Director of Analytical Research and Development
3 days ago
Job Title: Director of Analytical Research and Development
Job Summary: Gable Search Group is seeking a highly experienced and skilled Director of Analytical Research and Development 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: Ensure successful method development and validation, and provide strategic direction to the team.
- Provide Analytical Support: Offer analytical expertise for new drug development, from preclinical through IND/NDA submissions, and ensure compliance with regulatory standards.
- Oversee Analytical Aspects: Ensure that analytical aspects of drug product development are aligned with company goals and objectives.
- Collaborate with Cross-Functional Teams: Work closely with cross-functional teams to support overall drug development projects.
- Manage Timelines, Resources, and Budgets: Effectively manage timelines, resources, and budgets for analytical projects.
- Maintain Knowledge: Stay up-to-date with regulatory requirements and industry trends.
- Support Biologics Development: Provide analytical support for biologics development as needed, although the primary focus is on small molecules.
Qualifications:
- Education: Must have a Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- Experience: Extensive experience (10+ years) in analytical R&D, with a strong background in method development and validation.
- Track Record: Proven track record of providing analytical support for IND/NDA submissions.
- Experience: Experience in new drug development from preclinical to regulatory submission stages.
- Leadership and Project Management Skills: Strong leadership and project management skills.
- Communication and Interpersonal Abilities: Excellent communication and interpersonal abilities.
- Instrumental Techniques: Proficiency in instrumental techniques such as HPLC, GC, MS, NMR, and FTIR.
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