Research Associate I – R&D Complex Product Development
Company: Baxter
Department: Research & Development – Complex Product Development
Location: Ahmedabad, India
Function: Research & Development (R&D)
Position Summary
The Research Associate I is responsible for executing advanced analytical characterization studies for complex injectable products. The role supports product development, regulatory submissions, method development, outsourced research management, and technical problem-solving while ensuring compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and global regulatory standards.
Key Responsibilities
Advanced Analytical Characterization
Perform characterization studies for complex injectable products, including:
Iron formulations
Proteins and peptides
Oligonucleotides
Carbohydrates
Biomolecular APIs
Related impurities
Analyze products in various dosage forms including:
Lyophilized products
Liquid formulations
Emulsions
Other injectable systems
Generate data for regulatory submissions following GLP requirements.
Method Development & Validation
Develop, optimize, and qualify analytical methods.
Conduct:
Method Development
Method Qualification
Sameness Studies
Routine Analytical Testing
Prepare method development, validation, and verification reports.
Ensure methods meet regulatory and scientific standards.
Technical Subject Matter Expertise
Provide scientific expertise to support product development programs.
Collaborate with formulation scientists and cross-functional teams.
Support resolution of technical and analytical challenges.
Contribute scientific insights for complex product development activities.
External Study Management
Manage outsourced studies conducted at:
Contract Research Organizations (CROs)
Academic Institutions
External Testing Facilities
Coordinate:
Study design
Execution
Data review
Analysis
Report preparation
Travel to external facilities when required.
Laboratory Operations
Conduct testing according to approved SOPs and pharmacopoeial requirements.
Follow ALCOA++ principles for data integrity.
Record and review data in Electronic Laboratory Notebooks (ELN).
Ensure timely completion of testing and documentation.
Monitor reagent and chemical shelf life before use.
Equipment Management
Operate laboratory instruments according to approved procedures.
Perform:
Calibration
Preventive Maintenance
Troubleshooting
Breakdown Maintenance
Report maintenance outcomes and equipment issues to management.
Quality & Compliance
Adhere to:
Good Laboratory Practices (GLP)
Good Documentation Practices (GDP)
ICH Guidelines
Pharmacopoeial Requirements
Investigate deviations and abnormal observations.
Perform trend analysis before reporting results.
Maintain accurate laboratory records and documentation.
Procurement & Resource Planning
Identify laboratory resource requirements.
Support procurement activities and supplier interactions.
Review quotations and coordinate purchasing activities.
Verify incoming materials against specifications.
Training & Documentation
Complete required training programs and quality matrix targets.
Develop and update Standard Operating Procedures (SOPs).
Maintain training and compliance records.
Support documentation management and reporting activities.
Administrative Responsibilities
Project & Workflow Management
Execute tasks assigned by the Sub-department Manager.
Track progress of assigned projects and activities.
Maintain online documentation and analytical records.
Prepare data for Management Information System (MIS) reporting.
Stakeholder Coordination
Coordinate with:
Internal project teams
Suppliers
External partners
Service providers
Support smooth project execution and communication.
Communication Responsibilities
Issue Escalation
Report deviations, failures, non-compliance, and abnormal findings promptly.
Communicate project-related challenges and risks to management.
Support implementation of corrective and preventive actions.
Status Reporting
Provide regular updates on daily activities and project progress.
Ensure timely communication of critical issues affecting project timelines.
Minimum Requirements
Education
Option 1
Master's Degree in:
Pharmacy
Pharmaceutical Sciences
Related Scientific Discipline
6–10 years of relevant industry experience.
Option 2
PhD in:
Biophysics
Biochemistry
Related Scientific Discipline
0–5 years of relevant experience.
Required Technical Expertise
Core Analytical Techniques
SEC-UV-MALS (Size Exclusion Chromatography–UV–Multi-Angle Light Scattering)
Light Scattering Technologies
Light Diffraction Techniques
Light Obscuration Methods
Biomolecular Characterization
Complex Product Analysis
Peptides
Proteins
Iron Colloidal Products
Complex Injectable Formulations
Biophysical & Spectroscopic Techniques
Circular Dichroism (CD)
FTIR Spectroscopy
UV Spectroscopy
Fluorescence Spectroscopy
Electron Paramagnetic Resonance (EPR)
Mössbauer Spectroscopy
Particle XRD
Microscopy Techniques
Atomic Force Microscopy (AFM)
Electron Microscopy (EM)
Instrument Experience
NMR Operation and Maintenance
Analytical Instrument Calibration
Instrument Troubleshooting
Preventive Maintenance Programs
Regulatory Knowledge
ICH Guidelines
Pharmacopoeial Standards
GLP & GDP Compliance
Regulatory Submission Requirements
Scientific Research Skills
Literature Reviews
Patent Database Searches
Scientific Publication Analysis
Regulatory Intelligence Monitoring
Desirable Skills
Computational Chemistry
Molecular Modeling
Statistical Data Analysis
Behavioral Competencies
Communication & Collaboration
Strong verbal and written communication skills.
Effective presentation and stakeholder engagement abilities.
Cross-functional collaboration and teamwork.
Professional Attributes
Analytical Thinking
Scientific Problem Solving
Attention to Detail
Positive Attitude
Policy Compliance
Documentation Excellence
Time Management
Ideal Candidate Profile
Strong expertise in advanced analytical characterization of complex injectable products.
Hands-on experience with SEC-UV-MALS and particle characterization techniques.
Familiarity with regulatory requirements for biosimilars, injectables, and complex drug products.
Ability to independently manage studies while collaborating across multidisciplinary teams.
Strong scientific writing, data interpretation, and technical troubleshooting skills.
Career Focus Areas
Complex Injectable Product Development
Analytical Research & Development
Biopharmaceutical Characterization
Regulatory Science
Method Development & Validation
Advanced Spectroscopy & Chromatography
Pharmaceutical Product Development
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