About the role
Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNATM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand ( APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit www.veratx.com . At Vera, our values are the cornerstone of our culture and guide
how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney. Position Summary: The Associate Director, Drug Substance Manufacturing – Downstream Process will report to the VP, Commercial Manufacturing Operations and will be responsible all aspects of Drug Substance (DS) manufacturing with expertise in downstream processing. The individual will serve as a subject matter expert (SME) in downstream processes for outsourced drug-substance manufacturing, technology transfer, life cycle management, and global regulatory submissions of complex Biologics, monoclonal antibodies, and other recombinant therapeutics. Working with the CMC team and other key functions such as project management, QA and Regulatory, the ideal candidate must be an outstanding leader with a proven track record of overseeing all drug-substance downstream manufacturing activities at the CMO site, including process scale-up, technology transfers, validations, PPQ campaign support, continuous process improvements, and post-approval lifecycle management of commercially approved products. In addition,
the role requires authoring, reviewing, and editing of CMC related regulatory submissions (e.g., BLA, MAA) and associated quality documents. The candidate must have exceptional organizational and communication skills, be capable of communicating strategic plans to upper management, summarize data, and effectively manage interactions with stakeholders across functions.