Biological Product Design Owner

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Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Courage
Action Oriented
Collaborates
Cultivates Innovation
Manages Ambiguity
Drives Results

Biological Product Design Owner

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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.

Recruitment Fraud Notice

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Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

“For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.”

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

“I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.”

Meet Amitha, Research Associate in India

“Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Biological Product Design Owner

Overview

Success Profile

Biological Product Design Owner

Address

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Hear from Our Employees

Meet Reagan, Senior Research Scientist in the United States

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

Meet Amitha, Research Associate in India

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Join Our Talent Community