Supervisor, Tech Transfer

Fresenius Kabi USA; Kansas; On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Health benefits

Dental and vision coverage

Wellness program

Job summary

Fresenius Kabi USA in Kansas is seeking a Supervisor to lead the Technology Transfer team, supervising 3-4 direct reports and maintaining development plans. The role acts as a coordinator of routine departmental tasks and supports training of new staff.

The Supervisor will serve as a source of direction for staff across the site and corporate levels, requiring outstanding verbal and written communication skills to interact with multiple departments.

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.
• Project manages all projects related to new products, product modernization and all product transfers.
• Communicates with various plant departments, other support departments, project team members, and own department as needed.
• Reviews and approves documents for direct reports and other team members, and authors documents and protocols as needed.
• Translates development findings into manufacturing and cleaning processes; identifies and implements best practices.
• Provides information and documentation for regulatory submissions as required; reviews CMC submissions as the site representative.
• Acts as point of contact for manufacturing questions and issues; assesses changes through appropriate review and testing results.
• Provides technical support for Investigations, Action Plans and Change Requests as required.
• Reviews technology transfer documentation with regulatory and other groups; coordinates requirements with internal and external customers and vendors.
• Coordinates, tracks and reports routine assignments such as project time tracking, Product Modernization and CPP monitoring.
• Assists in training new employees to the Technology Transfer department; provides first level support to staff.
• Serves as a designee in the absence of the Technology Transfer Manager; acts as technical reviewer for tables and protocols and final reports.

Job description

Job Summary

The Supervisor reports to the Technology Transfer Director. 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 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 - $103,528

Position is eligible to participate in a bonus plan with a target of 6% of the base salary.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

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.

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 at‑will, 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.