Associate Scientist II, R&D – Complex Product Development
Company: Baxter
Location: Ahmedabad, Gujarat, India
Job ID: JR - 201290
Employment Type: Full-Time
Department: Global Pharmaceutical Research & Development (GPRD) – Complex Product Development
Job Summary
The Associate Scientist II is responsible for executing, analyzing, reviewing, and documenting analytical development activities for complex injectable products. The role involves analytical method development, validation, technology transfer, stability studies, regulatory support, laboratory compliance, and scientific problem-solving while ensuring adherence to GxP, GDP, ALCOA++, ICH, and pharmacopoeial requirements.
Key Responsibilities
Analytical Method Development & Validation
Execute analytical method development, validation, and technology transfer activities.
Support regulatory submissions for complex injectable products such as:
Peptides
Iron formulations
Sterile injectables
Assist in preparing responses to regulatory queries.
Laboratory Testing & Analysis
Perform analytical testing of:
APIs
Development samples
Validation samples
Stability samples
Bulk hold samples
RLD samples
PDR samples
Ensure testing is conducted according to approved analytical methods and SOPs.
Scientific Problem Solving
Investigate analytical issues and troubleshoot laboratory problems.
Apply scientific knowledge to process improvements and innovation.
Review scientific literature and technical databases to support development activities.
Documentation & Compliance
Prepare and review:
Analytical Reports
SOPs
Methods of Analysis (MOA)
Qualification Documents
Ensure compliance with:
GxP
GDP
ALCOA++
ICH Guidelines
Pharmacopoeial Standards
Maintain accurate records in Electronic Laboratory Notebooks (ELN).
Technology Transfer & Regulatory Support
Support technology transfer activities across internal and external manufacturing sites.
Review API vendor DMFs.
Participate in vendor qualification and approval activities.
Support regulatory documentation and submission requirements.
Equipment & Laboratory Management
Perform and review:
Instrument Calibration
Qualification Activities
Preventive Maintenance
Breakdown Maintenance
Support installation and qualification of laboratory instruments.
Conduct risk assessments and implement corrective actions when required.
Stability Program Management
Review finished product stability programs.
Evaluate stability chamber qualification documents.
Review data logger reports and stability data trends.
Quality & Compliance Management
Investigate:
OOS (Out of Specification)
OOT (Out of Trend)
Deviations
Non-compliance Events
Analytical Failures
Implement corrective and preventive actions (CAPA).
Ensure quality system compliance through TrackWise, TCU, and other QMS platforms.
Project & Administrative Responsibilities
Monitor project timelines and deliverables.
Coordinate with suppliers, internal teams, and stakeholders.
Support procurement and inventory management for laboratory resources.
Provide regular project status updates to management.
Required Qualifications
Education
Master's Degree in:
Pharmaceutical Sciences
Analytical Chemistry
Chemistry
Pharmaceutical Analysis
Life Sciences
Related Scientific Discipline
Experience
8–12 years of pharmaceutical R&D analytical development experience.
Strong experience in:
Complex Injectables
Peptides
Iron-Based Drug Products
Analytical Method Development
Validation
Technology Transfer
Stability Studies
Technical Skills
Analytical Method Development & Validation
Technology Transfer
Complex Injectable Product Development
Stability Testing
Regulatory Documentation
ELN Documentation
OOS/OOT Investigation
Quality Management Systems
Instrument Calibration & Qualification
Pharmacopoeial Testing
ICH Guidelines
GxP & GDP Compliance
Specialized Analytical Expertise
Gel Filtration Chromatography
Particle Size Distribution Analysis
Light Scattering Techniques
Light Diffraction Methods
Assay of Iron Species
Chelation Assays
Reduction Potential & Kinetics Studies
Complex Injectable Characterization
Behavioral Skills
Strong Analytical Thinking
Problem Solving
Scientific Reasoning
Communication Skills
Presentation Skills
Documentation Excellence
Cross-Functional Collaboration
Positive Attitude
Compliance Mindset
Key Contribution
Support development and commercialization of complex injectable products.
Ensure regulatory-compliant analytical data generation.
Drive innovation and operational excellence within pharmaceutical R&D.
Strengthen Baxter's global product development and technology transfer capabilities.
Salary Criteria
Expected Salary: ₹18–30 LPA for candidates with 8–12 years of Analytical R&D experience in complex injectables, peptides, sterile products, or formulation development; professionals with strong method development, technology transfer, and regulatory submission expertise may earn ₹30–40+ LPA depending on technical specialization and leadership responsibilities.
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