Job Title : Head of Analytical R&D
Job Summary : We are seeking a dynamic and experienced Head of Analytical R&D to lead our Method Development and Validation team in support of Drug Product Development.
This role is critical in overseeing analytical efforts from preclinical through IND / NDA, 505(b)(2) and ANDA submissions, primarily focusing on small molecule drug development, with an emphasis on strong leadership and project management skills.
Key Responsibilities :
- Lead and manage the Analytical R&D team, ensuring successful method development and validation.
- Provide analytical support for new drug development, from preclinical through IND / NDA submissions.
- Oversee analytical aspects of drug product development, ensuring compliance with regulatory standards.
- Collaborate with cross-functional teams to support overall drug development projects.
- Manage timelines, resources, and budgets for analytical projects.
- Maintain up-to-date knowledge of regulatory requirements and industry trends.
- Support biologics development as needed, although the primary focus is on small molecules.
Qualifications :
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- Extensive experience in analytical R&D, with a strong background in method development and validation.
- Proven track record of providing analytical support for IND / NDA submissions.
- Experience in new drug development from preclinical to regulatory submission stages.
- Strong leadership and project management skills.
- Excellent communication and interpersonal abilities.
- Proficiency in instrumental techniques such as HPLC, GC, MS, NMR, and FTIR.
30+ days ago