Senior Manager, Packaging Engineering

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ 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 (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell–mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. 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 Senior Manager, Packaging Engineering will report to the Associate Director, Biologics Product Development and will be responsible for packaging engineering, development, and qualification. Working with the CMC team and key personnel including Quality Assurance, Supply Chain, Regulatory and Marketing/Commercial Strategy, the ideal candidate must be an outstanding leader with a proven track record of execution in biologics combination product packaging, having supported packaging development and management of lifecycle changes of commercial packaged goods. In addition, the role requires experience with shipping validation, including transport qualification of Vera’s temperature-controlled supply chain (i.e. Drug Substance, Drug Product, Finished Goods, raw materials, components), and global label/artwork management. The candidate must have exceptional organizational and communication skills, be capable of communicating strategic plans to upper management, summarize data, and effectively manage interactions with stakeholders across functions. Responsibilities: Develop and optimize packaging solutions for drug/device combination products, considering factors such as product integrity, stability, regulatory compliance, and patient usability and safety. Conduct packaging material selection and testing to ensure compatibility, protection, and adherence to regulatory standards. Optimize packaging design for efficient manufacturing, labeling, storage, and transportation within the pharmaceutical industry. Manage the shipping validation and transport qualification of temperature-controlled shipment of goods across the end-to-end supply chain. Direct day-to-day project oversight, including projection of material requirements, budgets, and timelines. Collaborate with cross-functional teams to address any vendor-related issues, including non-conformances, quality concerns, or supply disruptions. Conduct risk assessments and develop contingency plans to mitigate potential packaging issues or regulatory challenges. Manage technical oversight and guidance to CMOs for packaging development, optimization, process validation, and cGMP packaging of biologics drug product in support of clinical and commercial supply. Manage the development of printed components artwork partnering with CMC, Regulatory, Marketing, Legal, CMOs and third-party printer/converters. Execute plans in accordance with industry standards, cGMP, ICH, and FDA regulations. Write, update and review relevant sections for regulatory submissions. Prepare, review, or edit cGMP protocols, reports, CMC regulatory and quality documents Qualifications: MS/M. Eng. in relevant life sciences or engineering discipline with a minimum of 5 years of Pharmaceutical/Biotechnology industry experience in cGMP of biologics, or a related field. BS in relevant life sciences or engineering discipline with a minimum of 8 years of Pharmaceutical/Biotechnology industry experience in cGMP of biologics. Biologic/Device combination product development and packaging experience is highly desirable. Experience in managing US/international CDMOs/CTLs. Experience validating and overseeing temperature controlled global transportation lanes. Familiarity with shipping validation including packaging standards (ASTM, ISTA, ISO), container closure integrity (CCI), product quality testing. Working knowledge of FDA and international cGMP regulatory guidelines and submissions. Proven leadership and cross-functional management of CMC-related programs. Track record of successfully driving and managing programs, overcoming challenges, and managing risks. Critical thinking and problem-solving skills with ability to drive risk-based decision making. Excellent communication and interpersonal skills in working across the organization. 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. 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. For this role, the anticipated base pay range is $125,000—$170,000 USD 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.