Senior Manager, Packaging Engineering

Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. The Senior Manager, Packaging Engineering will be responsible for packaging engineering, development, and qualification, collaborating with cross-functional teams to ensure compliance and efficiency in packaging solutions.

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

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