About the Role:Provides operational support for the relationships and assigned activities of commercial Contract Packaging Organizations (CPOs) within the company's supply chain network. Actively participates in assigned cross-functional activities relating to commercial packaging at CPO sites. Contributes to activities related to the timely planning, scheduling, manufacturing, and quality control of production operations. Participate in technical discussions and technical review of packaging documentation. Responsible for the strategy, implementation, and management of serialization activities.
Your Contributions (include, but are not limited to):- Collaborate with external Vendors, Supply Planning, Packaging Development and Logistics to ensure on-time and predictable delivery of products and projects at assigned CPOs
- Owns the supplier management process including scorecards and business review meetings to ensure appropriate controls, oversight and monitoring are in place
- Monitor and support TraceLink transaction processing, EPCIS data exchange activities and serialization data integrity
- Develop and implement serialization requirements for new products and ensure compliance with DSCSA regulations
- Reviews pre- and post-production documents and manages the approval process
- Collaborate with packaging development, quality, supply chain and regulatory to implement artwork and lifecycle changes at CPO for the commercial portfolio
- Supports deviation and product complaint root cause analysis and resolution with CPOs
- Supports validation activities at assigned CPOs
- Participates in the preparation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements
- Provides Person-in-Plant coverage at assigned CPOs for critical production activities as/when needed
- Analyzes, identifies and recommends process improvement, and solutions to complex issues at the CPOs
- Partners with Quality Assurance to ensure CPOs are compliant with all cGMP guidelines and company SOP requirements
- Other duties as assigned
Requirements:- Bachelor's Degree in Packaging, Mechanical, or Materials Engineering or related field and 4+ years of experience in the pharmaceutical development, or technical operations and product quality, focusing on packaging engineering development. Experience in the Biologics and/or parenteral drug product field is a plus OR
- Master's Degree or higher in Packaging, Mechanical, or Materials Engineering or related field and 2+ years of experience as shown above
- Experience with Serialization management platforms, e.g. TraceLink
- Understands key business drivers and uses this understanding to accomplish work
- Proficient with tools and processes that support work conducted by functional areas
- Ability to work as part of a team
- Excellent computer skills
- Strong communication, problem-solving, analytical thinking skills
- Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
- Strong project management skills
- Demonstrated success in project planning, resource management, and collaboration with Development, Quality, Regulatory, and CMC
- Expertise in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices
- Strong knowledge of biotech/pharma manufacturing operations, and product and process development
- Familiarity with document management platforms, e.g. Veeva
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The annual base salary we reasonably expect to pay is $97,000.00-$133,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
