Senior Technical Transfer AssociateReq # JR - 034713 Location Bloomington, Indiana, United States Job Category Manufacturing Date posted 05/12/2021
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
The Senior Technical Transfer Associate is a member of the core project team that is directly responsible for new drug product introduction, process design and development, and process performance qualification (PPQ) for sterile parental drug products intended for commercial production. The Senior Technical Transfer Associate interacts directly with Client Representative, Program Management, Engineering, R&D, Supply Chain, and Manufacturing to ensure an optimal aseptic manufacturing process design is implemented and properly challenged in preparation for process validation activities. This role provides exemplary customer service to both internal and external customers by focusing on design optimization and regulatory compliance. This position reports to the Senior Manager of Technical Transfer.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):
- Primary Focus is on New Product Transfers into the facility
- Product Transfers may include Liquid Vial Projects, Pre-filled Syringe Projects, Cartridge Projects, and Lyophilized Projects
- Lead Technical Owner/Contact for Stage 1 Process Validation activities, such as (but not limited to):
- Process Design/Product Path Equipment Selection
- Formulation Design and Mixing Studies
- Fill Volume Dosing Evaluations
- Product Filtration Studies
- Responsible for supporting Stage 2 Process Validation activities, such as establishing the process design space for performance qualification and ensuring successful execution of process validation activities
- As a process design subject matter expert (SME), responsible for providing commercial manufacturing support when problem solving and trouble-shooting are required.
- Ability to provide real-time subject matter expertise in specific aseptic processing activities
- Ability to design, write, and execute Technical Services Studies and Non-Conformance Reports (Investigations)
- Ability to lead technical discussions with external and internal client teams, and support regulatory audits involving specific process designs
- Responsible for specific operator training and support related to process designs
Job Requirements (Education, Experience and Qualifications):
- Bachelor’s degree required, preferably in a science or engineering related field.
- 5 or more years manufacturing experience, preferably in pharmaceuticals manufacturing; 2 years technical project management experience
- Familiar with quality operating GMP procedures and regulatory requirements pertinent to pharmaceutical drug and biologic manufacturing
- Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization.
- Strong organizational skills (attention to detail) and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently.
- Ability to gowning qualify for Grade A/B areas.
- Computer proficiency in Microsoft Word, Excel, Outlook, MiniTab, and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
Physical / Safety Requirements:
- • Duties may require overtime work, including nights and weekends
- • Use of hands and fingers to manipulate office and production equipment is required
- • Position may require sitting or standing for long periods of time.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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