The purpose of this position is to lead and manage product transfers for internal and external opportunities at Bausch & Lomb Tampa. This includes management and maintenance of existing external customers, new manufacturing business opportunities, as well as internally developed product transfers. This position provides quotes to customers for all project requests and also manages the supply agreement approval and renewal process. This position is also responsible for the process engineering / validation of new and improved capital equipment.
Management of Process Engineers to support project activities and site goals. Employee development, training, performance reviews, etc.
Manage internal and external technology transfers and maintenance of business projects. Major technology transfer projects are planned for and executed over a period of 2-3 years.
Manage process engineering (engineering studies, process development, PV's, CV's) for new and improved capital equipment.
Lead recurring conference calls with customers and issue meeting minutes as needed.
Lead cross functional teams for investigations as required.
Provides a leading role for the Tampa site and collaboratively works with other support groups in the MRB process to assess, recommend and implement technical resolutions to investigations, non-conformances, and OOSs/OOTs.
Provide quotes and manages project budgets for new and existing customers for all project requests.
Facilitate the negotiation of new and renewed supply agreements between B&L Tampa / B&L Legal / External Customer.
Works with the broader Engineering team to recommend and implement manufacturing equipment changes when necessary.
Works with the Validation and Quality groups to implement improvements to the product requalification subsystems.
Reviews and approves documentation (Quality by Design, Process Validation, etc.) related to process capability of new products to assure they are developed with robust manufacturing capability.
Ensures project compliance to all local, state and federal regulations.
Supports department goals and Business Operational initiatives. All other duties as assigned.
BS or MS in Chemical Engineering related engineering, or physical science degree.
Previous experience with technical transfers required.
Strong technical skills in a cGMP environment.
Good oral and written communication skills.
Project management skills (PMI certification a plus), application of time management, and ability to manage budgets and supply agreements.
Solid understanding of compounding, filling, and packaging manufacturing processes with focus on non-sterile and sterile solutions, suspensions, and ointments.
Be detail oriented, quality conscious, and customer service oriented.
Demonstrated strong leadership skills.