at Fresenius Kabi USA, LLC in Melrose Park, Illinois, United States
Job Description
Job Summary
The Technology Transfer Leader is a Manufacturing Operations subject matter expert that will actively collaborate with quality, regulatory, manufacturing, engineering and global I&D teams. The position is responsible for coordinating the transfer and implementation of projects and technology from development groups and customers to the plant manufacturing site. The incumbent is also responsible for designing non-complex manufacturing processes for new or modified products to ensure robust and reliable product design and manufacturing processes for commercial scale. Th position plans, coordinates, and oversees the product life cycle which includes development, stability, product validation batches, and cleaning validation/verification studies.
Responsibilities
1) Project manages execution of preduct transfer and cleaning projects, as applicable, ensuring they are completed on time, on budget, meet the company goals, and in a manner consistent with regulatory and quality requirements.
2) Leads the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, manufacturing of development, stability, and product validation batches by communicating tasks and an/ issues.
3) Translates development findings into a manufacturing process that can be implemented within the plant.
4) Technically assesses manufacturing processes using FMEA or other risk analysis method(s) and uses the results to design rebust manufacturing processes
5) 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 resolut on.
6) Prepares master batch records and protocols for the manufacture of development, stability, and validation batches.
7) Identifies and implements best practices and procedures designed to provide robust manufacturing processes.
8) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
9) Provides formation and documentation needed for regulatory submissions or responses as required.
10) Provides technical assessment of changes in manufacturing through appropriate review of documentation and testng results
11) Provides technical support for Investigations, Action Plans, Gap Assessments and Material Change Requests, etc. as required
12) Develops and executes investigative studies and validation protocols as required.
13) Reviews as required, various technology transfer documentation with regulatory and other appropriate groups.
14) Project manages routine departmental assignments such as project time tracking, APQRs schedules, Product.
15) Assists n the training of new employees to the Technology Transfer department
16) Provides first level of support ard direction to departmental staff members as required.
17) Technical reviewer for tables and protocols and final reports (as assigned by manager)
18) Creates Standard Operating Procedures based on experience and updates Standard Operating Procedures base on supporting validation.
19) Actively participates in leadership training.
20) All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
MANAGEMENT SCOPE
Manages, mentors and coaches 1 or more employees. Has hiring, firing and performance decision power Manages, mentors and coaches than 3 employees. Has hiring, firing and performance decision power Manages mentors and coaches other employees.
Does NOT have hiring, firing and performance decision power Does NOT manage other employees.
Does NOT have hiring, firing and performance decision power
REQUIREMENTS
* Bachelor's degree in science or engineering required.
* Minimum of three years experience with product development, process scale up, or technology transfer assignments that demonstrates the tenacity to see projects through to completion according to established action plan; analytical skills necessary for problem solving issues as they arise
*Strong interpersonal skills; must be able to interact effectively at all levels of the company
* Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities
* Technical Area of Expertise - GMP manufacturing, equipment and process engineering, quality, product formulating, filling and packaging, sterile manufacturing technique, warehousing, distribution, purchasing, contracting,... For full info follow application link.
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.
