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Research Associate Ii

8-14 years
Not Disclosed
10 Oct. 15, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to establish Vantive, a standalone company focused on our Kidney Care segment. With nearly 70 years of experience in acute therapies and both home and in-center dialysis, Vantive is poised to provide exceptional care to those we serve. We believe Vantive will strengthen our leadership in kidney care and offer fulfilling opportunities for those who join our team.

At Vantive, you will be part of a community of dedicated individuals who are focused, courageous, and committed to excellence. Together, we strive to improve patients' lives around the world. Join us as we transform kidney care and support vital organ health.

Note: The proposed sale of Vantive to funds managed by the Carlyle Group is subject to customary regulatory approvals and other closing conditions.

Position Overview

This role involves conducting laboratory testing, including validation, verification, transfer, and stability studies. The ideal candidate will possess strong hands-on technical abilities, a passion for their work, and a commitment to meeting patient needs.

Key Responsibilities

  • Conduct laboratory tests and validation studies independently.
  • Provide technical knowledge and contribute to various projects through testing and designing analytical methods.
  • Collaborate effectively with cross-functional teams (Quality, Regulatory, External partners, etc.).
  • Design experiments, develop and validate analytical methods, and evaluate results.
  • Collect data for the analytical target profile and propose techniques for method development.
  • Write protocols, reports, and procedures with minimal guidance.
  • Evaluate and validate analytical methods, addressing any failed acceptance criteria.
  • Conduct research and development activities to meet project goals, employing new technologies as needed.
  • Perform laboratory testing in compliance with regulatory standards.
  • Develop a thorough understanding of GxP regulations and related guidelines.
  • Execute stability testing according to protocols to support product registration.
  • Manage laboratory investigations (OOS/OOT) and nonconformance/deviation assessments.
  • Enter data and manage samples in LIMS.
  • Adhere to cGxP requirements, ensuring data integrity and compliance.
  • Maintain and troubleshoot laboratory equipment, reporting any malfunctions.
  • Identify risks and propose improvements for existing processes.
  • Collaborate with global teams across various functions (quality, regulatory, operations, etc.).
  • Analyze data, make informed decisions, and present findings in technical meetings.

Qualifications

  • Strong knowledge of regulatory validation and stability guidelines.
  • Proficient in analytical techniques such as HPLC/UPLC, GC, Titration, AAS, etc.
  • Relevant laboratory and technical writing skills, along with computer proficiency.
  • Ability to work effectively in a team and support colleagues.
  • Self-motivated with a strong sense of personal responsibility.
  • Capable of organizing and communicating complex information clearly.
  • Understanding of project timelines and commitment to achieving milestones.
  • Adaptability to shifting priorities and demonstrated critical thinking skills.
  • Familiarity with software such as Empower, Chromeleon, and LIMS.
  • Good learning agility and effective communication skills.
  • Proficient in MS Word, spreadsheets, and related software.

Education: Bachelor’s degree with 8-14 years of experience or a Master’s degree with 5-10 years of experience in a relevant scientific discipline (Analytical Chemistry/Pharmaceutical Chemistry).

Reasonable Accommodations

Baxter is committed to providing reasonable accommodations to individuals with disabilities globally. If you require assistance during the application or interview process due to a medical condition or disability, please let us know your needs along with your contact information.

Recruitment Fraud Notice

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