Hiring For Senior Research Associate - Analytical

API analytical job in the pharmaceutical industry involves developing and validating analytical methods for active pharmaceutical ingredients (API), analyzing impurities, Method Validation transfers, and ensuring regulatory compliance.

Key responsibilities include using techniques like HPLC, GC, and LC-MS, documenting results, troubleshooting issues, and collaborating with R&D, quality, and regulatory teams.

Key responsibilities:

• Method development and validation:

  Develop, optimize, and validate analytical test methods for raw materials, intermediates, and APIs, ensuring they comply with regulatory guidelines.

• Analytical testing:

  Perform testing and analysis using techniques such as HPLC, GC,MS and others to ensure the quality and purity of APIs.

• Impurity analysis:

  Identify, separate, and quantify impurities and degradation products in APIs.

• Troubleshooting:

  Solve complex analytical challenges and troubleshoot issues with methods and instrumentation.

• Documentation:

  Prepare and review analytical method protocols, validation reports, and other technical documents.

• Regulatory compliance:

  Ensure all analytical work adheres to regulatory requirements, such as those from the FDA and EMA, and participate in audits.

• Collaboration:

  Work with cross-functional teams, including R&D, Quality Assurance (QA), and Regulatory Affairs, to support product development and manufacturing.

• Instrumentation and maintenance:

  Maintain laboratory instruments and ensure the lab environment is properly managed.

• Technology transfer:

  Assist with technology transfer activities and scale-up of processes.

• Data analysis:

  Analyze and interpret experimental data, and present findings in a clear and concise manner.

Required skills and qualifications:

• Technical skills:

  Expertise in analytical techniques like HPLC, GC, LC-MS,

• Pharmaceutical knowledge:

  Understanding of GMP, API process development, quality control, and quality assurance principles.

• Regulatory awareness:

  Familiarity with regulatory guidelines from agencies like the FDA, EMA, and ICH.

• Problem-solving:

  Strong analytical and problem-solving abilities to handle complex challenges.

• Soft skills:

  Excellent communication, teamwork, and project management skills.

Interested candidates can share their resume at shikha.mishra@walterbushnell.com