Duration: 12 Months
Industry: Pharma
The primary responsibilities include:
(1) Makes technical and business-based recommendations on primary, secondary and tertiary package systems and material for both new and marketed pharmaceutical product projects.
(2) Develops test protocols and manages execution of various packaging studies including USP, EP and transport qualification for bulk and finished drug product and packaging.
(3) Acts as technical and coordination focal point for site and external CMO's for multi-site projects regarding technical documentation of package requirements. Define development actives and developed project plans that meet the defined objectives. Acts as Project manager to plan and manage all technical packaging requirements for successful introduction of packages from development stages to commercial market.
(4) Identifies new packaging technologies and/or applications that could improve cost, compliance and quality and/or customer acceptance.
Other support activities may include:
- Develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes. Provide input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
- Responsible for process design and continuous improvements, support execution and documentation of development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition and process validation runs. Document and interpret study results with recommendations. Provide technical leadership as a subject matter expert in multiple areas of responsibility. Document and interpret study results with recommendations.
- Execute life-cycle design and industrialization of upstream processes, products and associated test methods for Phase 3 and licensed products (new vaccines and biopharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals.
- Input to design space/DOE studies through establishment of scale-up/scale-down parameters utilizing engineering fundamentals (mixing, mas /heat transfer, modeling, dimensionless parameters, etc.) and process control strategies. Partner with engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment.
- Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI). Expertise in one or more upstream process unit operation design typically used in biotech/vaccine manufacturing (seed expansion, viral growth and egg processes, harvest/clarification) as well as project/engineering lifecycle.
- Knowledge of computer software common to mission (AutoCAD, process simulation/scheduling, CFD) is preferred. Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control. Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members. Experience in equipment start-up, qualification and validation is preferred. Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering. Advanced degree in sciences with 10+ years’ large scale process equipment design, scale-up implementation & validation experience.
Shift - Day
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