Senior Manager - Upstream (Microbial Fermentation)
- Hyderabad, IN
2022-09-23 11:41:16 UTC
PopVax is an Indian biotechnology company based in Hyderabad building a novel thermostable, low-cost, and safe second-generation mRNA platform for rationally-designed broadly-protective multi-epitope vaccines. We’re starting with a 4-8 °C refrigerator-stable booster vaccine candidate that is intended to protect against the entire sarbecovirus sub-family, including current and future strains of SARS-CoV-2 (the virus which causes COVID-19), and some other beta-coronaviruses such as MERS-CoV.
We’re looking for an exceptional upstream manufacturing manager with at least 10 years of experience in cGMP vaccine or biologics production focusing on microbial fermentation, from cell banking all the way to purification, ideally with particular experience in producing pDNA using E. coli, to run pDNA template production for our mRNA IVT process.
Strong hands-on experience in qualifying and operating microbial fermenters of different scales in a cGMP environment, including media simulation
Coordination with cross functional teams for ensuring the qualification status of their relevant area and equipment
Exposure to and participation in regulatory audits, ideally for all of CDSCO/DCGI, WHO, and US FDA
Ability to conceptualize, write, follow, and train others on SOPs for cGMP processes and relevant equipment
Experience in making production schedules for the smooth functioning of production activities
Experience maintaining batch records
Experience dealing with change controls, devations, incident investigations, and other elements of quality management systems
Demonstrated experience recruiting, training, and managing a team succesfully in a fast-paced cGMP enviroment
Background knowledge of environmental monitoring in cGMP facilities as well as qualification parameters of key clean utilities
Exceptional oral and written communication skills, with the ability to conceptualize and produce comprehensive reports on the state of the process, a piece of equipment, or a specific batch rapidly and independently
We offer very competitive compensation, comprehensive health insurance covering immediate family (including pre-existing conditions), and, most importantly, a collaborative work environment focused on solving the cutting-edge multidisciplinary challenges of our novel mRNA platform.