Brisbane, CA, 94005, USA
9 hours ago
Clinical Supply Chain Manager
Title: Clinical Supply Chain Manager Location: Brisbane, California 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: The Clinical Supply Chain Manager will report to the Director of Clinical Supply Chain and will be responsible for carrying out operational activities of the clinical supply chain including logistics, manufacturing, distribution and inventory management of clinical supplies. Working with third-party packaging suppliers, Regulatory Affairs, Quality Assurance, CMC, and the Clinical Operations team, this position will be responsible for ensuring uninterrupted supply in the clinical trials. Responsibilities: * Manage global logistics activities for cold chain GMP materials including the scheduling, tracking, import / export, and trade compliance requirements. * Implement and maintain shipment request process and systems to track and monitor shipments. * Creation of shipping documents: Packing Slip, BOL, SLI, Proforma/Commercial Invoice and reports for inbound/outbound shipments. * Maintain inventory management activities across manufacturing sites, warehouses, and key internal stakeholders to ensure accurate and consistent inventory is maintained. * Work with Clinical Operations to define the supply strategy for clinical study investigational medicinal product (IMP) in line with the study protocol. * Forecast IMP demand for global studies based on clinical study protocol and clinical study plan. * Works as part of a team with other members of CMC to ensure on-time delivery of IMP and adequate inventory levels of clinical supplies for the entire duration of the trials. * Create, monitor, and adapt supply plans to supply clinical study demand. * Initiate and oversee the generation, proofing, and translation of clinical study labels, as required. * Oversee IMP shipments within the global distribution network for each trial and prepare documentation for import and export of clinical supplies to depots and study sites, as required. * Coordinate drug returns from site back to depot and perform study drug reconciliation at study closeout. Qualifications: * BA or BS degree in business or life sciences * 5+ years of experience in pharmaceutical industry, logistics management or related field * Direct experience working on supply and distribution aspects for phase 1-3 clinical trials * Working knowledge of Good Manufacturing Practices (GMP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP) is required * Strong computer, database, and organizational skills * Cold Chain experience required * Experience with IXRS systems preferred 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 $99,000 - $127,000. 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. 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.
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