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:

1. Manage analytical development projects from conception to completion, ensuring alignment with project timelines, budgets, and objectives.
2. 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.
3. Design and execute stability studies to assess the stability of drug substances and drug products under various conditions, in accordance with regulatory guidelines.
4. Collaborate cross-functionally with formulation scientists, process chemists, and regulatory affairs professionals to support drug development programs and regulatory submissions.
5. Troubleshoot and resolve technical challenges related to analytical methods, instrumentation, and data interpretation.
6. Maintain accurate and detailed records of experimental procedures, results, and conclusions in compliance with company policies and regulatory requirements.
7. 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.
8. Participate in internal and external audits, as needed, to ensure compliance with regulatory requirements and quality standards.
9. Contribute to the preparation of regulatory documents, including INDs, NDAs, and IMPD submissions, by providing analytical data, summaries, and interpretations.
10. Mentor and train junior staff members in analytical techniques, laboratory procedures, and best practices.

Qualifications:

1. Bachelor's, Master's, or Ph.D. degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
2. 4+ years of experience in pharmaceutical analytical development, preferably in a research and development or CMC-focused role.
3. Demonstrated expertise in developing and validating analytical methods for the analysis of small molecules, peptides, or biologics.
4. Proficiency in analytical techniques such as HPLC, GC, LC-MS, FTIR, UV-Vis spectroscopy, and dissolution testing.
5. Strong understanding of regulatory guidelines (e.g., FDA, EMA, ICH) governing pharmaceutical development and quality control.
6. Excellent problem-solving skills with the ability to troubleshoot analytical challenges and propose innovative solutions.
7. Effective communication and collaboration skills, with the ability to work cross-functionally in a fast-paced, dynamic environment.
8. Detail-oriented with a commitment to producing high-quality, reliable analytical data.
9. Experience with statistical analysis software (e.g., JMP, Minitab) is desirable.
10. Prior experience in mentoring and training junior staff members is a plus.