Location
Bhiwadi | India
Job description
Job Description:
We are seeking a highly motivated and skilled Analytical Development Executive to join our pharmaceutical research and development team. The successful candidate will play a critical role in advancing our drug development projects by leading analytical development efforts, ensuring the quality and integrity of our products, and contributing to regulatory submissions.
Key Responsibilities:
- Manage analytical development projects from conception to completion, ensuring alignment with project timelines, budgets, and objectives.
- Develop and validate analytical methods for the characterization, identification, and quantification of drug substances and drug products using a variety of analytical techniques, including but not limited to HPLC, GC, LC-MS, FTIR, and UV-Vis spectroscopy.
- Design and execute stability studies to assess the stability of drug substances and drug products under various conditions, in accordance with regulatory guidelines.
- Collaborate cross-functionally with formulation scientists, process chemists, and regulatory affairs professionals to support drug development programs and regulatory submissions.
- Troubleshoot and resolve technical challenges related to analytical methods, instrumentation, and data interpretation.
- Maintain accurate and detailed records of experimental procedures, results, and conclusions in compliance with company policies and regulatory requirements.
- Stay current with advancements in analytical techniques, regulatory guidelines, and industry best practices to continuously improve analytical capabilities and ensure compliance with evolving regulatory standards.
- Participate in internal and external audits, as needed, to ensure compliance with regulatory requirements and quality standards.
- Contribute to the preparation of regulatory documents, including INDs, NDAs, and IMPD submissions, by providing analytical data, summaries, and interpretations.
- Mentor and train junior staff members in analytical techniques, laboratory procedures, and best practices.
Qualifications:
- Bachelor's, Master's, or Ph.D. degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- 4+ years of experience in pharmaceutical analytical development, preferably in a research and development or CMC-focused role.
- Demonstrated expertise in developing and validating analytical methods for the analysis of small molecules, peptides, or biologics.
- Proficiency in analytical techniques such as HPLC, GC, LC-MS, FTIR, UV-Vis spectroscopy, and dissolution testing.
- Strong understanding of regulatory guidelines (e.g., FDA, EMA, ICH) governing pharmaceutical development and quality control.
- Excellent problem-solving skills with the ability to troubleshoot analytical challenges and propose innovative solutions.
- Effective communication and collaboration skills, with the ability to work cross-functionally in a fast-paced, dynamic environment.
- Detail-oriented with a commitment to producing high-quality, reliable analytical data.
- Experience with statistical analysis software (e.g., JMP, Minitab) is desirable.
- Prior experience in mentoring and training junior staff members is a plus.
Job tags
Salary
Rs 30000 - Rs 40000 per month