Technology Transfer Lead - Process Scale-Up & Training

Fresenius Kabi; Town of Grand Island (NY); Presencial; USD 74 000 - 103 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k)

Resumo da oferta

Fresenius Kabi is seeking a Supervisor in Technology Transfer to lead a 3-4 person team and coordinate routine department tasks. You will train new employees and support cross‑functional staff to translate development findings into scalable manufacturing and cleaning processes.

The role requires a Bachelor's in Science/Engineering, 5–7 years in product development or technology transfer, and strong English communication. An Equal Opportunity employer with a comprehensive benefits package.

Qualificações

• Minimum of a Bachelor's Degree in Science, Engineering or equivalent experience.
• Must possess good interpersonal skills to establish working relationships.
• 5-7 years experience with product development, process scale up, or technology transfer assignments.
• Six Sigma Greenbelt Certification preferred.
• Knowledge of parenteral product development, manufacturing process, validation, cGMP's, and FDA regulations.

Responsabilidades

• Supervises the daily activities of direct reports and supports other members of the Technology Transfer team.
• Leads the Technology Transfer Team by communicating plant issues and tasks with respect to scaling up processes, new equipment and procedures, equipment and process validation, manufacturing of development, stability, cleaning and product validation batches.
• Project manages all projects related to new products, product modernization and all product transfers.
• Reviews and approves documents for direct reports and other team members.
• Translates development findings into manufacturing and cleaning processes.
• Identifies and implements best practices and procedures designed to provide robust processes for manufacturing and the Technology Transfer Team.
• Provides information and documentation needed for regulatory submissions or responses as required.
• Point of contact for channeling all manufacturing related questions and issues for resolution.
• Technically assesses changes in manufacturing through appropriate review of documentation and testing results.
• Provides technical support for Investigations, Action Plans and Material Change Requests, etc.
• Reviews as required various technology transfer documentation with regulatory and other appropriate groups.
• Coordinates, tracks and reports on routine departmental assignments such as project time tracking, Product Modernization and Continue Process Validation monitoring as required.
• Assist in the training of new employees to the Technology Transfer department.

Conhecimentos

Interpersonal skills

Formação académica

Bachelor's degree in Science/Engineering

Descrição da oferta de emprego

Fresenius Kabi is seeking a Supervisor in Technology Transfer to lead a 3-4 person team and coordinate routine department tasks. You will train new employees and support cross‑functional staff to translate development findings into scalable manufacturing and cleaning processes.

The role requires a Bachelor's in Science/Engineering, 5–7 years in product development or technology transfer, and strong English communication. An Equal Opportunity employer with a comprehensive benefits package.