Position Overview

This position requires the ability to independently perform complex laboratory techniques in a GMP environment. Some method development work is required.

Specific Responsibilities

• Follows all applicable regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function
• Maintains data integrity and employs good documentation practices when performing experiments
• Compares laboratory data against specifications and trend data where applicable to determine if results meet requirements.
• With guidance, propose applicable specifications based on data obtained in support of certain programs
• Stays current on all applicable SOP, safety, human resources, and annual quality related training
• Adheres to all internal quality standards while having the mindset of process improvement and reduction of laboratory errors
• Ensures proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation
• Ensures accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations
• Directs and assists in laboratory personnel training when required
• Under general supervision, authors standard operating procedures, analytical testing procedures, final submission ready documents, and creates document templates for use by junior staff members
• Independently performs routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for new chemical entities and/or drug products
• Under general supervision, evaluates methods of analysis for chemical entities and drug product formulations and provides solutions and recommendations for ensuring robust methods are developed and/or validated
• Interprets data and make recommendations to management for improvement or potential concerns
• Creates report templates and/or enter data into established reports/templates or software based systems
• May serve as a technical liaison between functional groups such as QA and metrology
• Reviews routine and complex laboratory experiments for accuracy and provide guidance to junior staff to ensure future compliance
• Provides input on scheduling of tasks and adhere to assignments and executes with leadership under stated timelines
• Proficient in the use of Empower (performs supervisory sign-off for electronic reports) and other software based systems
• Performs other duties related to the position when required by laboratory management

Qualifications

• BS or BA degree in Chemistry (or equivalent degree such as Pharmaceutical Sciences) with three years of professional experience in pharmaceutical analytical chemistry, or
• BS or BA degree Biology with five years of professional experience in pharmaceutical analytical chemistry, or
• Master