ASSOCIATE SCIENTIST II, R&D, COMPLEX PRODUCT DEVELOPMENT
Company: Baxter
Location: India
Department: Global Product Research & Development (GPRD) – Complex Product Development
Employment Type: Full Time
JOB OVERVIEW
The Associate Scientist II will be responsible for planning, executing, analyzing, and reviewing analytical development activities for complex injectable products. The role involves analytical method development, validation, technology transfer, stability studies, regulatory support, and compliance with GxP requirements. The position also provides analytical support to Baxter Global and contract manufacturing sites.
KEY RESPONSIBILITIES
• Analytical Method Development & Validation
Plan and execute analytical method development activities.
Perform pre-validation and validation studies.
Conduct analytical technology transfer activities.
Support regulatory submissions for complex injectable products such as peptides and iron formulations.
Assist in responding to regulatory queries related to complex products.
• Sample Analysis & Stability Studies
Analyze API, development, validation, stability, bulk hold, RLD, and PDR samples.
Perform testing according to approved analytical methods.
Execute stability studies and monitor stability programs.
Review stability chamber qualification documents and data logger reports.
• Regulatory & Compliance Support
Ensure compliance with GxP, GDP, ALCOA++, and pharmacopoeial requirements.
Prepare and review analytical reports, SOPs, and methods of analysis.
Support regulatory documentation and submission activities.
Review Drug Master Files (DMFs) from API vendors.
Manage vendor approval processes for APIs and excipients.
• Laboratory Operations
Maintain accurate documentation in ELN systems.
Verify reference standards, chemicals, and reagents before analysis.
Ensure proper calibration and qualification of laboratory instruments.
Support installation and qualification of new analytical equipment.
Manage preventive maintenance and breakdown maintenance activities.
• Quality Management System (QMS)
Investigate OOS, OOT, deviations, non-compliance, and abnormal observations.
Perform risk assessments and implement corrective actions.
Support QMS activities through systems such as TrackWise and TCU.
Maintain compliance with internal quality procedures.
• Project & Resource Management
Track project timelines and analytical activities.
Ensure completion of assigned studies within agreed timelines.
Identify resource requirements and coordinate procurement.
Liaise with suppliers, customers, and internal stakeholders.
Monitor project progress and communicate updates to management.
• Documentation & Reporting
Prepare and review analytical reports and technical documents.
Maintain complete and accurate laboratory records.
Ensure timely closure of documentation activities.
Generate reports for management information systems.
REQUIRED QUALIFICATIONS
Master’s Degree in Science (M.Sc.)
EXPERIENCE
8–12 Years of Experience
Experience in analytical development within pharmaceutical R&D.
Strong exposure to complex injectable products.
Experience in analytical method development, validation, and technology transfer.
Familiarity with regulatory submission requirements.
Uttar Pradesh :
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