Analytical Scientist III
Atlanta, GA 30301
Analytical Scientist III
The Scientist III position is a highly experienced chemist within the Analytical Development laboratory with a strong working knowledge of both analytical and organic chemistry. The purpose of this position is to support early stage product development through commercialization. The Scientist III will be expected to support/troubleshoot the formulation and manufacturing processes, identify potential negative interactions, degradation pathways, subsequent impurities, and degradants. The Scientist III would also be expected to perform duties including, but not limited to, the qualification of analytical instrumentation, method development and validation, and method transfer activities.
- Utilize knowledge of mechanistic organic chemistry to identify issues in drug product formulations
- Predict impurity profiles and degradation pathways for active pharmaceutical ingredients and drug product by using the structures of active pharmaceutical ingredients and excipients
- Working in line with the scope of the project, participate in or lead the design/evaluation and execution of routine and more complex testing or studies.
- Provide analytical leadership of one or more client projects and represent the function on client project team(s). Present interpreted results and updates to internally and to individual clients in a timely and professional manner.
- Performs method development/validation and method transfer.
- Develops analytical methods for dissolution and chromatographic analysis.
- Authors/reviews validation and method transfer protocols.
- Acts as subject matter expert for analytical technology transfer.
- Review all relevant data (stability, specifications) in order to identify and report trends or OOS results
- Participate in or lead problem solving (scientific, equipment, process). Assist in trouble shooting and investigations as required
- Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation.
- Authors/reviews analytical protocols, SOPs, reports and related documentation.
- Authors/reviews laboratory investigations. Conducts investigations, determines root cause and documents results, as needed, in compliance with SOPs.
- Assists laboratory management with acquisition, upgrade and qualification of instruments.
- Bachelor’s degree in Analytical/Organic Chemistry or related scientific discipline is required.
- Master’s Degree in Analytical or Organic Chemistry or related scientific discipline is highly preferred.
- Minimum of Ten (10) years of work experience in pharmaceutical or related laboratory work is required.
- Hands on experience with pharmaceutical analytical method development is required.
- Method development and validation experience for small molecule compounds is required.
- Experience writing method validation protocols and reports, SOP's, technology transfer and other technical summary reports is required.
- Demonstrates advanced technical knowledge of analytical methods. Working knowledge of GLP/cGMP regulations and safety procedures.
- Maintains knowledge of pertinent literature, regulatory guidelines, laboratory techniques and instrumentation relevant to the discipline, area or section.
- Knowledge of analytical development, pharmaceutical development and ability to support and coordinate projects in various stages of the development process.
- Good technical writing and communications skills.
- Good interpersonal skills and ability to work effectively in a team environment and client companies.
- The candidates must demonstrate a good understanding of basic chemistry and spectroscopic technologies (e.g. Ultraviolet (UV), Infrared (IR), Nuclear Magnetic Resonance (NMR), Mass Spectrometry (MS))
- The candidates must demonstrate a good understanding of organic chemistry with respect to pharmaceutical chemical degradation, including identification and mitigation of degradation pathways.
- Candidates should demonstrate a good understanding of chromatographic techniques and basic trouble shooting skills for typical High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) related problems.
- High level of pharmaceutical and technical knowledge and awareness of the drug development process.
- Good understanding of out of specifications Out of Specification (OOS) investigation process
- Good understanding of Good Manufacturing Practices requirements and awareness of relevant International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) guidance documents
- Experience with electronic document management systems (Veeva) and chromatography and data management software (LIMS, Empower/Chemstation).
- Ability to support multiple projects simultaneously and serve as a senior technical contributor and/or independent project team member. May act as a project team lead.