Assoc Scientist I

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Summary:

The new collaborator will be driving the success of Baxters 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 lead for Reference Standard development and continued suitability studies, ensuring the highest quality and compliance.
• Develop, transfer, validate, and optimize analytical methods, leveraging expertise in laboratory operations and quality management.
• Manage documentation by ensuring 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

• Foster a culture of continuous improvement, applying best-demonstrated practices and seeking regular input and feedback from end users.
• 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 and interpersonal expertise

• Proven background in a range of analytical techniques, including: HPLC, GC, LC, KF, MS, FTIR, NMR etc.,

• 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 technical skills, with experience in:
  • Reviewing study protocols and reports
  • Managing technical packages and associated documents
  • Handling stability studies using LIMS
• 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. in Analytical / Organic chemistry or Pharmaceutical sciences with a minimum of 3 years or Master in Analytical / Organic chemistry or Pharmaceutical sciences with more than 6 years of experience.
• Experience in Project management and CRO collaboration is an added advantage.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations
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