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Role Description

The Senior Manager, Packaging Engineering will report to the Associate Director, Biologics Product Development and will be responsible for packaging engineering, development, and qualification. 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.

• 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).
• Global label/artwork management.
• Exceptional organizational and communication skills.
• Capable of communicating strategic plans to upper management, summarizing data, and effectively managing 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.

Requirements

• Salary range: $125,000 — $170,000 USD.

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