Supervisor, Technology Transfer

Fresenius Kabi USA, LLC; Grandyle Village (NY); On-site; USD 74,000 - 103,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

401K with company contribution

Disability

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a Supervisory role in Technology Transfer located at our site in New York. The incumbent will supervise 3-4 direct reports, develop individual plans, and coordinate routine department tasks and new employee training.

The role requires strong communication with multiple site and corporate teams. The position involves leading technology transfer efforts, project management for product transfers, and ensuring alignment with regulatory expectations.

Qualifications

• Bachelor's degree in science, engineering or equivalent experience.
• 5-7 years of experience in product development, process scale up, or technology transfer.
• Six Sigma Greenbelt certification preferred.
• Knowledge of parenteral product development, manufacturing, validation, cGMPs and FDA regulations.

Responsibilities

• Supervises 3-4 direct reports and maintains development plans for each.
• Leads technology transfer initiatives, coordinates with plant departments and document workflows.
• Projects management for product transfers and modernization, communicates with cross-functional teams.
• Reviews documents, authors protocols and executes validation and manufacturing steps as needed.
• Provides training and technical support, acts as site representative for regulatory interactions.

Skills

Six Sigma Greenbelt

Supervision

Education

Bachelor's Degree in Science or Engineering

Job description

Job Summary

The Supervisor reports to the Technology Transfer Manager. Besides supervising the 3-4 direct reports and maintaining development plans for each direct report. The Supervisor is expected to function as a coordinator of specific routine departmental tasks and assist in the training new employees within the Technology Transfer department. The Supervisor will also serve as a source of direction and support to other staff members within the group. The Supervisor must also have outstanding verbal and written communication skills because this position interacts directly with multiple departments at the site and Corporate level.

Salary Range: $73,614-$103,000 + 6% annual bonus

Responsibilities

• 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. Communicates 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 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 Manger.
• Technical reviewer for tables and protocols and final reports (as assigned by manager).
• Tracks and coordinates routine departmental tasks.
• Actively participates in leadership training.

Requirements

• Minimum of a Bachelor's Degree in Science, Engineering or equivalent experience.
• Must posses 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.
• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

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.