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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.
Job ID: 15296 Direct Hire MA
Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area. This is with a mid-size company and they have a culture that can't be beat. Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer.
The main function of this role is to lead several critical functions at the company as they prepare for commercialization. These include Manufacturing Sciences, Validation, Emerging Technologies, CMC Project Management, and Process Engineering.
Responsibilities include but are not limited to;
• Build out technical functions to manage manufacturing process ownership of launched products, technology transfer, and manage the execution of process validation activities.
• Drive the strategy for technical support and life-cycle management of our late-stage manufacturing processes
• Facilitate/lead tech transfers for early and late stage clinical programs to/from CMOs or internal manufacturing.
• Identify risks and drive continuous process improvement through technological innovation.
• Lead an established team of high performers and grow the department to meet the needs of launching several commercial cell and gene therapy products.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS degree or higher in Engineering or a relevant life science. Advanced degrees welcome. Must have demonstrated experience leading a diverse technical organization as well as external manufacturing providers and partners. Cell therapy and/or gene therapy experience not required but welcome. Must have experience successfully managing manufacturing sciences or process development functions in complex biological processes. Preference given tothose with a track record of successfully supporting biologics programs through late-stage clinical development into commercialization.
Relocation assistance is available. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.