Associate Director, Drug Substance Manufacturing – Upstream Process

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. Technology Transfer & Validation Oversee technology transfer and process qualification across CMO sites. Author and review validation protocols, reports, and technical documentation. Drive continuous improvement initiatives across upstream processes. Drive industry benchmarking and knowledge-sharing across teams. Lifecycle Management & CPV Perform statistical analysis on campaign data to create and analyze process trends and control charts. Develop near-term and long-term lifecycle management / process improvement strategies. Facilitate execution utilizing digital tools (e.g., big data modelling tools), as applicable, for commercial products across manufacturing sites. Establish and maintain robust process monitoring and Continuous Process Verification (CPV) protocols /procedures. CMC & Regulatory Support Author and review CMC sections for global regulatory submissions (NDA, BLA, MAA). Support filing in new markets and conduct impact assessment to post‑approval changes. Support responses to health authority questions related to manufacturing processes and controls. Ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations.

Qualifications: 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 upstream processes, technology transfer, and cGMP manufacturing operations. 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. Vera Therapeutics Inc. is an equal-opportunity employer. Vera Therapeutics is committed to fair and equitable

compensation practices and we strive to provide employees with total

compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography,

qualifications, skills, and experience. For this role, the anticipated base pay range is $175,000 — $210,000 USD At Vera, base pay is only one part of your total

compensation package. The successful candidate will be eligible for an annual performance incentive

bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various

benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays. Notice to Recruiters/Staffing Agencies Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees. Fraud Alert To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/ . Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources. CA Privacy Notice Applicants residing in California should review our California Privacy Notice for Employees, Job Applicants, and Contractors, which describes the categories of personal information we collect, how we use it, and your privacy rights under the California Consumer Privacy Act, as amended by the California Privacy Rights Act: https://veratx.com/ca-privacy/ .

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