Technical Expert API Processes

Job Description Summary

1. Strong understanding of organic synthesis, reaction mechanisms, and synthetic route design.
2. Expertise in executing a wide range of organic reactions at different scale with good reproducibility and process understanding.
3. Extensive experience in reaction optimization, impurity profiling, and process improvement for enhanced yield and quality.
4. Proficient in structure elucidation of unknown compounds and impurities using analytical techniques such as NMR, LCMS, IR, and HPLC.
5. Skilled in identifying root causes of process failures, OOS results, low yields, and reaction inconsistencies through scientific investigation.
6. Good understanding of scale-up challenges, process robustness, reaction safety, and manufacturability considerations.
7. Experience in identification, isolation, characterization, and synthesis of process-related impurities for regulatory submissions and control strategies.
8. Excellent hands-on expertise in purification techniques including recrystallization, distillation, column chromatography, and preparative TLC.
9. Expertise in writing detailed investigation reports, technical summaries, and scientific documentation for manufacturing support.
10. Strong problem-solving, troubleshooting, and decision-making abilities with the capability to deliver results within challenging timelines.
11. Knowledge of Large Molecules DS would be an added advantage.

Job Description

Position Purpose:

Strong understanding of organic synthesis, reaction mechanisms, and synthetic route design.
   Expertise in executing a wide range of organic reactions at different scale with good reproducibility and process understanding.
    Extensive experience in reaction optimization, impurity profiling, and process improvement for enhanced yield and quality.
    Proficient in structure elucidation of unknown compounds and impurities using analytical techniques such as NMR, LCMS, IR, and HPLC.
    Skilled in identifying root causes of process failures, OOS results, low yields, and reaction inconsistencies through scientific investigation.
   Good understanding of scale-up challenges, process robustness, reaction safety, and manufacturability considerations. Experience in identification, isolation, characterization, and synthesis of process-related impurities for regulatory submissions and control strategies. Excellent hands-on expertise in purification techniques including recrystallization, distillation, column chromatography, and preparative TLC.  Expertise in writing detailed investigation reports, technical summaries, and scientific documentation for manufacturing support.  Strong problem-solving, troubleshooting, and decision-making abilities with the capability to deliver results within challenging timelines. Knowledge of Large Molecules DS would be an added advantage.

Your Key Responsibilities: 

Your responsibilities include, but not limited to

• Strong understanding of organic synthesis, reaction mechanisms, and synthetic route design.
• Expertise in executing a wide range of organic reactions at different scale with good reproducibility and process understanding.
• Extensive experience in reaction optimization, impurity profiling, and process improvement for enhanced yield and quality.
• Proficient in structure elucidation of unknown compounds and impurities using analytical techniques such as NMR, LCMS, IR, and HPLC.
• Skilled in identifying root causes of process failures, OOS results, low yields, and reaction inconsistencies through scientific investigation.
• Good understanding of scale-up challenges, process robustness, reaction safety, and manufacturability considerations.
• Experience in identification, isolation, characterization, and synthesis of process-related impurities for regulatory submissions and control strategies.
• Excellent hands-on expertise in purification techniques including recrystallization, distillation, column chromatography, and preparative TLC.
• Expertise in writing detailed investigation reports, technical summaries, and scientific documentation for manufacturing support.
• Strong problem-solving, troubleshooting, and decision-making abilities with the capability to deliver results within challenging timelines.
• Knowledge of Large Molecules DS would be an added advantage.

What you’ll bring to the role: 

Essential Requirements: 

• Education: PhD / M.Sc. in Chemistry, Chemical Engineering, or related field
• Experience: 12–15 years in API/process development or manufacturing in the pharmaceutical industry.
• Strong knowledge of Organic chemistry and API synthesis routes, Process Development & Optimization etc.

Skills Desired

Applied Statistics, Applied Statistics, Assembly Language, Back-End Development, Biotechnology, Chemical Engineering, Chemistry, Design Development, Electronic Components, General Hse Knowledge  , Incentive Program, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Leadership, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Npd (New Product Development), Process and Cleaning Validation, Process Control, R&D (Research And Development), Root Cause Analysis (RCA), Software Development, Software Engineering {+ 1 more}