TECHNOLOGY TRANSFER SCIENTIST

at Fresenius Kabi USA, LLC in Melrose Park, Illinois, United States

Job Description

Job Summary

The Technology Transfer Specialist is responsible for assisting with the transfer and implementation of defined processes for new products to the plant manufacturing site. The position is also responsible for implementing manufacturing procedures for new or modified products with the support of the manager. The incumbent is responsible for maintaining the product life cycle which includes development, stability, process performance qualification and cleaning validation/verification. This position provides technical support to manufacturing operations with limited scope as assigned by management.

Responsibilities

Supports the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, and manufacturing of development, stability, and process qualification batches. Assigned projects will have a limited scope. Assists in preparing the manufacturing site for the manufacture of new products. Communicate as necessary with the various plant departments, other support departments, project team members, and other internal customers. Prepares master batch records and protocols for the manufacture of development, stability, and process performance qualification batches. Works with management to translate development findings into manufacturing processes. Technically assesses manufacturing processes by risk analysis method(s) and uses results to design robust manufacturing processes. Provides information and documentation needed for regulatory submissions or responses as required. Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results. Executes necessary investigative studies to address product deviations and changes to a manufacturing process. Supports product life cycle through execution of continued process verification reports. Supports cleaning validation/verification program by calculating limits, acting as study director for protocols, swab sampling, and evaluating products for cross-contamination. Assesses feasibility of simple research and design concepts related to modernizing a product/product family or enhancing knowledge of a product/product family which includes but is not limited to compatibility studies for tubing, vials, and stoppers, thermal cycling studies, light studies, and studies which support product insert. Consult with senior peers on non-complex projects to learn through experience. Technical reviewer for tables basic protocols and final reports. Updates Standard Operating Procedures based on supporting validation. Perform any other tasks/duties as assigned by management.

REQUIREMENTS
Bachelor's degree in physical science, engineering, or equivalent experience in pharmaceuticals.
Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment.
Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities.
Demonstrate a working knowledge of basic technical theories and principles
Typical work hours are the standard first shift, however execution of protocols will often require work on nights and weekends to meet the production schedule. Flexibility with schedule is required.
Schedule based on a 40-hour work week with the number of hours per day flexible to support protocol execution and production schedule.

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 match, andwellness program.

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.

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, disabilities, or protected veteran status.