Senior Manager, Packaging Engineering
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Job Description
Senior Manager, Packaging Engineering at Vera Therapeutics developing packaging solutions for biologics drug/device combination products. Leading project oversight and cross-functional collaboration within the pharmaceutical industry.
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.
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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