Associate Director/Director of Analytical Development
Responsible for leading the analytical development activities in a virtual CMC environment.
Key factors for role
- Manages external analytical vendors
- Reviews and finalizes analytical raw material, in-process, release methods, protocols, reports and stability results
- Maintains high standards of quality and regulatory compliance
- Identifies areas of improvement of analytical methods and trouble-shoots analytical problems
- Provides statistical analysis of analytical results to support stability assessments
- Prepares and reviews analytical chemistry for the CMC section of drug substance and drug product regulatory submission (INDs, IMPD, Briefing Documents)
- Interacts with US and/or EU Regulatory as it relates to questions regarding analytical development
Knowledge and Skill Requirements
- PhD in a science related to Pharmaceutical Analysis with 10+ years working in analytical development in a pharmaceutical or biotechnology environment, experience in a virtual environment a plus
- Excellent technical knowledge of current drug substance and drug product analytical techniques (HPLC, GC, MS, IR, IC, NMR, XRPD)
- Method development and validation expertise
- Ability to perform statistical analysis of analytical results to support stability assessments
- Knowledge of the most current Regulatory/QA/ICH guidance to ensure that all laboratory work and documentation is completed to the highest quality compliance standards
- Experience auditing external analytical suppliers working in GMP/GLP environments
- Familiar with Out of Specification (OOS) investigational procedures and able to conduct them promptly and thoroughly
- Excellent written and oral skills
- Strong organizational skill to manage a large volume of analytical documentation in a controlled manner
- Experienced in representing analytical development on multifunctional teams
- Management experience overseeing analytical group members working in a team-oriented CMC environment.
- Experience with electronic submissions a plus.
For more information, please contact Careers@EntasisTx.com