Baxter Require Research Associate

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

This position is responsible for
• Conducting laboratory testing, not limited to validation, verification, transfer, and registration stability studies. The successful candidate shall possess solid “hands-on” technical abilities, a passion for their work and the impact it has on meeting the needs of patients.
• Effectively contributing technical knowledge and skills to a variety of projects by conducting testing, designing analytical method and experiments.
• Interacting effectively with a variety of disciplines (Quality, Regulatory, External partners etc.).
• Conducting routine research and design experiments, independently developing/evaluating/validating and/or transferring analytical methods.

Essential Duties and Responsibilities :
• Collect information for the analytical target profile.
• Propose techniques and develop analytical methods independently.
• Design studies and write protocols, reports, and procedures with minimal guidance.
• Evaluation, validation, or transfer of analytical methods, including investigating failed acceptance criteria.
• Contribute routine scientific knowledge or expertise to research and development activities for achievement of project goals.
• Evaluation of current methods and devise new approaches through adaptations and incorporation of new technologies to meet business objectives such as quality and cycle-time.
• Independently conduct routine research and developmental activities. Plan details of assigned tasks within specific parameters.
• Employ appropriate techniques and methods to successfully conduct assignments within negotiated deadlines after receiving general instruction.
• Perform laboratory testing in a regulated environment.
• Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks.
• Develop knowledge and understanding of GxP and related regulations and guidance.
• Conduct R&D stability testing as per the stability protocol to support registration of R&D Product.
• Independently execute analytical method validations and transfers with minimal support.
• Accurately test the samples (Right First Time) and assess results for conformance to specifications.
• Manage Laboratory investigations (OOS/OOT), Nonconformance/deviations to identify sound scientific root cause to follow the implemented corrective and Preventive actions.
• Sample receiving and data entry in LIMS.
• Adhere to cGxP requirements (ALCOA+), Data Integrity, Quality Culture and Compliance Level. Own SOPs of relevant techniques / procedures.
• Advise and troubleshoot issues and propose solutions.
• Maintain lab equipment and report on malfunctions.
• Good knowledge of laboratory health and safety standards.
• Demonstrate the ability to identify risks, issues, and identify opportunities for improvement of existing processes, technologies, and approaches by providing sound scientific rationale.
• Maintain knowledge of relevant QSR and other regulatory requirements related to R&D to ensure compliance in all research, data collection and reporting activities.
• Collaborate with global teams across various functions (ex. quality, regulatory, operations, manufacturing, etc.).
• Analyze data, make decisions, and present status at technical review meetings.

Candidate Profile
Master’s with 9-12 years of relevant experience in a relevant scientific subject area.
Additional Information
Experience : 9-12 years
Qualification : Master’s
Location : Bengaluru, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th August 2024