Supervisor, Tech Transfer

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Supervises the daily activities of direct reports and supports other members of the Technology Transfer team. Maintains development plans for direct reports and continually works to develop them to the next level.
• 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. At a minimum, leads one weekly meeting with the team.
• Project manages all projects related to new products, product modernization and all product transfers.
• Communicate as necessary with the various plant departments, other support departments, project team members, and own department.
• Reviews and approves documents for direct reports and other team members. Will also author documents and execute protocols, as needed.
• 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. Reviews CMC submission as the site representative.
• 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. Reports on changes through risk assessments.
• Provides technical support for Investigations, Action Plans and Material Change Requests, etc. as required.
• Reviews as required various technology transfer documentation with regulatory and other appropriate groups.
• Identifies project requirements and facilitates requirements with internal and external customers and vendors as required.
• 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.
• Provides first level of support and direction to departmental staff members as required.
• Serve as a designee in the absence of the Technology Transfer Manager.
• Technical reviewer for tables and protocols and final reports (as assigned by manager).
• Tracks and coordinates routine departmental tasks.
• Participates in leadership training.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.