Associate Director, Drug Substance Manufacturing – Upstream Process

Vera Therapeutics, Inc.; United States; Remote; USD 175,000 - 210,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Vera Therapeutics, Inc. is seeking an Associate Director, Drug Substance Manufacturing – Upstream Process, remote in the United States.

This leadership role oversees biologics upstream manufacturing, technology transfer, and lifecycle management for commercially approved products, partnering with global CMOs and cross‑functional teams. The candidate will author and review CMC regulatory submissions, drive process improvements, and ensure GMP/ICH compliance across sites, with strong project

Qualifications

• MS in life sciences or engineering or related field with relevant experience in biologics upstream processes.
• Hands-on upstream processing including cell culture, harvest, and cell bank management.
• Experience with technology transfer, process validation, and GMP manufacturing.
• Experience leading CMC programs, CDMO management, and regulatory interactions.

Responsibilities

• Serve as primary technical interface with global CMOs for upstream manufacturing.
• Lead investigations for deviations, root cause analyses, and CAPA.
• Supervise campaign readiness, change management, and process optimization discussions.
• Oversee technology transfer and process qualification across CMO sites.
• Author and review validation protocols, reports, and technical documentation.
• Drive continuous improvement across upstream processes and benchmarking.
• Support CMC/regulatory submissions (NDA, BLA, MAA) and post‑approval changes.

Skills

Leadership

MSAT experience

Cell culture

Process validation

Risk management

Regulatory knowledge

GMP familiarity

Data analysis

MS Project

Education

MS in life sciences or engineering

BS with 8 years experience

Tools

MS Project

Job description

Associate Director, Drug Substance Manufacturing – Upstream Process

Remote

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 TRUTAKNA TM (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 – 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.
• 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Vera Therapeutics, Inc.’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.