Biological Product Design Owner

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.

Essential Duties and Responsibilities

• Achieves desired technical outcomes through the indirect management of individuals and teams(s) and the direct completion of complex Design Control, Corrective Action Preventative Action (CAPA), Change Control (CC) projects or programs within the boundaries of timing and budget.

• Based on significant technical expertise, reviews and approves complex design changes with technical staff (SMEs)] and provides technical product direction.

• Provides technical and design-leadership.

• Fosters an environment of rigor, completeness and compliance when participating on plant CAPA, CC or Field Corrective Action investigations/assessments.

• Responsible for technical and project management of a constantly changing initiative portfolio that are Operations, Quality Systems (QS), Process, Customer or Supply Chain-based.

• Responsible for triage escalation to global R&D team members and managing stakeholder expectations regarding timing and deliverables.

• Responsible to external authorities on design/product specs/product requirements.

• Risk Based LCM and playbook utilization, TMV development and/or transfer, formulation development, process development, tech transfers.

• Generates innovative technical solutions to complex product-related problems through the use of multiple disciplines and technical principles.  Provides guidance for robust use of DMAIC and critical-thinking. Familiar with use of and improvement to playbooks. Creative use of innovative products/processes/methods.

• Maintains current knowledge of relevant QS Regulations and other regulatory requirements related to product development, design and safety, and risk reduction to ensure compliance in all research, data collection and reporting activities.

Qualifications ​

• Relevant technical discipline, preferably an advanced degree in Chemistry/Biology/Chemical Engineering or equivalent

• 1 up to 5 years of experience with a Bachelor degree or 0 up to 2 years of experience with a Master degree.

• Excellent communication skills – both written and oral. 

• Ability to work effectively independently and in team environment.

• Familiarity with applicable quality and regulatory standards for medical devices, drugs and biologics.

• General working knowledge of standards related to design control, change control, CMC, material qualification, process qualification, validation, and risk management, for biologic drugs.

• Comfortable in analyzing and solving complex problems within a risk-based approach

• Aptitude in managing cross-functional, cross-facility teams and projects of a diverse nature

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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