Analytical Methods Development Scientist

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)

Responsibilities:

·         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.