Research Associate require at Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.

Post : Research Associate III

Job Description :
Summary :
This section focuses on the main purpose of the job in one to four sentences.
Extractables and Leachables Subject Matter Experts (SMEs) within the New Product Development (NPD) organization take ownership of the E&L strategy for a diverse product portfolio within the Pharmaceuticals Global Business Unit (GBU), interacting with numerous global cross-functional internal partners (Regulatory Affairs, Pre-Clinical Toxicologists, Device Engineers, Formulation Scientists & Quality) as projects progress from concept to launch and on-market support.
We now have a vacancy for an analytical scientist with proven expertise in chromatographic and mass spectroscopic techniques, applied within a highly regulated environment. The successful candidate will be recognized for their strong analytical expertise and awareness of E&L, taking on the role of an Extractables/Leachables Subject Matter Expert (SME) within the Pharma E&L team. In this role, the successful candidate will have responsibility for the oversight of all project related activity, managing key stakeholders and customers and collaborating with a multidisciplinary team of subject matter experts to develop, execute and summarize the E&L strategy within global regulatory dossiers. The data generated plays a pivotal role in demonstrating the safety of the materials used to manufacture, package and deliver drug products within the Pharma portfolio.

Essential Duties and Responsibilities :
This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
• Point of contact for the Extractable & Leachable team
• Oversight and management of a diverse range of projects of high complexity
• Applies practical and theoretical expertise in chromatographic (GC and LC), spectroscopic and mass spectrometry techniques to develop and execute non-routine experimental protocols
• Interfaces with internal partners to interpret complex analytical data; including quantitation, structural elucidation and toxicological assessment
• Authors and reviews a variety of technical reports, protocols, and regulatory dossiers

Candidate Profile
• Experienced (5 – 7 years) analytical chemistry with strong technical background in chromatographic (GC & LC) techniques coupled to a Mass Spectrometer.
• Good understanding of Extractables/Leachables & the regulatory expectations for parenteral drug products
• Can comfortably handle ambiguity, risk and uncertainty; can decide and act without having the total picture.
• Ability to design experiments and draw meaningful conclusions from lab data.
• Bachelor's degree in a scientific discipline with at least 5 years of relevant experience, MS with at least 3 - 5 years, or PhD with 0 - 3 years of relevant experience.

Additional Information
Qualification : MS or PhD
Experience : 5 – 7 years
Location : Ahmedabad, Gujarat
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th August, 2022