Specialist-R&D, Analytical

Key Duties And Responsibilites

• Analytical Method Development: Develop and optimize analytical methods for the characterization of pharmaceutical raw materials, intermediates, and finished products.
• Method Validation: Conduct method validation studies in accordance with regulatory guidelines and internal procedures.
• Sample Analysis: Perform routine and non-routine analysis of samples using various analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution testing).
• Documentation: Prepare and review technical documents, including method development reports, validation protocols, standard operating procedures (SOPs), and regulatory submission documents.
• Compliance: Ensure all laboratory activities comply with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and relevant regulatory requirements.
• Troubleshooting: Identify and resolve technical issues related to analytical methods and instrumentation.
• Data Interpretation: Analyze and interpret analytical data, ensuring accuracy and reliability of results. Prepare detailed reports and presentations of findings.
• Collaboration: Work closely with cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Engineering and Supply chain to support product development and commercialization.
• Laboratory Maintenance: Maintain laboratory equipment and instrumentation, ensuring they are in good working order. Follow all safety protocols and maintain a clean and organized laboratory environment.
• Continuous Improvement: Stay current with industry trends, scientific advancements, and technological innovations to continuously improve analytical methods and practices.
• Any other duties as assigned by supervisor.
  
  

Prefer Skills And Qualifications

• Master’s or Ph.D. or Bachelor’s Degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.
• Associate Scientist: 2+ years of experience in analytical method development in the pharmaceutical industry or related field. Fresh graduate will be considered.
• Scientist: 2 - 5 years of experience in analytical method development in the pharmaceutical industry or related field.
• Hands-on experience with various analytical techniques such as HPLC, GC, UV-Vis, FTIR, and dissolution testing.
• Proficiency in method development and validation in accordance with ICH guidelines.
• Familiarity with regulatory requirements (e.g., FDA, EMA) and quality systems (e.g., GLP, GMP).
• Experience with advanced analytical techniques (e.g., mass spectrometry, NMR).
• Knowledge of statistical tools and software for data analysis (e.g., Empower, ChemStation, Minitab).
• Previous experience in preparing regulatory submission documents (e.g., IND, NDA, ANDA).
  
  

To Apply

Candidates are encouraged to apply this position via email to [email protected] with the following information in the resume.

• Work experiences and job responsibilities.
• Current and Expected salary
• Reason for leaving.
• Date of availability
• Education background
  
  

We regret that only shortlisted candidates will be contacted.

Key Duties And Responsibilites

• Analytical Method Development: Develop and optimize analytical methods for the characterization of pharmaceutical raw materials, intermediates, and finished products.
• Method Validation: Conduct method validation studies in accordance with regulatory guidelines and internal procedures.
• Sample Analysis: Perform routine and non-routine analysis of samples using various analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution testing).
• Documentation: Prepare and review technical documents, including method development reports, validation protocols, standard operating procedures (SOPs), and regulatory submission documents.
• Compliance: Ensure all laboratory activities comply with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and relevant regulatory requirements.
• Troubleshooting: Identify and resolve technical issues related to analytical methods and instrumentation.
• Data Interpretation: Analyze and interpret analytical data, ensuring accuracy and reliability of results. Prepare detailed reports and presentations of findings.
• Collaboration: Work closely with cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Engineering and Supply chain to support product development and commercialization.
• Laboratory Maintenance: Maintain laboratory equipment and instrumentation, ensuring they are in good working order. Follow all safety protocols and maintain a clean and organized laboratory environment.
• Continuous Improvement: Stay current with industry trends, scientific advancements, and technological innovations to continuously improve analytical methods and practices.
• Any other duties as assigned by supervisor.
  
  

Prefer Skills And Qualifications

• Master’s or Ph.D. or Bachelor’s Degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.
• Associate Scientist: 2+ years of experience in analytical method development in the pharmaceutical industry or related field. Fresh graduate will be considered.
• Scientist: 2 - 5 years of experience in analytical method development in the pharmaceutical industry or related field.
• Hands-on experience with various analytical techniques such as HPLC, GC, UV-Vis, FTIR, and dissolution testing.
• Proficiency in method development and validation in accordance with ICH guidelines.
• Familiarity with regulatory requirements (e.g., FDA, EMA) and quality systems (e.g., GLP, GMP).
• Experience with advanced analytical techniques (e.g., mass spectrometry, NMR).
• Knowledge of statistical tools and software for data analysis (e.g., Empower, ChemStation, Minitab).
• Previous experience in preparing regulatory submission documents (e.g., IND, NDA, ANDA).
  
  

To Apply

Candidates are encouraged to apply this position via email to [email protected] with the following information in the resume.

• Work experiences and job responsibilities.
• Current and Expected salary
• Reason for leaving.
• Date of availability
• Education background
  
  

We regret that only shortlisted candidates will be contacted.