Address
Form of work- Manage and lead analytical testing activities, including IPCs, cleaning verification, stability studies, release testing of incoming materials, intermediates, drug substance and drug product using HPLC/UPLC, GC, GC-MS, ICP-OES, pH Meter, KF and LC/MS
- Manage projects associated with pharmaceutical drug substance and drug products
- Perform on-bench analytical activities in accordance with cGMPs regulations
- Coordinate pharmaceutical method development, method validation, and method transfer
- Manage stability programs including evaluation of stability requirements, planning and coordinating stability studies, creating and maintaining stability study plans, performing data analysis, authoring stability reports, and maintaining master stability protocols.
- Design and perform OOS/OOT investigation, and draft CAPA
- Schedule samples for analysis and maintain and enforce the cGMP system applying knowledge of cGMP/GLP and 21 CFR Part 11 procedures
- Maintain documentation relating to analytical release testing and stability packages to ensure high quality standards
- Review and write analytical method validation protocol and reports, technical reports, sections for regulatory filings, and SOPs
- Establish stability program and instrument qualification program
- Approve and issue CoA for drug substance, component, and drug product.
- Must have a Master’s Degree in Chemistry or Chemical Engineering plus 2 years experience in job offered or as Sr. Analyst/Group Leader.
- Require skills and knowledge in cGMP/GLP, HPLC/UPLC, LC/MS, IQ/OP/PQ, CAPA, Method Development.
Anticipated base pay range: $161,096-$163,000
Job Location: San Diego
Submit résumé referencing job code WEH001 to HR, STA Pharmaceuticals US LLC, 6114 Nancy Ridge Drive, Building D, San Diego, CA 92121
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
