Associate Director, Packaging Engineering and Commercial Labeling

Deciphera - Waltham, MA

Full-time - Mid Level

Remote - Waltham, MA

Professional, Scientific, and Technical Services

About the position

We are seeking an Associate Director, Packaging Engineering and Commercial Labeling, who will be responsible for leading and managing the global packaging and labeling service for Commercial Supply, including activities related to new product introductions. This role will work with our packaging vendors, to define commercial packaging, product labeling and critical package requirements for new commercial products and potential changes or process improvements in our current commercial product. This position will also be responsible for overseeing the operational aspects of commercial supply labeling, including serialization, label copy, draft labeling, proofreading, electronic and hard copy file maintenance, and distribution of approved materials. The position will be required to work closely with several functional departments including Technical Operations, Commercial Operations, Marketing, Quality Assurance, Regulatory Affairs and Third-Party Vendors, CMOs (Commercial Packaging Vendors and Print Vendors). This position will report to the Director, Supply Chain Operations and may be a remote position or located in the Waltham, MA office.

Responsibilities

• SME in packaging and labeling, ensuring proper packaging operations are established for our vendors, packaging specifications and draft labeling specs
• Develop, lead, and implement optimal packaging solutions along with ensuring proper testing and analysis to assess the packaging's performance, including durability, safety and environmental impact, globally.
• Work with our commercial label vendor to manage the creation and revision of labeling for product labels globally, packaging materials, and instructions for use that meet medical, legal, and regulatory requirements.
• Work with Regulatory Affairs and Quality Assurance on label copy changes and inventory management of packaging material post approval.
• Responsible for proper serialization coding, barcoding and GTIN numbers globally, per current regulations and standards.
• Develop, establish, and maintain global packaging standards (die lines, process, compliance) leveraging internal and external capabilities.
• Manage the specifications, pack specs, change controls, version controls and SOPs related to commercial packaging and labeling.
• Manage day to day activities with our commercial packager(s).
• Work with MS&T DP on development of new packaging components for late-stage programs.
• Assist regulatory team with NDC coding, NDA module writing, draft labeling process and monitoring FDA and global guidelines and requirements for label control.
• Lead and manage technical transfers, validations and qualifications of packaging lines, new CPOs or site to site transfers.
• Work with the commercial packager to determine appropriate batch size and process improvements.
• Set commercial packaging KPIs.
• Manage QBR's etc., and building vendor relationships
• Participate in new packaging vendor selection process
• Implement validation of the supply chain MRP system in Oracle

Requirements

• AD/BA in Engineering (packaging preferred) and equivalent with 5+ years with direct GMP experience
• Direct experience in pharmaceutical or device packaging preferred.
• Working knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Packaging and Labeling.
• Proficient knowledge packaging and labeling applications, Oracle ERP as well as Microsoft Excel, PowerPoint and Project software required.

Nice-to-haves

• Understanding of commercial pack out designs and serialization
• SME in packaging operations, blisters preferred
• High attention to detail and demonstrated ability to manage multiple critical path projects concurrently
• Ability to develop, implement and monitor a metrics performance package for labeling and packaging activities
• Demonstrated understanding of quality management and documentation systems - especially as related to change control process and product specifications
• Demonstrates flexibility through adapting to external environment influences through development of new strategies and tactics
• Excellent communication and influencing skills, strong collaboration skills

Benefits

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Monthly cell phone stipend
• Internal rewards and recognition program
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance for family
• Short and Long Term Disability insurance
• Health savings account with company contribution
• Flexible spending account for either health care and/or dependent care.
• Family planning benefit
• Generous parental leave
• [if applicable] Car allowance