Research Associate II (PreClinical, Pharma R&D)

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Scientist/Researcher in this role will have expertise in toxicology including design development and monitoring of toxicity studys evaluation of extractables and leachables from for drug/drug packaging systems assessment of drug product impurities andauthorship 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 monitor 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 direct manager and senior technical lead(s).

Independently author/review toxicological risk assessments in accordance with ICH and ISO guidelines/standards as well as local regional regulatory guidelines by utilizing 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 executed for completion of projects with effective collaboration and deliverables. Maintain and reciprocate current knowledge of relevant regulatory requirements related to toxicology product development design and safety as per Baxters business needs with team members and cross functional teams. Work with cross functional team members (Engineering R&D Regulatory etc.) to develop comprehensive testing strategies. Participate in change control management and impact assessment. Propose options work closely with stakeholders 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 tool (e.g. Derek Nexus and Sarah Nexus) and read across based assessments. Preparation and review of following:

• Toxicological Risk Assessment (TRA) 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)

Co-ordinate with external CROs to provide oversight to requested activities and communicate with functional team members as required to ensure timely execution of tasks.

Qualifications:

The position requires relevant technical knowledge in toxicology. Demonstrated ability 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. Utilize a logical methodical approach when problem solving developing solutions and
making recommendations. Ability to work independently and prioritize assignments to meet project schedules. Ability to design experiments monitor toxicology studies interpret the results and draw meaningful 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 6-10 years of relevant work experience or PhD with relevant experience during thesis (&/or Post-doc) e.g. in in vitro and in vivo PreClinical pharmacological (preferably sterile injectable/parenteral formulations) and toxicological studies and risk assessment of chemicals drug packaging system.

Preferred:

• DABT or ERT certification
• Previous experience in pharmaceutical or medical device toxicological risk assessment

Skills

Demonstrated competency and experience with toxicological principles and applications. Demonstrated ability in clear and effective communication (written oral) and presentation skills to global stakeholders Fluency in English. Can effectively communicate with internal and external customers. Good computer skills: email good documentation practice and collaboration tools: e.g. Zoom Teams Microsoft Office products etc. Demonstrated ability to work in a matrix environment with multiple stakeholders Demonstrates flexibility and the ability to shift gears between projects comfortably. Proven ability to deliver results by owning & being accountable for budget timeline and product/project deliverables

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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