job title: Research associate 2(vantive)

Essential Duties and Responsibilities:

• Assist or work independently in designing, planning, monitor various GLP toxicity studies, biocompatibility studies, and qualification of impurities with some supervisions from direct manager and senior members of the organization.

• Assist or work independently as an author for toxicological risk assessment reports on leachables, extractables, residual solvents and excipients and review or concur toxicology assessment reports as subject matter expert (SME) in accordance with ICH and ISO10993-17.

• Work independently on hazard evaluation of chemicals used in manufacturing and issuing safety data sheet (SDS).

• Participate as preclinical/toxicology representative and contribute in core technical team meetings as SME and provide inputs and lead task to be executed for completion of projects with effective collaboration and deliverables.

• 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. Utilize in silico tools to assess toxicological endpoints.

Qualifications

• The position requires relevant technical knowledge in toxicology and biocompatibility testing. Demonstrated ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH Q3 guidelines, 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 Life Sciences/Veterinary/Biotechnology/Pharmacy (or relevant) with 4-6 years of relevant work experience, or PhD with relevant experience during thesis (&/or Post-doc) e.g., in in vitro and in vivo pharmacological (preferably sterile injectable/parenteral formulations) and toxicological studies and risk assessment of chemicals, biocompatibility testing of medical devices, drug packaging system.

Skills:

• 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.

• Solid 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.