Sr. Manager, Packaging Engineering

  •  

Cambridge, MA

Industry: Biotech/Pharma

  •  

8 - 10 years

Posted 265 days ago

  by    Breeana Cebula

This job is no longer available.

Mid-Size Pharmaceutical company located in Cambridge, MA is growing and looking to bring on board a Sr. Manager, Packaging Engineering! This role will focus on developing clinical and commercial labeling and secondary packaging systems, establishing contract packaging organizations (CPOs), and qualifying cold-chain shipping solutions. Will work closely with Global Supply Chain, QA/QC, Technical Development, Regulatory Affairs and CMC teams to implement new processes and manage changes. Otherresponsibilities include:

  • Developing secondary packaging and labeling solutions for clinical and commercial products
  • Validating labeling and packaging operations
  • Partnering with CPO?s to ensure performance and control over their cGMP operations
  • Technical support of cGMP operations for clinical and commercial processes
  • Responsible for coordinating with internal teams and CPOs while managing tech transfer of validated commercial packaging processes and process improvement initiatives
  • Develop, specify and qualify cold-chain shipping solutions for passive and active shipping systems
  • Authoring of technical protocols, reports, and regulatory submissions
  • Implementing global product serialization requirements (DSCSA, FMD, etc.)
  • Developing a deep understanding of current and future external supply needs and ability to clearly link supplier utilization to overall strategy
  • Be the person in-plant during validation activities and routine production as necessary
  • Develop rigorous strategies to reduce costs and supply risk through disciplined analysis, analytics, trending and modeling of key operational data
  • Developing tools, processes, and criteria to evaluate supplier performance

Requirements:

  • BS required in Engineering or related scientific discipline
  • 7+ years of pharmaceutical, chemical, or related industry experience
  • Experience with packaging development, label development, labeling and packaging operations, as well as experience managing contract packaging organizations. 
  • Experience qualifying cold-chain shipping containers (preferred).
  • Experience with CAD, Adobe Illustrator and InDesign
  • Domestic and international travelrequired
  • Candidates must be authorized to work in the U.S.

$90K - $130K