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Summary
This is a key position within AME Process Development of Global Engineering organization. The position will be responsible for process development and tech transfer of parenteral pharmaceutical products and sterile medical devices. The position will play an essential role in global product development teams and interface with Baxter manufacturing plants in the North America and Latin America regions as well as contract manufacturers. The position is located in Round Lake, IL.
Essential Duties and Responsibilities:
- Responsible for evaluation and development of manufacturing processes for parenteral pharmaceutical products and sterile medical devices.
- Participate in multi-disciplinary product development teams to provide manufacturing process input.
- Design and conduct process development studies to scale up manufacturing processes for commercial production.
- Conduct technology transfer from R&D to manufacturing facilities and between manufacturing facilities based on sound laboratory/pilot scale studies and thorough understanding of commercial scale processes.
- Liaise with contract manufacturers to ensure Baxter requirements are met.
- Conduct studies to support regulatory filings or to provide technical justifications for change control.
- Must be able to travel for assignments.
Qualifications:
- Experience with parenteral pharmaceutical products and related scientific and practical knowledge are required.
- Must be familiar with GMP and ICH requirements and have good understanding of Quality by Design (QbD) principles.
- Ability to work effectively in a matrix organization, and good communication and interpersonal skills are highly desirable.
- Proficiency in languages other than English is a plus.
- Must have experience in prioritizing multiple tasks in a fast paced environment.
- BS with 2-4 years or MS with 0-3 years experience is required. The degree should be in chemistry, chemical/biomedical engineering or Pharmacy/Pharmaceutical Engineering.
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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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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