Our global pharma client is looking to add onto to their elite Device Development team in the Waltham, MA area and bring on-board a Packaging Manager! This is a role that will have both site and global insight and be a critical influencer on the development and selection of Container Closure Systems for their drug combination devices. This role will manage cross functional teams and develop innovative new primary packaging concepts (CCS), qualify and implement optimal and cost-effective primary packaging solutions that offer best in class process efficiency to operations in the different Operation Sites. In addition, will work very closely with the device development, packaging engineers and drug product groups to coordinate all aspects for primary packaging. Manager will be highly involved with the development and launch of primary packaging components; assess, develop, design, specify, test and implement primary packaging solutions at external and/or internal manufacturing sites. Additional responsibilities include CCIT deliverables and resolving manufacturing issues. Other responsibilities include but not limited to:
- Develop innovative new concepts for primary packaging, qualify and implement CCS solutions
- Manage primary packaging activities including developing, qualifying and implementing of CCS
- Provide guidance to the laboratory for the testing of CCS and development of CCIT methods
- Lead, manage and execute all CCS aspects of a project. Accountable for delivering on specific performance indicators
- Will work with internal stakeholder to create or enhance primary packaging capabilities to deliver the needed quality required by our patients
- Will partner with packaging engineering group to ensure quality in product packaging and drive elimination of customer complaints relating to packaging
- Serve as a Point of contact for Primary Packaging aspects to the Product Technical Teams
- Support protocols development for the feasibility testing
- Recruit and manage external resources, such as, Consultants and Contractors, as needed to deliver projects.
- Represents device development and external manufacturing on
- Investigate new sources and make recommendations on primary packaging materials and support material change and implementation.
- Bachelor’s degree in a scientific/technical discipline with a minimum of 8 years related experience. Applies expert knowledge of scientific/technical principles and concepts in managing technical programs such as Package design development for primary packaging systems
- Familiar with CCIT methods such as dye ingress, head space analysis, vacuum decay, and high voltage leak detection
- Experience in global product launches and the associated CMC regulatory requirements.
- Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations is preferred.