Job Title: Chemistry, Manager
Location: St. Louis, MO
Duration: permanent (Full Time)
Job Role:
• This position will supervise a group of chromatography analysts for compendial, material and drug product testing in a cGMP environment and will be required to develop resource plans that meet revenue goals with regards to safety, quality, output and cost.
• The supervisor will conduct investigations for OOS results, errors and deviations.
• The position requires regular communication with clients in a timely and professional manner.
• The supervisor is responsible for ensuring proper staff training and that deliverables are met or expectations are proactively managed towards alternative solutions.
Key Job Responsibilities:
• Optimizes efficiency of the working environment of the group.
• Ensures training of the group is complete.
• Ensures adherence to personnel and equipment SOPs and other regulatory requirements.
• Pays specific attention to equipment operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run project and repeat of work.
• Makes project/work assignments with communication of the expected timeline.
• Monitors the progress against the timeline.
• Provides troubleshooting support as needed.
• Monitors the quality of the group.
• Effectively communicates with clients and internal groups.
• Evaluates personnel in a timely manner.
• Conducts investigations individually and in conjunction with clients.
• Must be proficient in technical writing.
Qualifications:
• An MS/BS in Chemistry or related field with 5+ years of experience in chromatography (HPLC and GC) techniques.
• Must have a minimum of 3 years in pharmaceutical cGMP laboratory.
• This position requires strong verbal and written communication skills, a thorough understanding of client management, and ability to train staff.
• Previous supervisory experience strongly preferred.
Experience:
• Compendial Testing and wet chemistry techniques
• Experience with OOS investigations to include deviations, LIRs, Kappas
• Method development/validation (Chromatography method development and validation, method verification and method transfer is desired)
• Protocol and report writing, and technical trouble-shooting skills in a GMP environment.
• Routine and non-routine testing using LC/MS and/or GC/MS
• Experience in structural characterization of small molecules by LC-MS/MS and mass spectrometric analysis of biologics including analysis of intact proteins, peptide mapping, and characterization of glycans