Chemist, Analytical R&D RD6-BPO-AR&D B

Job Summary

The Chemist, Analytical R&D RD6 carries out work related to analytical method development and pre-validation, research & development sample testing, cleaning validation studies and standard certification.

Job Responsibilities

• Carries out work related to analytical method development and pre-validation, R&D Sample testing, cleaning validation studies and standard certification. Ensures work complies with cGMP and regulatory requirements. Develops proper techniques and operational expertise with key laboratory instrumentation including, HPLC/UPLC, GC, KF, UV, IR, Auto titrator, LC-MS, etc.
• Reports all testing results and deviations encountered during testing and recommends improvements to analytical procedures/protocols. Utilizes advanced analytical knowledge, Design of Experiments (DoE) and carries out investigation activities. Troubleshoots and resolves moderate development issues, seeking input from higher-level team members, as required.
• Properly documents analytical data and information. Self-reviews analytical data for accuracy and completeness. Assists in documentation writing and reviewing and assists Analytical R&D lab staff to meet overall project deadlines.
• Carries out Stress Studies, Transportation studies, Stability studies on raw materials and finished products.
• Promptly identifies and discusses problems related to instruments and methods of analysis with the Chemist, Sr/Team Leader.
• Develops critical analytical skills needed for successful method development and method validation activities. Acquires a firm understanding of cGMP fundamentals.
• Laboratory Responsibilities
• Possesses strong method development skills and advanced troubleshooting skills and applies these to the analytical requirements for each R&D project for raw materials, process intermediates and drug substances.
• Maintains an organized and safe laboratory environment. Identified needs for Laboratory supplies. Ensures the work complies with health and safety standards, SOPs, cGMP, and regulatory requirements.
• Presents the technical data in an accurate and organized manner (verbal and written). Possesses the ability to critically assess results for accuracy and precision; suggests or determines critical parameters causing poor or inconsistent results.
• Completes assignments within allotted period to ensure deadlines are met. Possesses well developed multi-tasking abilities. Possesses/develops the ability to adapt to frequent changes in priorities and schedules.
• Continuously upgrades and adds to analytical skill set to include the ability to work with new instrumentation and the ability to learn and apply new analytical techniques (both instrumental and wet chemical).
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Ph.D. in Chemistry from a recognized academic institution, or
  • M.Sc. in Chemistry with a minimum 4 years of experience in a related field, or
  • B.Sc. in Chemistry with a minimum 7 years of experience in a related field
• Knowledge, Skills and Abilities
  • Extensive knowledge and experience operating instruments such as HPLC/UPLC, GC, IC, UV, IR, KF, Potentiometric Titrator etc. NMR and design of experiment (DoE) experience desirable.
  • Extensive knowledge of and experience with standard wet chemistry techniques routinely used in an analytical lab setting as applied in the pharmaceutical field.
  • Familiarity with Method Development and Method Validation is an asset.
  • Firm knowledge of cGMP, USP, BP, EP, ICH, and TPD guidelines and procedures.
  • The ability to work as a member of a team, willingness to upgrade knowledge on an on-going basis.
  • Good communication skills, both verbal and written.
  • Knowledge of Windows OS, Microsoft Office (Word, Excel, PowerPoint), Empower Chromatographic Data System, LabX, Chromeleon