Sr. Manager, Packaging Engineering Direct Hire MA
Job ID: 15313 Direct Hire MA
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. Other responsibilities 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
- 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 travel required
- Candidates must be authorized to work in the U.S.