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Head of Bioanalytical Sciences
2 months ago
Job Overview
Position: Head of Bioanalytical Sciences
Location: Remote
Company Overview:
Vera Therapeutics (Nasdaq: VERA) is a pioneering biotechnology firm dedicated to the development of innovative therapies for severe immunological conditions. Our mission is to enhance treatment options that directly address the underlying causes of immunologic diseases, thereby transforming the standard of care for patients. Our flagship product candidate, atacicept, is a fully humanized fusion protein designed for self-administration at home via a weekly subcutaneous injection. It effectively inhibits both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which are critical in the production of galactose-deficient IgA1 (Gd-IgA1) and related autoantibodies, contributing to the formation of immune complexes involved in the pathogenesis of IgA nephropathy (IgAN). Additionally, we are exploring the potential of atacicept in treating other immunological disorders. Furthermore, we are advancing MAU868, a monoclonal antibody aimed at neutralizing BK Virus infections, which can have severe implications in specific scenarios, such as kidney transplants. For further details, please visit our website.
Our core values are integral to our culture, guiding our hiring practices, collaborative efforts, and our ultimate objective of enhancing medical treatments for patients with immunological diseases.
Role Summary:
We are in search of a Head of Bioanalytical Sciences to become a vital part of our dynamic and collaborative team. This role will report directly to the Executive Director of Analytical Sciences and will be instrumental in overseeing all facets of bioanalytical assay development for our antibody and fusion protein products. Collaborating closely with the Analytical Sciences team and key stakeholders from Clinical Research, Clinical Operations, Biostatistics, Quality Assurance, Regulatory Affairs, and Project Management, as well as with Contract Research Organizations (CROs), this position will establish and validate robust bioanalytical methodologies to support clinical trials and global regulatory submissions.
Key Responsibilities:
- Collaborate with the clinical research team to design and implement bioanalytical studies (e.g., PK, ADA, and other biomarkers) that support clinical trials.
- Engage with CROs to develop, validate, and sustain bioanalytical methodologies that underpin Vera's clinical studies.
- Review validation protocols, testing procedures, raw data, and technical reports to ensure scientific rigor and adherence to GLPs/GDPs.
- Work alongside Clinical Operations, Clinical Data Management, and Biostatistics to guarantee the timely collection of high-quality data for clinical studies.
- Draft memos, protocols, reports, and analytical sections for regulatory submissions.
- Lead the selection of CROs and oversee timelines, budgets, shipments, and inventory management.
- Assist in Quality audits, address deviations, and support troubleshooting activities.
- PhD in Chemistry, Biochemistry, or a related field with a minimum of 8 years of experience in biopharmaceuticals, demonstrating a solid technical background in bioanalytics; or MS/BS in Chemistry, Biochemistry, or a related field with at least 10 years of relevant experience.
- Proven experience in designing and managing bioanalytical studies for protein therapeutics.
- Expertise in developing, validating, troubleshooting, and maintaining bioanalytical methods for recombinant protein therapeutics.
- Demonstrated ability to establish assays for PK, ADA, Nab, and biomarkers.
- Strong technical proficiency in ligand-binding assays, LC-MS, and other bioanalytical techniques.
- Experience in authoring and reviewing methods, validation protocols, reports, and regulatory submissions.
- Thorough understanding of international regulatory guidelines pertaining to bioanalytical methods.
- Experience in managing CROs effectively.
- Familiarity with recombinant protein characterization is highly advantageous.
- Exceptional interpersonal skills and a proven ability to thrive in a team-oriented environment.
At Vera, base pay is just one component of your total compensation package. The successful candidate will also be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics provides a comprehensive benefits package, including medical, dental, and vision insurance, 401k matching, flexible time off, and several paid holidays.
Notice to Recruiters/Staffing Agencies:
Recruiters and staffing agencies are not permitted to contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from reaching out to our hiring managers, executive team members, or employees. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Any unsolicited resumes submitted by a vendor organization to this website or employee will be considered unsolicited, and Vera Therapeutics will not be responsible for any related fees.
