Senior Manager, Packaging Engineering
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Requirements
• 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.
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
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