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
Summary :
This Research Associate III position will support stability activities of Medication Delivery Team in the following day to day technical and operational activities: stability planning for new product development (NPD) and to sustain current product line (SPO), directing R&D and commercial stability studies executed in Baxter facilities and at Contract Research Organizations, providing technical rationale for expiration dating and label storage statement recommendations, preparing regulatory submissions, responding to regulatory communications, and ensuring compliance related deliverables are completed on schedule and per plan. Specifically, this position is expected to
Job Description
• Develop stability study designs for new product development and sustaining product projects.
• Contribute to technical feasibility analysis of complex research and design concepts.
• Evaluate results relative to product requirements, definitions and/or program goals.
• Independently plan and execute a series of stability study designs and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
• Play a lead role in the evaluation, selection and adaptation of various techniques/ strategies, which accomplish business objectives such as quality and cycle-time.
• May provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding unique problems.
• Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.
• Maintain current knowledge of relevant QSRs and other regulatory requirements, such as the stability related ICH guidelines, for R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Displays a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise.
• In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
• Develop budgets and activity schedules of limited scope.
• Maintain focus on meeting both external and internal customer expectations.
Candidate Profile
• Masters degree in relevant scientific discipline (chemistry, pharmaceutical sciences – M Pharm, M Sc) with 5-7 years experience or Masters degree with 3-5 years experience or Ph D with 0-3 years experience.
• Possess relevant laboratory/technical, writing, and computer skills specific to stability study design and development. LIMs experience is a plus.
• Utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations.
• Ability to organize, assess and communicate complex information that engages the audience.
• Ability to make decisions when provided with limited information and to make routine decisions independently.
• Ability to articulate customer needs and incorporate into work product.
• Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
• Ability to design experiments and draw meaningful conclusions from lab data.
• Experience in working in global cross-functional teams and project management is a plus.
• Ability to adapt to changes and to work in a team environment.
• Ability to effectively mentor junior level associates.
Additional Information
Location : Bengaluru, Karnataka
Industry Type : Pharma/ Healthcare / Clinical research
Functional Area : Research and Development
End Date : 20th August, 2020
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