Ahmedabad, Gujarat
- Experience
- 4-8 Years
- Salary
- Not Disclosed
- Work Location Type
- On-site
- Job Type:
- Full-time
- Shift Type:
- Day shift
Eligibility:Masters
- Skills:
- Analytical method development and validation
- Technology Transfer
Job Description
Summary
Baxter International Inc. is seeking an experienced Research Scientist I to join its Global Pharmaceutical Research & Development (GPRD) Complex Product Development team in Ahmedabad, India.
The selected candidate will be responsible for executing analytical development activities for complex injectable pharmaceutical products, including peptide-based and iron-based formulations. The role involves analytical method development, pre-validation, method validation, technology transfer, stability studies, product characterization, and regulatory submission support.
Responsibilities
- Execute analytical method development, validation, and technology transfer activities.
- Perform analytical testing and characterization of APIs, drug products, stability samples, and development batches.
- Support regulatory submissions by generating analytical data and responding to regulatory queries.
- Prepare and review analytical reports, SOPs, Methods of Analysis (MOAs), and study protocols.
- Investigate OOS, OOT, deviations, and laboratory non-conformances.
- Operate and troubleshoot analytical instruments and support equipment qualification activities.
- Perform complex analytical studies involving peptide and iron colloidal drug products.
- Maintain accurate laboratory records in ELN and ensure ALCOA++ data integrity compliance.
- Support stability studies, vendor qualification, CAPA, and risk assessments.
- Collaborate with cross-functional teams, CMOs, suppliers, and global stakeholders
Qualifications
- Master's Degree with 5–8 years of relevant experience OR PhD with 4–6 years of relevant experience.
- Strong experience in pharmaceutical analytical development.
- Experience with complex injectables, sterile products, or parenteral formulations.
- Hands-on expertise in analytical method development, validation, technology transfer, and stability studies.
- Experience supporting regulatory submissions.
