Package Engineering Senior Manager

Job Description

JOB TITLE: Package Engineering Senior Manager  

LOCATION: 50 Northern Ave., Boston, Massachusetts, 02210 

OPENINGS: 1 

DUTIES:  

• Represent department on cross-functional CMC sub-teams, with minimal guidance.  

• Ensure positive and effective relationships with key suppliers of materials, technology, and manufacturing resources.  

• Manage and design key packaging activities including packaging design and specification, equipment and tooling design and qualification, labeling, material selection, testing, and sourcing.  

• Work effectively with multiple stakeholders including Pharmaceutical Sciences, Manufacturing Sciences & Technology, Regulatory Affairs, Project Management, Supply Chain, Quality, Marketing and other cross functional departments to meet project timelines and objectives.  

• Review process performance to identify continuous improvement activities for commercial products.  

• Lead technical transfer and process validation activities; responsible for authoring and reviewing packaging qualification and validation documents.  

• Translate product specifications into Packaging Design Documentation, ensuring enough detail is captured for Process Development and Manufacturing purposes.  

• Work with domestic and international CMO (Contract Manufacturing Organization) to implement packaging solutions for product launch.  

• Prepare definitive specifications or revisions with appropriate testing.  

• Develop packaging systems that align with User Requirements, Functional Requirements, and Regulatory requirements.  

• Manage Change Control, work with Cross-Functional Team for Impact Assessment, and manage timely completion of activities while ensuring updates are made to relevant documents.  

• Support technical aspects of New Product Commercialization by effectively utilizing knowledge and first-generation learnings to design and develop commercial product packaging.  

• With cross-functional input, author and execute study protocols and applicable testing regimens, and document all Root Cause Analysis Reports.  

• Perform technical risk assessment related to packaging design and processes for new and commercial released products.  

Position requires 20% domestic and international travel. Telecommuting permitted up to 40%. 

REQUIREMENTS:   Employer will accept a Bachelor's degree in Packaging, Mechanical, Chemical, or Material Engineering, or a related field and 96 years of experience in the job offered or in a Package Engineering Senior Manager-related occupation. 

Position requires demonstrable experience in the following: