Title: Associate Director/Director of Analytical Development
Location: Waltham, MA
Associate Director/Director of Analytical Development
Entasis Therapeutic is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including ETX2514SUL (targeting A. baumannii infections) being initiated for Phase 3 clinical trials, zoliflodacin (targeting Neisseria gonorrhoeae) being initiated for Phase 3 clinical trials, and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections).
Entasis is currently seeking an Associate Director/Director in Analytical Development to join their team. In this newly formed role, you will be responsible for analytical development activities in a virtual CMC environment.
- 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 8+ 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.
What Entasis Has to Offer!
Entasis is located in the beautiful and state of the art, Boston Biohub Incubator in Waltham, MA!
Entasis offers a competitive benefits package including Blue Cross Blue Shield PPO/HMO options, Health Savings Accounts with employer contributions, Dental, Vision, 401K plan plus employer match, wellness program, on-site massage/Zumba, Boston Sports Club discounted membership, on-site leagues including our own volleyball team, two catered lunches weekly and a social every Friday afternoon plus much more!
Please learn more by visiting our corporate website at https://www.entasistx.com/
Follow us on LinkedIn at https://www.linkedin.com/company/entasis-therapeutics/
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