Job Description

The Sr. Technology Transfer Leader is a Manufacturing Operations subject matter expert that will actively collaborate with quality, regulatory, manufacturing, engineering and global I&D teams. Responsible for project managing the transfer and implementation of projects and technology from development groups to the plant manufacturing site. Responsible for designing manufacturing procedures of varying degrees of difficulty for new or modified products. Responsible for the oversight of the manufacture of development, stability, product validation batches, and cleaning validation/verification studies, as needed. Responsible for the above technology transfer activities related to projects with outside development labs and contract manufacturing customers. Responsible for assisting with and/or coordinating the training of newly hired Technology Transfer Leaders as well as providing direction and support to other staff members within the group. Responsible for the coordination and tracking of routine departmental tasks. Also responsible for providing technical support to manufacturing operations as assigned by management.

The focus of the Senior Technology Transfer Leader is on technical aspects of the department and usually does not have direct report, however this position 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 Senior Technology Transfer Leader will also serve as a source of direction and support to other staff members within the group. The Senior Technology Transfer Leader must also have outstanding verbal and written communication skills because this position interacts directly with multiple departments at the site, regional and global levels.

Salary Range: $84,112 - $133,189

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

• Communicates plant issues and tasks with the project team with respect to scaling up processe s, new equipment and procedures, equipment and process va lidatio n, manufacturing of developmen t, stability, and product validation batche s
• 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. Is expected to be responsible for those new projects with a high level of difficulty.
• Authors master batch records and protocols for the manufacture of development, stabilit y, and validation batches. Translates development findings into manufacturing processes.
• Identifies and implements best practices and procedures designed to provide robust manufacturing processe s
• Provides information and documentation needed for regulatory submissions or responses as require d
• Plant liaison for manufacturing processes to other departments within the site, other business units within the company, and marketing units. Serves as the plant 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. Generate innovative solutions to solving difficult problems that may impact multiple disciplines. Advises management regarding appropriate action.
• Develops and executes necessary investigative studies and validation protocols as required
• Reviews as required various technology transfer documentation with regulatory and other appropriate groups
• Identifies project requirements and facilitates requirements with outside customers and vendors, as required.
• Project manages routine departmental assignments such as project time tracking, APQRs schedules, 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
• Technical reviewer for tables and protocols and final reports (as assigned by manager).
• Tracks and coordinates routine departmental tasks.
• Actively participates in leadership training.
• Serve as a designee in the absence of the Technology Transfer Manager

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, and wellness 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.