What are the responsibilities and job description for the Head of Analytical R&D position at Gables Search Group?
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 teams in support of Pharmaceutical 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
Job Summary: We are seeking a dynamic and experienced Head of Analytical R&D to lead our Method Development and Validation teams in support of Pharmaceutical 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.
- Must have a Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- Extensive experience (10 years) 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.
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