Job Title

• Associate Scientist

Position Description

• Creates and leads experiments with minimal supervision from management.  Analyzes or directs the analysis of routine and non-routine samples without supervision and trains or mentors others in routine analyses. Assists in the development of studies and procedures. May be assigned specific area of responsibility within laboratory. Position may supervise nonexempt personnel to achieve above objectives.
  

Position Responsibilities

• Develops, runs/directs, and reports experiments, studies, and projects in support of production, laboratory, or other company group: 
• Gathers sufficient information from all sources to fully understand study and/or customer needs.
• Uses proper study design to effectively utilize resources 
• Plans studies, including timeline to follow and be met by incumbent 
• Coordinates execution of study according to plan 
• Compiles, analyzes, and interprets data leading to reports with conclusions and recommendations to appropriate personnel 
• Understands and follows GMP/GLP regulations.
• May supervise non-exempt personnel to achieve above goals. 
• May work with senior scientific or management staff on major studies assuming scientific responsibility for a portion or portions of the study. 
• Keeps abreast of technological advances specific to the laboratory and adopts and develops new techniques or scientific methods based on findings.
• Maintains Standard Operating Procedures dealing with their work area and recommends new methods and procedures for their area and the laboratory. 
• Provides recommendations based on the data obtained from studies. 
• Maintains a safe and clean working area, and directs others in same. 
• Trains and/or mentors new personnel. 
• Ability to communicate with-in department, with vendors, contractor sites and/or external customers for administrative and technical information.
• Ability to prepare reports of experiments or studies that are grammatically and technically ready for regulatory audit.
• Ability to construct and format reports for the intended audience (i.e. FDA, Production, Laboratory, Customers, or Sales) 
• Ability to present data and make recommendations based on that data to peers and senior scientific staff.
   
  

Position Requirements

• BS in Chemistry and approximately 5 to 7 years laboratory experience.  Minimum of 5 years is required.
• Previous pharmaceutical industry experience.
• Previous Method Development is a must and R&D and QC is preferred.
• Auditing experience and knowledge of GLP, GMP, FDA, and USP is preferred.
• Candidate must be strong using HPLC (Empower)