What are the responsibilities and job description for the Senior Manager, Analytical Sciences position at Vera Therapeutics?
Job Description
Job Description
Job Title : Senior Manager, Analytical Sciences
Location : Remote
About Us :
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 fully humanized fusion protein self-administered at home as a subcutaneous 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 considering 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 are seeking a Senior Manager, Analytical Sciences to join an experienced, fast-paced and collaborative team. The Senior Manager, Analytical Sciences will report to the Executive Director of Analytical Sciences and will support all aspects of our analytical programs for antibody and fusion protein products. Working with the CMC team and key personnel including Quality Assurance, Regulatory, and Project Management, and with external CDMO and contract testing laboratories, this position will ensure timely delivery of investigational product, drive process / product understanding, and enable commercial supply.
Responsibilities :
- Work with external partners to develop, transfer, qualify and validate the analytical methods used for in-process testing, drug substance and drug product release, demonstration of comparability, and stability testing.
- Review raw data and prepare tables / figures for batch release, in-process, and stability testing data for both drug substance and drug product at CMOs / CTLS for comparability assessments, specification settings, and regulatory filings.
- Author and review analytical sections for regulatory filings.
- Review protocols, test procedures, raw data, and technical reports related to late-stage analytical activities such as minor variant characterization, comparability assessments, commercial specification setting, and commercial reference standard qualification.
- Contribute to due diligence activities, gap analysis, deviations, and OOS investigations.
Qualifications :
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. For this role, the anticipated base pay range is $156,000 - $181,000. 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.
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.
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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.
Salary : $156,000 - $181,000
