Associate Director, Drug Substance Manufacturing – Upstream Process
Lead upstream biologics manufacturing for a biotech company, overseeing CMO partnerships, process scale-up, tech transfers, and regulatory submissions for monoclonal antibodies and other recombinant therapeutics.
- Compensation
- $175K–$210K / yr
- Location
- Remote
- Work setup
- Remote
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 5+ years
- Category
- Not specified
- Posted
Skills
Must have
- MS in relevant life sciences or engineering discipline with a minimum of 5 years of Pharmaceutical/Biotechnology industry experience (or BS with 8 years of experience) in biologics drug substance upst
- Experience in process development and/or manufacturing sciences and technology (MSAT) is preferred.
- Extensive hands-on experience in upstream processing including cell bank management, cell culture (expansion and production), and harvest.
- Working knowledge of technology transfer, process validation, and routine management of GMP manufacturing.
- Experience in managing US/international CDMOs to help support commercial manufacturing of biologic drugs.
- Proven leadership and cross-functional management of CMC-related programs. Track record of successfully driving and managing programs, overcoming challenges, and managing risks.
- Critical thinking and problem-solving skills with ability to drive risk-based decision making.
- Strong organizational and project management skills, including proficient use of MS Project and other tools.
- Excellent communication and interpersonal skills in working across the organization.
Full description
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 .
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 – Upstream Process will report to the VP, Commercial Manufacturing Operations and will be responsible all aspects of Drug Substance (DS) biologics manufacturing with expertise in upstream processing. The individual will serve as a subject matter expert (SME) in upstream 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 upstream 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.
Responsibilities: Technical Oversight & Manufacturing Support
- Serve as primary technical interface with global CMOs supporting Drug Substance manufacturing upstream activities.
- Lead investigations for technical deviations, root cause analyses, and CAPA implementation.
- Supervise campaign readiness, change management, and process optimization discussions.
- Lead internal technical meetings and contribute to managing timelines, supply impact, risks, and budget.