Tech Transfer Leader

This position is responsible for new product transfers and process modernization including plant representation in project team meetings; participation in successful stability and validation batch manufacturing; necessary support of the Regulatory submissions and modernization of manufacturing processes. Responsible for Product Validation based on current SOP’s and procedures. Responsible for modifications to existing products, e.g., site transfers, new raw material source qualification, or process modification.

•        Supports activities related to introduction of New Products as it relates to Plant issues, capacities, and capabilities.

·        Supports activities related to successful manufacture of new product or existing product stability and validation batches through coordination and communication of the involved departments.

·        Coordinates the development of the manufacturing process with I&D personnel keeping in mind scale-up issues, process specifications, and operating procedures for new products, new equipment, and technologies for successful product transfer.

·        Plans work schedules to accomplish the required duties in a timely manner according to approved schedules. Participates in various new product team meetings and committee meetings as required to support the process and/or project.

·        Communicates status of progress against goals and objectives to the department and management. Establishes and publishes necessary schedules to assure that the various plant departments are aware of and meet agreed upon product schedules.

·        Develops stability lot master records and participates in lot manufacture to assure reliable transfer of technical information needed to scale up the production batch size master for the CMC section of the ANDA submission or other Regulatory Submissions.

•        Bachelor’s Degree in Science, Engineering, or equivalent related experience.

•        Knowledge of Pharmaceutical technical issues, manufacturing processes, and operations environment including a knowledge of New Product Transfer.

•        Good interpersonal, communication, analytical, and leadership skills.

•        2-5 years of experience preferred.