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Research Scientist I

Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You'll find Baxter's products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter's employees are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
This position is within the Drug Development R&D organization. The selected candidate will be a PDO (Product Design Owner) and a technical leader within a group responsible for sustaining and continuously improving a broad, global portfolio of premixed drug and other pharmaceutical products.
The individual filling this position will be expected to independently propose, plan, execute, and direct cross-functional team members through the successful completion of multiple concurrent lifecycle management (sustaining, expansion, line extension, quality, etc.) projects within the boundaries of quality, time and budget while driving disciplined application of best practice techniques. They should be able to:
Exhibit creativity and innovation in completing divisional and cross-functional/business unit responsibilities.
Drive continuous product/process improvement, and or operational excellence initiatives.
Provide expertise that encompasses major disciplines outside primary area of discipline or business.
1 .After gaining product specific expertise, serve as an SME (subject matter expert) and PDO (Product Design Owner) on pharmaceutical lifecycle management (sustaining) projects. Incorporate deep knowledge of customer use and product/process design to predict product effectiveness/anticipate potential failures.
2. Ensure that team objectives align with key corporate strategic programs including the relevant global business unit strategy and Product Health Plan. Proactively propose initiatives to improve overall product health.
3. Accountable for successfully meeting agreed upon milestones for key corporate projects. Work closely with the Project Management Organization and global cross-functional teams to develop effective project milestones, schedules and manage budgets, including capital. Identify and resolve issues that may jeopardize project schedules or improve project time.
4. Regularly communicate project status and other topics to a cross functional audience at multiple levels within the organization.
5. Drive the creation and/or update/remediation of compliant yet practical product documentation including: all relevant product file (DHF, DMR) documentation, Change Control plans and assessments, requirements development/ management, test method development/validation, Risk File reviews/updates, and post Design Transfer controls.
6. As required, own or support relevant CAPA projects
7. Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
8. May supervise and direct Research Associates.
Bachelor's degree in a scientific discipline with 10 years' experience, MS with at least 5-7 years, or PhD with 0-2 years in relevant discipline (e.g. chemistry, engineering, pharmaceutical sciences) required. QSR research lab experience essential and GMP experience desirable. Research lab experience includes research in GMP/QSR environment. Participation on cross-functional technical teams and project management experience is also desirable.
1. A solid technical understanding of pharmaceutical product lifecycle management and demonstrated application of knowledge in related scientific disciplines is required.
2. Relevant experience in injectable pharmaceutical product development, (e.g. formulation development or analytical development) and/or lifecycle management is strongly preferred. Previous experience as a PDO (or similar role) is also strongly preferred.
3. Strong leadership potential with a demonstrated eagerness to learn and continuously improve.
4. Demonstrated critical thinking and disciplined problem solving skills. Must be able to provide solutions that reflect an understanding of business objectives and cost implications. Experience driving rapid cross-functional team decision making is required.
5. Experience successfully balancing multiple concurrent priorities within a rapidly changing environment. Relevant product lifecycle management (sustaining) experience is preferred.
6. Strong attention to detail and strong communication skills (both verbal and written) required. Demonstrated experience communicating strategy, project status and technical risks to cross functional audiences including senior management is desired.
7. Ability to work independently or as a collaborative part of a global, cross functional team €“ within and outside of primary area of expertise. Must be able to lead, direct, and/or supervise lower level associates.
8. Demonstrates flexibility and the ability to shift gears between projects comfortably.
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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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.

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