Research Associate II

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:

• HPLC (High-Performance Liquid Chromatography)

• GC (Gas Chromatography)

• LC (Liquid Chromatography)

• KF (Karl Fischer Titration)

• MS (Mass Spectrometry)

• FTIR (Fourier Transform Infrared Spectroscopy)

• 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:

• Quality management systems (QMS)

• Project management methodologies

• Ability to analyze and solve complex problems through innovative thinking and experience.

• Strong project management skills, with experience in:

• Reviewing study protocols and reports

• Managing technical packages and associated documents

• 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.

Industries:Hospital & Health Care, Medical Practice, Pharmaceuticals