Job Description

Principal Scientist and Lead of Process Technology - Pharma

• Provide technical process support and expertise for the scale up and/or transfer in of new products and/or process changes due to materials, equipment, or other environmental factors
• Design and validate new process from scale up and optimization to process validation
• Lead the pharmaceutical technology team and provide decisive technical support to commercial manufacturing
• Be the owner of a process throughout its lifecycle
• Lead efforts in identifying critical material attributes and cirtical process paramters, propose in process control and monitoring parameters as well as drug product specifications, advise and implement control strategies for the drug quality
• Steer and implement technology from R&D to scale up and process validation
• Directly communicate with the R&D team, take the ownership for the technical transfer and knowledge sharing toward submission batches for regulatory filing and approval
• Identify opportunities or implement changes to improve products and processes or reduce costs using knowledge of manufacturing processes, tooling and production equipment, packaging methods, quality control standards or product design, materials and parts; provide technical risk assessments and justification documents
• Lead investigations on process and product quality, determine root causes of failures using problem solving and statistical methods and recommend changes in designs, tolerances, or processing methods

• BS or MS in Chemical Engineering, Chemistry, Pharmacy or related scientific field with a minimum of 8 years relevant experience in the pharmeceutical industry or related field
• Familiarity with cGMP, DEA, OSHA, and FDA regulations
• Knowledge of requirements for post approval changes, and current process validation guidances needed
• Good understanding of the current pharmaceutical technologies and manufacturing equipment; technology transfer and scale-up, testing, validation, and packaging
• Experience with pharmaceutical manufacturing processes and equipment

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