is a plus.
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.