Associate Director / Manager, Analytical Development
Eloxx Pharmaceuticals, Inc. (http://www.eloxxpharma.com/ ) is a clinical-stage biopharmaceutical company developing novel small molecule medicines to treat many rare and ultra-rare genetic diseases caused by nonsense mutations. Nonsense mutations are a class of genetic defects that result in premature termination of protein synthesis. These nonsense mutations have been identified in over 2,000 rare and ultra-rare diseases. As a consequence, patients with a genetic disease caused by nonsense mutations have absent or truncated nonfunctional proteins, accounting for some of the most severe phenotypes in these genetic diseases. Eloxx’s lead product candidate, ELX-02, is an investigational, novel translational read-through inducing drug designed to restore synthesis of full-length functional proteins. ELX-02 is an investigational agent undergoing clinical trials and has not been approved by any global regulatory body. Eloxx was founded in 2013 and is headquartered in Waltham, MA. with R&D operations in Rehovot, Israel.
This is an opportunity to join a growing and energetic team, build a high performing company, gain personal development and transform patient lives.
Oversees the development, implementation and maintenance of quality assurance systems and activities. Oversees generation and review of documents used in Good Manufacturing Practices. Also monitors audits of production and Quality Control areas. May audit raw material vendors and prepares manufacturing documentation for updated filing. Coordinates interdepartmental activities. May lead investigations and resolve potential product quality issues to improve efficiency.
Essential Job Responsibilities
- Manage the scientific, regulatory, quality and budgetary aspects of all analytical chemistry contractors.
- Manage all manufacturing, testing, quality and compliance aspects of clinical trial materials for clinical trials. This includes “man in the plant” activities and review/release of batch records for CTM.
- Coordinate all CMC aspects of the development program.
- Oversee the stability data for all company development programs.
- Lead the vendor quality assessment and compliance program for CMC related contractors, which include, process of development labs, API manufacturing, drug product manufacturing, release testing labs, analytical development labs and distribution facilities.
- Regulatory responsibilities which include, coordination of the preparation of the CMC sections for IND’s and their updates and the preparation and updating of the stability and analytical sections of NDA’s.
- Oversee the inventory of API and CTM to ensure all clinical trials have sufficient product to support them.
- Management of materials inventory to ensure clinical trials run without holds.
- BS in science with an advanced degree in analytical chemistry preferred
- 8-12 years of experience in the pharmaceutical/and or biotechnology industry
- Experience with contract labs or managing outsourcing in a drug development industry, stability studies for pharmaceutical products, HPLC method development and validation, project management, API manufacturing, technical/regulatory writing and audits.
- Ability to travel 30%
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