Requirements: Minimum of a Masters Degree in Chemistry, with 5 years previous experience in pharmaceutical method development/validation required. Preferred Ph.D. analytical chemist with 1 to 5 years of experience in method development (HPLC, GC)
· Develop and validate both compendial and noncompendial analytical methods for raw materials, inprocess materials, final product and stability testing.
· Conduct product degradation studies and maintain the in-house reference standard qualification system
· Provide technical support for the Quality Control and R&D laboratories, including instrument troubleshooting, routine maintenance and training.
· Operate, maintain and calibrate analytical instrumentation including HPLC, GC, UV, IR and TOC.
· Write and follow analytical test methods, validation protocols and reports in compliance with current regulatory requirements and industry standards.
· Characterize noncompendial standard materials through a variety of testing to establish assay and purity.
· Maintain, follow, and update Standard Operating Procedures for the Quality Control laboratory.
· Maintains accurate records.
· Schedule method development and validation activities.
· Work with R&D and QC to ensure robust methods are developed and validated that serve the needs of both groups for process development as well as routines QC analysis.
· Participate in technical meetings with customers to address analytical development issues.
Other duties may be assigned as required.