Analytical Chemist

5 days ago


Charlotte, North Carolina, United States Blue Signal Search Full time
About the Role

We are seeking an experienced Analytical Chemist to join our dynamic team at Blue Signal Search. As a key member of our manufacturing and industrial team, you will play a crucial role in the development and validation of analytical methods, specification establishment, and pharmaceutical product testing.

Key Responsibilities
  • Collaborate with cross-functional teams to lead project development and ensure timely deliverables.
  • Conduct second reviews of analytical results and provide feedback as necessary.
  • Perform instrument troubleshooting, preventive maintenance, and operational qualification of laboratory equipment.
  • Lead analytical tasks associated with product development and communicate progress to relevant departments.
  • Draft specifications and standard operating procedures (SOPs) and generate protocols and reports.
  • Facilitate training sessions for laboratory analysts during method transfer.
  • Maintain a clean and organized laboratory environment to ensure compliance with regulatory standards.
  • Actively participate in cross-departmental meetings and contribute insights as required.
  • Review laboratory notebooks, provide constructive feedback, and ensure compliance with internal protocols.
  • Design method validation protocols and execute validation experiments for drug substances and dosage forms.
  • Analyze data, draw conclusions, and make recommendations based on experimental findings.
Requirements
  • Bachelor's, Master's or PhD degree in Chemistry or a relevant science discipline.
  • Minimum of 5 years' experience in a regulated manufacturing environment.
  • Experience in dissolution, drug impurity method development, and/or method validation preferred.
  • Knowledge of ICH guidelines for drug product analysis and familiarity with analytical data regulatory submission requirements and quality by design principles preferred.
  • Proficiency in chromatography techniques, including gas chromatography (GC) and high-performance liquid chromatography (HPLC).
  • Strong understanding of cGMPs and GLPs, with familiarity in solid analytical techniques.
  • Demonstrated ability to work independently and within a team environment with excellent written and verbal communication skills.
  • Exceptional creativity, innovation, and decision-making skills.
  • Proficiency in Microsoft Office suite and relevant software applications.
  • Flexibility to work flexible hours when necessary.

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