Sr. Research Assistant - CCE

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.

This position provides support to the Container Closure Engineering Team in technical and operational activities like Trace analysis
(Extractable & Leachables) using Hyphenated Advanced Analytical Techniques such as ICP-MS/OES, GC-MS and LC-MS/MS-MS. The
successful candidate will need to possess sound theoretical knowledge of modern analytical techniques, updated knowledge of current
Pharma industry guidance, excitement and energy for new product development impacting patients world-wide, and good written & verbal
communication skills. A good learning agility will be necessary to innovatively face the challenges encountered during R&D work. Preferred
skills include a hands-on experience in handling UTM, VMM, CCIT, Leak test operates, Vibration tester, drop tester, torque tester and
statistical skills. The incumbent will perform other duties as assigned.
Serving as primary, secondary and tertiary packaging expert on technical development teams to provide the best-in-class
containers, drug delivery devices, cartons and shippers for Baxter Pharmaceuticals products.

Support Innovator pack/ Reference Packages characterization
Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports,
summaries, SOP, protocols, and reports.
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Develop process descriptions to standardize testing procedures. Specify test requirements and acceptance criteria to satisfy
quality and regulatory needs (e.g. Design Verification DV, Process Validation PV).
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Ensure test method qualification and method transfer to GMP testing group in support of verification & validation testing for
primary packaging, secondary packaging and tertiary packaging as per regulatory requirements
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• To take the trails of new packaging materials at manufacturing sites
Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. – USP/PharmEur, ISO
/MDD/GMP/GLP, 21CFR 820.30, ISO 14971 and applicable safety requirements. Prepare and maintain documentation and
formal reports in accordance with these standards
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Define, organize, plan and execute analytical development and characterization activities of pharmaceutical injectables in
compliance with current international/regional/national regulations and guidance (cGLP, cGMP, GDP) with the support of
senior colleagues, own team members, and global cross-functional teams.
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• Work with and interpret data of advanced instrumentation techniques, hyphenated techniques, and other analytical techniques.
Conduct failure analysis, and root cause analysis in new product development and sustaining product projects within specified
timelines, under supervision.
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• Engage in science-based troubleshooting of the analytical issues and product development challenges.
Provide proposals for product development-related innovations, analytical method innovations, and product/process
improvement initiatives in collaboration with senior scientists
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• Ensure good cross-functional communication and collaboration to drive allotted activities to timely completion.
• Preparation of scientific reports, proposals, and presentations
• Perform the calibration and maintenance of laboratory instruments and equipment.
Follow Baxter’s Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day-to-day
activities, to ensure proactive compliance and continuous improvement.

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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