The Sr. Manager will be responsible for all aspects of drug substance manufacturing for Ashvattha’s products. They will manage the process and analytical development work at the CMO. Responsibilities will also include management of technology transfer from R&D to CMOs and between CMOs, as appropriate. In addition, they will manage the relationship with drug substance CMOs to ensure timely production of high quality cGMP materials for clinical trials and eventual commercial production. It is expected that they will work closely with the R&D function at Ashvattha and external consultants to assure the processes are robust and meet the business and regulatory needs of Ashvattha and its subsidiaries and partners.  The successful candidate will be expected to work on-site a minimum of 2-3 days per week.

Duties and Responsibilities -- Essential Functions

· Lead external drug substance manufacturing for Ashvattha’s portfolio of drugs

· Scale up drug substance for treatment of Severe COVID-19 to Ph3/EUA batches

· Lead tech transfer of small molecule payloads from Ashvattha R&D to external CDMOs

· Shepherd small molecule payloads to optimum pathway, flow vs. batch

Duties and Responsibilities -- Desired Functions

· ADC bioconjugation (click chemistry) experience

· Dendrimer experience

· Flow chemistry and process analytical technologies (PAT) experience

· Understanding of Environmental, Health, and Safety (EHS) compliant handling of highly potent APIs is desired

Job Specification

· Chemical Engineer B.S. with 5+ years industry experience supporting drug substance CMC manufacturing at a biotechnology or pharmaceutical company

· Strong knowledge of GMP guidelines; experience authoring regulatory submissions on drug substance highly preferred

· Understanding of guidelines required by FDA, EMA and other regulatory bodies