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 Phghr@pharmagend.com 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.