Who We Are

Ashvattha Therapeutics Inc. is a clinical stage biopharmaceutical company developing products for the unmet medical needs utilizing a novel dendrimer technology exclusively licensed from Johns Hopkins University. We are currently looking for an individual who is  interested in using their skills and knowledge to build a world class manufacturing organization.

The Role

The individual will play a key leadership role in driving and executing manufacturing activities required to support our portfolio of drug candidates from development through to commercialization.  The VP/SVP will be responsible for building and leading a team of professionals responsible for manufacturing operations including overseeing all aspects of DS and DP process scale up, technology transfer and cGMP manufacturing at contract manufacturing sites and future manufacturing network expansions. They will facilitate a solution-focused, scientifically robust culture that meets quality, regulatory compliance and financial requirements.  To ensure collaboration among our staff, employees are required to work on site a minimum of 2-3 days per week.

Key Deliverables

• Build a manufacturing team to support Phase 3 and commercial,
• Ensure successful 10x scale up of lead product, OP-101, and core HD platform by end 2022,
• Establish long range plan to significantly reduce cost of goods on first two products by 2024,
• Develop manufacturing plan to address potential accelerated approval/EUA for OP-101 in Q4 2022

Core Skills & Experience Required

• Extensive experience in GMP manufacturing
• Understanding of development stage appropriate regulatory requirements for GMP production, testing and release
• Knowledge of ICH CMC guidances, Experience in FDA interactions including End of Phase 2, Pre-NDA/BLA, and Pre-Approval Inspections
• Previous experience taking a drug through successful global market launch

UNSOLICITED RESUMES FROM SEARCH FIRMS WILL NOT BE ACCEPTED