Full-Time
Associate Director
Drug Substance Manufacturing, Downstream Process
Vera Therapeutics
201-500 employees
Develops therapies for immunologic diseases
Compensation Overview
$175k - $210k/yr
Brisbane, CA, USA
In Person
Bachelor's, Master's
 Biology & Biotech (1) |
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- A Master of Science degree in a relevant life sciences or engineering discipline with a minimum of 5 years of pharmaceutical or biotechnology industry experience, or a Bachelor of Science degree with 8 years of experience, in biologics drug substance downstream processes, technology transfer, and current Good Manufacturing Practice manufacturing operations.
- Extensive hands-on experience in downstream unit operations, including chromatography, ultrafiltration/diafiltration, viral clearance, and other protein purification methodologies.
- Working knowledge of technology transfer, process validation, and routine management of Good Manufacturing Practice manufacturing.
- Experience managing United States and international contract development and manufacturing organizations to support commercial manufacturing of biologic drugs.
- Proven leadership and cross-functional management of chemistry, manufacturing, and controls-related programs, with a track record of driving and managing programs, overcoming challenges, and managing risks.
- Critical thinking and problem-solving skills to drive risk-based decision-making.
- Strong organizational and project management skills, including proficient use of Microsoft Project and other tools.
- Excellent communication and interpersonal skills when working across the organization.
- Serve as the primary technical interface with global contract manufacturing organizations supporting drug substance manufacturing downstream activities.
- Lead investigations for technical deviations, root cause analyses, and corrective and preventive action implementation.
- Supervise campaign readiness, change management, and process development discussions.
- Lead internal technical meetings and contribute to managing timelines, supply impact, risks, and budget.
- Oversee technology transfer, process performance qualification readiness, and validations across contract manufacturing organization sites.
- Author and review validation protocols, reports, and technical documentation.
- Drive continuous improvement initiatives across downstream processes.
- Drive standardization and knowledge-sharing practices across sites and the global network.
- Perform statistical analysis on campaign data to create and analyze process trends and control charts.
- Develop near-term and long-term lifecycle management and process improvement strategies, and facilitate execution using digital tools such as big data modelling tools for commercial products across manufacturing sites.
- Establish and maintain robust process monitoring and Continuous Process Verification protocols and procedures.
- Author and review chemistry, manufacturing, and controls sections for global regulatory submissions, including New Drug Applications, Biologics License Applications, Marketing Authorisation Applications, New Drug submissions, and International Product Marketing and Development submissions.
- Support filing in new markets and conduct impact assessments for post-approval changes.
- Support responses to health authority questions related to manufacturing processes and controls.
- Ensure manufacturing and validation strategies align with Good Manufacturing Practice, International Council for Harmonisation, and global regulatory expectations.
Vera Therapeutics is a clinical-stage biotechnology company developing therapies for immunological diseases, with a focus on IgA nephropathy and BK virus management. Its lead asset, MAU868, is a neutralizing antibody that targets BK virus and is developed under an exclusive worldwide license from Pfizer. The company differentiates itself through the Pfizer license and a strategy that emphasizes licensing and commercialization to bring therapies to immunocompromised patients, especially those undergoing organ or stem cell transplants. The goal is to improve outcomes for patients with immunologic and rare diseases by translating research into accessible treatments and building a high-performance organization.
Company Size
201-500
Company Stage
IPO
Headquarters
Brisbane, California
Founded
2016
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Simplify's Take
What believers are saying
- FDA approval on July 7, 2026 opens immediate U.S. revenue and launch execution.
- ORIGIN 3 eGFR results arrive in Q3 2026, enabling full-approval filing.
- Vera held $596.8 million cash and a $500 million Oxford facility in March 2026.
What critics are saying
- Novartis won full IgAN approval July 17, 2026, stealing physician attention and formulary slots.
- Vertex's povetacicept faces a November 30, 2026 PDUFA, compressing Vera's first-mover advantage.
- ORIGIN 3 confirmatory data controls TRUTAKNA's future; failure triggers withdrawal and crushes the franchise.
What makes Vera Therapeutics unique
- TRUTAKNA became the first FDA-approved dual BAFF/APRIL IgAN therapy on July 7, 2026.
- Patients self-inject weekly at home, reducing infusion-center dependence and boosting convenience.
- Vera controls atacicept, VT-109, and MAU868 worldwide, with Stanford-backed BAFF/APRIL science.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Health Savings Account/Flexible Spending Account
Unlimited Paid Time Off
Flexible Work Hours
Remote Work Options
Paid Vacation
Paid Sick Leave
Paid Holidays
Sabbatical Leave
Hybrid Work Options
Stock Options
Company Equity
401(k) Retirement Plan
401(k) Company Match
Performance Bonus
Profit Sharing
Conference Attendance Budget
Training Programs
Tuition Reimbursement
Professional Certification Support
Mentorship Program
Wellness Program
Mental Health Support
Gym Membership
Commuter Benefits
Phone/Internet Stipend
Home Office Stipend
Legal Services
Employee Discounts
Company Social Events
Adoption Assistance
Childcare Support
Elder Care Support
Parental Leave
Family Planning Benefits
Fertility Treatment Support
Growth & Insights and Company News
6 month growth
↑ 6%1 year growth
↑ 2%2 year growth
↑ 5%Vera Therapeutics has appointed Nancy Boman as Chief Regulatory Officer, replacing William Turner, who is retiring after helping secure accelerated approval for the company's first therapy, TRUTAKNA (atacicept-vymj), for IgA nephropathy. Turner will transition to a Strategic Advisor role in the third quarter. Boman brings over 25 years of regulatory affairs experience. She previously served as Chief Regulatory Officer at Kyverna Therapeutics, Adicet Bio, Encoded Therapeutics, and Novartis Gene Therapies. She also held leadership positions at Amgen, Genentech, and Alder. The Brisbane, California-based commercial-stage biotechnology company plans to pursue new indications for TRUTAKNA in other autoimmune kidney diseases whilst developing approval pathways for other molecules in its pipeline.
The US Food and Drug Administration has granted accelerated approval to Vera Therapeutics' TRUTAKNA for treating adult patients with primary IgA nephropathy at risk for disease progression. TRUTAKNA is the first therapy that binds both B-cell activating factor and A proliferation-inducing ligand, targeting immunological drivers of the disease. In the interim analysis of the ongoing ORIGIN 3 trial, participants achieved a 46% reduction from baseline in proteinuria, with a 42% reduction compared to placebo at 36 weeks. The therapy is administered as a 150 mg subcutaneous injection once weekly via an autoinjector at home. The accelerated approval is based on proteinuria reduction. Continued approval depends on verification of clinical benefit in the ongoing trial, with results expected in Q3 2026.
Vera Therapeutics, a biotechnology company developing treatments for immunological diseases, reported a first-quarter net loss of $121 million, or $1.69 per share, compared to a $51.7 million loss in the same period last year. The FDA granted priority review to Vera's biologics licence application for atacicept, an investigational treatment for IgA Nephropathy in adults, with a target decision date of 7 July 2026. The company is preparing for a mid-2026 US commercial launch pending regulatory approval. Vera reported $596.8 million in cash, cash equivalents and marketable securities as of 31 March 2026, which it believes will fund operations beyond potential approval and commercial launch. The company anticipates initial results from its PIONEER Phase 2 trial in the second quarter of 2026.
Vera Therapeutics to participate in the Bank of America Securities 2026 Health Care Conference. GlobeNewswire | Vera Therapeutics Today at 4:30am PDT BRISBANE, Calif., May 04, 2026 (GLOBE NEWSWIRE) - Vera Therapeutics, Inc. (Nasdaq: VERA), a biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that the Company's management team will present at the Bank of America Securities 2026 Health Care Conference, which is taking place in Las Vegas, NV from May 12-14, 2026. The management team will also participate in one-on-one investor meetings. Presentation Details: Date: Wednesday, May 13, 2026 Time: 4:20 PM PDT Webcast: https://bofa.veracast.com/webcasts/bofa/healthcare2026/24Ty86.cfm A replay of the event will be available for 90 days and can be accessed by visiting the "Investor Calendar" section of the Vera Therapeutics website. About Vera Therapeutics Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics' mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com. Forward-looking Statements Statements contained in this press release regarding matters, events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera Therapeutics' plans, commitments, aspirations and goals related to its product candidates. Words such as "anticipate," "believe," "expect," "may," "plan," "potential," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera Therapeutics' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera Therapeutics' business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera Therapeutics' filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. This is a paid placement. For further inquiries, please contact GlobeNewswire directly.
Vera Therapeutics has granted inducement awards to Jane Wright-Mitchell, its new Chief Legal Officer, consisting of non-qualified stock options to purchase 56,850 shares and restricted stock units underlying 42,403 shares of Class A common stock. The Compensation Committee approved the awards on 23 March 2026 under the company's 2024 Inducement Plan. The stock options have an exercise price of $40.73 per share and will vest over four years, with 25% vesting after the first anniversary and the remainder vesting monthly over 36 months. The RSU award will vest 25% annually over four years starting 20 May 2026. Vera Therapeutics is a late clinical-stage biotechnology company developing treatments for immunological diseases, with atacicept as its lead product candidate targeting autoimmune diseases including IgAN and lupus nephritis.