Baxter Biotech Research Associate Job Opening – Biochem Apply Online
Baxter Biotech Research Associate Job Opening – Biochem Apply Online. Interested and eligible applicants can check out all of the details on the same below:
Research Associate I (PreClinical, Pharma RnD)
Req #: JR – 137109
Location: Ahmedabad, Gujarat, India
Job Category: Research and Development
Date posted: 06/06/2024
Overview
This is where new knowledge is discovered. Baxter’s Research and Development teams work cross-functionally to innovate, develop, and introduce creative solutions for patients’ needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.
- Support for Parents
- Continuing Education/Professional Development
- Employee Health & Well-Being Benefits
- Paid Time Off
- 2 Days a Year to Volunteer
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Success Profile
What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
- Courage
- Action Oriented
- Collaborates
- Cultivates Innovation
- Manages Ambiguity
- Drives Results
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Research Associate I (PreClinical, Pharma RnD)
This is where you save and sustain lives.
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work
makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Position Title – Research Associate III (Pre Clinical, Pharma R&D)
Job Location – Ahmadabad
About Us: Baxter’s Mission
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we build a place where we are happy, successful and encourage each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Your Role at Baxter
This is where your work saves lives.
As a research scientist in this role, you will have expertise in toxicology including design, development and monitoring of toxicity studies, evaluation of extractables and leachables from drug/drug packaging systems, assessment of drug product impurities, and authorship of toxicological risk assessments.
The successful candidate will have hands-on experience in hazard evaluation of chemical entities, and impact assessment of manufacturing or supplier changes, as well as participate in preparing reports for external regulatory bodies in accordance with ICH and ISO guidelines/standards.
Job Responsibilities:
- Design, plan, and supervise various outsourced in-vitro and in-vivo GLP toxicity studies, perform risk/safety assessment (risk assessment and qualification of impurities, leachables, extractables, residual solvents, and excipients) related activities with some supervision from the direct manager and senior technical lead(s).
- Independently author toxicological risk assessments in accordance with ICH and ISO guidelines/standards, as well as local regional regulatory guidelines, by applying a multidisciplinary approach to addressing complex issues.
- Work independently on health hazard evaluation of chemicals and develop appropriate strategies for addressing gaps in information, as appropriate. Participate as preclinical/toxicology representative and contribute to core technical team meetings as
- Subject Matter Expert (SME) and provide inputs and lead tasks to be striven for completion of projects with effective partnership and results.
- Maintain and reciprocate current knowledge of relevant regulatory requirements related to toxicology, product development, design, and safety as per Baxter’s business needs.
- Work with Engineering, R&D, Regulatory, etc. teams to develop comprehensive testing strategies.
- Participate in change control management and impact assessment. Propose options, work closely with team members, and develop action plans for problem-solving, product and process improvement.
- Prepare and/or review nonclinical eCTD and PBRER sections and Safety data sheets (SDS). Analyze and address issues related to data gap for toxicity endpoints using in-silico tools (e.g., Derek Nexus and Sarah Nexus) and read across based assessments.
- Preparation and review of the following:
- Toxicological Risk Assessment for extractables, leachables, residual solvents, elemental impurities, impurities, and degradation products.
- Impurity qualification.
- Nonclinical Overview and Summaries (Module 2.4 and 2.6).
- Permissible Daily Exposure (PDE) document.
- Non-clinical section of Risk Management Plan (RMP).
- Coordinate with external CROs to provide oversight to requested activities and collaborate with functional team members as the need arises to ensure timely execution of tasks.
Qualifications:
- The position requires relevant technical knowledge in toxicology. Proven track record to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH guidelines, and ISO 10993. Excellent oral and written communication in English language.
- Use a logical, methodical approach when problem-solving, developing solutions, and making recommendations. Work independently and prioritize assignments to meet project schedules.
- Ability to craft experiments, supervise toxicology studies, interpret the results, and draw relevant conclusions from the data and prepare reports for external regulatory bodies.
Education and/or Experience:
- Master of Medical Sciences/ Veterinary Sciences/ Pharmacology/ Toxicology/ Biochemistry/ Biotechnology (or relevant) with 2-6 years of work experience, or Ph.D. with experience during thesis (&/or Post-doc) e.g., in or equivalent experience in-vitro and in-vivo Pre Clinical pharmacological (preferably sterile injectable/parenteral formulations) and toxicological studies and risk assessment of chemicals, drug packaging systems.
Keywords: Research Associate, Pharma R&D, Toxicology, Regulatory Compliance, Risk Assessment. Baxter Biotech Research Associate Job Opening – Biochem Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
