Associate Director, CMC Technical Writer

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s 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. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position Summary:

We seek an experienced technical writer to join a highly talented, fast-paced and collaborative team. This position will report to the Executive Director of Analytical Sciences and will author and review technical and regulatory documents for the chemistry, manufacturing and controls (CMC) function. Working with the CMC team along with other functions including Regulatory, Quality Assurance, Project Management, and with external contract service providers, this position will enable complete, accurate, and clear documents to support Vera’s clinical and commercial programs.

Responsibilities:

• Author and review internal documents including protocols, reports, SOPs, deviations, change controls, and manuscripts in support of all CMC functions.
• Work closely with the members of the CMC and Regulatory functions to author and review regulatory documents including IND/IMPD/BLA/MAA sections and meeting packages.
• Collaborate with CMC, Quality, and Regulatory colleagues to develop story boards for inspections and responses to information requests.
• Review external documents from Vera’s supply chain network.
• Develop document templates and workflows for technical documents.

Qualifications:

• MS in Chemistry, Biochemistry, or related discipline with a minimum of 6 years or BS in Chemistry, Biochemistry, or related discipline with a minimum of 8 years of experience in clinical-stage biopharma with a proven technical track record in technical writing supporting CMC for Biologics.
• Experience authoring and reviewing a diverse set of technical documents including technical reports, manuscripts, regulatory filings including BLA/MAA across a broad technical background (analytical, process development, manufacturing)
• Experience working with contract service providers is a plus.
• Effective communication and documentation skills.
• Strong attention to detail and organization.
• Excellent interpersonal skills and demonstrated ability to work well in a team-oriented environment.
• Candidates must be authorized to work in the U.S.

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