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:
We are seeking a Senior Manager, Reference Standards & Reagents to join an experienced, fast-paced, and collaborative CMC team. This role will report to the Associate Director or Director, Quality Control and will provide strategic and operational leadership for lifecycle management of reference standards and critical reagents supporting biologics development and commercial operations.
The successful candidate will partner cross-functionally with Analytical Sciences, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, and external CDMOs/CTLs to ensure compliant qualification, inventory management, distribution, lifecycle oversight of reference standards and critical reagents used in GMP testing, and the associated tracking and trending. This role will support late-stage development, regulatory submissions, commercial activities and inspection preparedness.
Responsibilities:
- Own and manage the lifecycle of reference standards and critical reagents, including primary, working, interim, in-house, compendial, and assay control/standards from receipt and qualification through issuance, requalification, and retirement.
- Review and assess analytical data associated with reference standard qualification, stability monitoring, trending, and assay performance.
- Author, review, and approve GMP documentation including SOPs, qualification/requalification protocols and reports, CoAs/CoCs, deviations, CAPAs, change controls, and technical reports.
- Establish and maintain strategies for qualification, characterization, bridging, and requalification of reference standards and critical reagents to support analytical testing and product release.
- Ensure uninterrupted supply, inventory control, storage, labeling, distribution, and tracking of qualified reference standards and critical reagents for GMP operations.
- Define and oversee appropriate storage, handling, shipping, and environmental monitoring requirements, including management of temperature excursions and investigations.
- Collaborate with Analytical Development, QC, and external laboratories to support method qualification, validation, comparability assessments, and commercial specification setting activities.
- Maintain accurate and inspection-ready records within electronic systems.
- Support investigations related to deviations, OOS/OOT results, atypical trends, and risk assessments associated with reference standards and critical reagents.
- Partner with Regulatory Affairs to support regulatory filings, responses to health authority questions, and preparation of analytical sections related to reference standards and assay controls.
- Support internal audits, external inspections, and health authority inspections by ensuring inspection readiness of documentation and systems.
- Manage activities at CDMOs and contract testing laboratories related to reference standard qualification, inventory management, and analytical support.
- Drive continuous improvement initiatives to enhance operational efficiency, compliance, scalability, and business continuity for reference standard and reagent management processes.
Qualifications:
- PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 3+ years of experience in biologics analytical development, quality control, or GMP laboratory operations, OR
- MS with 6+ years of relevant industry experience, OR BS with 8+ years of relevant industry experience.
- Strong knowledge of biologics Quality Control and industry best practices for reference standards, critical reagents, analytical controls, and stability programs.
- In-depth understanding and application of cGMP principles, data integrity requirements, and regulatory expectations in the US and internationally.
- Experience managing reference standard qualification and lifecycle activities for biologics in clinical and/or commercial environments.
- Experience supporting analytical methods across multiple technologies including chromatography, bioassays, and spectroscopy techniques.
- Experience authoring and reviewing GMP documentation including protocols, reports, SOPs, deviations, investigations, CAPAs, and regulatory filings.
- Experience working with CDMOs and contract testing laboratories in a GMP environment.
- Strong technical, organizational, and problem-solving skills with the ability to independently drive complex projects and develop innovative solutions.
- Excellent verbal and written communication skills and demonstrated ability to work effectively in a team-oriented environment.
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.
