Research associate ii

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.

Summary:

The new collaborator will be instrumental in driving the success of Baxter's Reference Standard Global Program (RSGP) by leveraging their expertise in method development, method transfer, validations, stability studies, LIMS, and problem-solving capabilities, in close collaboration with a Contract Research Organization (CRO) partner.

Essential Duties and Responsibilities

Technical Expertise

* Serve as a Technical Subject Matter Expert (SME) for Reference Standard development and continued suitability studies, ensuring the highest quality and compliance standards.
* Develop, transfer, validate, and stabilize analytical methods, leveraging expertise in laboratory operations and quality management.
* Manage laboratory documentation to ensure compliance with quality standards, adhering to regulatory guidelines such as ICH, USP, and EP.

Scientific Analysis and Interpretation

* Assess and interpret scientific data, presenting results in a clear, concise, and actionable manner.
* Collaborate with cross-functional teams to drive business decisions and optimize operational efficiency.

Leadership and Collaboration

* Effectively manage CRO resources, including staff, facilities, and budgets, to achieve business objectives.
* Foster a culture of continuous improvement, applying best-demonstrated practices and seeking regular input and feedback from customers.
* Implement metrics to measure quality and on-time delivery, ensuring timely and effective completion of tasks to meet business milestones.

Professional Development and Network

* Build a professional network within the Business Unit, across Units, and outside of Baxter, driving collaboration and knowledge sharing.
* Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements, performing risk/benefit analysis for project identification and prioritization.

Quality and Compliance

* Adhere to the Quality System, understanding and applying applicable corporate, divisional, and departmental procedures to ensure compliance and quality standards.
* Demonstrate a commitment to quality and compliance, driving a culture of excellence and continuous improvement.


Technical Expertise

* Proven background in a range of analytical techniques, including:
o HPLC (High-Performance Liquid Chromatography)
o GC (Gas Chromatography)
o LC (Liquid Chromatography)
o KF (Karl Fischer Titration)
o MS (Mass Spectrometry)
o FTIR (Fourier Transform Infrared Spectroscopy)
o NMR (Nuclear Magnetic Resonance)
* Strong understanding of scientific disciplines, including the ability to review documents and provide guidance to technical staff.
* Demonstrated leadership skills, with the ability to drive decisions and motivate teams.
* Excellent communication skills, with the ability to effectively convey complex information to various stakeholders.
* Strong negotiation skills, with the ability to influence others internally and externally.
* In-depth knowledge of quality and general business systems, including:
o Quality management systems (QMS)
o Project management methodologies
* Ability to analyze and solve complex problems through innovative thinking and experience.
* Strong project management skills, with experience in:
o Reviewing study protocols and reports
o Managing technical packages and associated documents
o Handling stability studies using LIMS (Laboratory Information Management System)
* Ability to analyze and interpret complex data, with a focus on delivering high-quality results.
* Self-motivated and proactive, with excellent interpersonal skills and a strong ability to work independently.
* Proficient in project management tools and techniques, with a focus on delivering results in a timely and efficient manner.

Educational Qualification

* Ph.D. degree in Analytical / Organic chemistry or pharmaceutical sciences with a minimum of 5 years or Master in Analytical / Organic chemistry or pharmaceutical sciences with a minimum of 10 years of experience in technical lead role.
* Experience in Project management and CRO collaboration is an added advantage.

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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