Manu Kittanakere

About Manu Kittanakere

Packaging operations leader with MS in Packaging Science and more than 16 years’ experience in full package development cycle, from concept to design to testing to production, as well as global manufacturing, logistics, and compliance.Recognized packaging SME and innovator in biopharma, pharmaceutical, and medical device space. Leads strategy and operations, guides stakeholders, mentors new engineering talent.Specialist in glass vial shipment with patent for revolutionary glass vial packaging solution. Materials authority on Tyvek, multi-layer film, cryogenic bags, coated paper, thermoformed trays, corrugated shipper, and label materials. Experienced manager of cold chain products, gene therapy requirements, and temperature-controlled packaging. Guide to overseas CMOs, CPOs, 3PLs, and packaging / labeling vendors.Expert in NDA, MAA, and 510K submissions, authored MAA filing packaging and labeling sections for Zynteglo. Experienced in US, EU, and LATAM product launches. Established successful US and overseas operations.Career Highlights:• Patented plastic insert that revolutionized bulk glass tube shipping and preserves 100% of original strength by eliminating microcracking in thousands of tubes caused by conventional packing that reduced strength by up to 50%.• Led $1M buildout of Bluebird Bio R&D Packaging Division, and developed innovative packaging solutions for $750K-per-dose gene therapy medication requiring carefully controlled temperatures across global environments.• Created robust but user-intuitive packaging solution for delicate laparoscopic devices meeting temperature-sensitive sterile conditions, and easily opened without breakage in operating theaters, cutting waste to 0 for 1M units/year.Technical & Leadership Competencies: Packaging Strategy & Operations • R&D • Package Design • Glass Packaging & Shipping • Gene Therapy • Medical Devices • Engineering Leadership • Operations Setup • Process Optimization • Complex Project Management • Global Regulations • Global CMO / CPO/ 3PL Management • International Regulations • Industry Best Practices • Stakeholder Collaboration

Experience

1. Executive Member

   International Leap Network

   Oct 2023 — Present

Education

• Rochester Institute of Technology

  Master of Science - MS, Packaging Science

• B. M. S. College of Engineering

  Bachelor's degree - BS/BE, Printing Technology