The Role

The Sr. Manager/Director, Downstream Manufacturing will play a critical and highly visible role within the company by leading the overall strategy and focus for downstream manufacturing on our CMC team. They will provide CMC leadership for the Ashvattha drug portfolio, specifically in the areas of downstream purification, formulation, aseptic process, and fill/finish of DS and DP. They will drive all process development, process characterization, scale up, technology transfer, and clinical cGMP manufacture at external Contract Development/Manufacturing Organization (CDMO) manufacturing sites. This position will interface with the Research team to progress molecules from pre-clinical to clinical stage. 

Key Deliverables

· Scale downstream process for Severe COVID-19 therapy enabling Ph3/EUA batches

· Tailor tangential flow filtration processes to hydroxyl dendrimer-drug conjugates

· Develop ion exchange purification for Ashvattha’s companion diagnostic imaging agents

Skills and Knowledge

B.S degree in a related discipline.  Small molecule or ADC bioconjugation (click chemistry) experience. Demonstrated track record of CDMO management.  Expertise in all filtration (depth, direct flow and UF/DF tangential flow) and resin/membrane chromatographic separation techniques (e.g. affinity, IEX, SEC, HIC).  Understanding of membrane-based filtration including hollow fibers, determining critical flux, shear and TMP measurements. Knowledge of current requirements for cGMP is required.

In order to enhance collaboration, we require our employees to work on site 2-3 days per week.

RESUMES FROM SEARCH FIRMS WILL NOT BE ACCEPTED