Analytical Development Associate - API

The Role

Key Responsibilities

• Method Development & Analysis:

  Perform method development and routine analysis of Key Starting Materials (KSMs), raw materials, intermediates, and drug substances using various analytical techniques, including KF (Karl Fischer), FT-IR, SOR (Specific Optical Rotation), and general wet analysis.

• Routine Operations:

  Manage and execute day-to-day analytical tasks, including receiving test requests for in-process samples, performing routine analysis, and accurately releasing the results in a timely manner.

• Documentation & Compliance:

  Maintain and update instrument logbooks and laboratory notebooks according to Good Laboratory Practices (GLP). All documentation must be thorough, precise, and compliant with internal and regulatory guidelines.

• Laboratory Management:

  Ensure excellent housekeeping and organization within the laboratory. Diligently follow all safety protocols and procedures to maintain a safe and compliant working environment.

• Data Presentation:

  Effectively communicate and present analytical data and results to senior analysts and cross-functional teams.

• Team Collaboration:

  Work seamlessly with the analytical and R&D teams to support ongoing projects and resolve technical challenges.

Core Competencies and Skills

• Technical Proficiency:

  Strong hands-on experience with analytical instruments such as KF, FT-IR, and polarimeters, along with robust knowledge of wet chemical analysis.

• GLP Awareness:

  A solid understanding of GLP and other regulatory requirements relevant to pharmaceutical analytical development.

• Communication:

  Excellent verbal and written communication skills to present data clearly and interact effectively with colleagues.

• Team Player:

  A positive attitude and the ability to collaborate effectively within a team environment.

• Listening Skills:

  The ability to listen attentively to instructions, feedback, and technical information to ensure accuracy and continuous improvement.

• Problem-Solving:

  Strong analytical and problem-solving abilities to troubleshoot and optimize testing procedures.

Qualifications

• M.Sc. in Organic or Analytical Chemistry from a recognized university.