Research Associate I – R&D Complex Product Development
Company: Baxter
Location: Ahmedabad, India
Department: Research & Development (Complex Product Development)
Position Summary
The Research Associate I will be responsible for executing advanced characterization studies for complex injectable products, including method development, method qualification, sameness studies, and routine analytical testing. The role supports Baxter's global R&D initiatives and provides analytical support to Baxter manufacturing and contract manufacturing sites.
Key Responsibilities
1. Analytical & Research Activities
Advanced Characterization Studies
Perform characterization of complex injectable products, including:
Iron formulations
Proteins and peptides
Oligonucleotides
Carbohydrates
Other biomolecular APIs and related impurities
Analyze various dosage forms:
Lyophilized products
Liquid formulations
Emulsions
Other complex formulations
Ensure compliance with GLP requirements and support regulatory submissions.
Method Development & Validation
Develop, qualify, verify, and optimize analytical methods.
Prepare method development and verification reports.
Conduct routine analytical testing and data interpretation.
Subject Matter Expertise
Provide technical expertise to cross-functional teams.
Support formulation development activities.
Assist in resolving scientific and technical challenges during product development.
2. External Study Management
Coordinate outsourced studies with:
CROs
Academic institutions
External laboratories
Manage:
Study design
Execution
Data analysis
Report preparation
Travel to external facilities when required.
3. Laboratory Operations
Instrument Management
Operate analytical instruments as per SOPs.
Perform:
Calibration
Preventive maintenance
Breakdown maintenance
Report maintenance outcomes to management.
Laboratory Compliance
Follow:
Good Laboratory Practices (GLP)
Good Documentation Practices (GDP)
ALCOA++ principles
Record data accurately in ELN systems.
Verify reagent and chemical shelf-life before use.
Documentation
Maintain:
Laboratory notebooks
Analytical records
SOPs
Study reports
Ensure timely completion and review of documentation.
4. Quality & Compliance
Investigate deviations, abnormalities, and non-conformances.
Analyze trends before reporting results.
Follow pharmacopoeial requirements and ICH guidelines.
Ensure regulatory compliance throughout development activities.
Complete all assigned training requirements as per quality matrix targets.
5. Procurement & Resource Planning
Support procurement activities by:
Reviewing quotations
Interacting with suppliers
Ensuring timely purchase of materials and services
Monitor resource requirements for ongoing studies.
Verify received materials against specifications.
6. Reporting & Communication
Daily Reporting
Maintain daily activity status.
Report progress and issues to the Sub-Department Manager.
Management Communication
Escalate:
Analytical failures
Deviations
Non-compliance observations
Project-related challenges
Assist in implementing corrective actions.
Administrative Support
Coordinate with customers, suppliers, and internal stakeholders.
Compile Management Information System (MIS) data.
Maintain legible and accurate records.
Qualifications
Education
Option 1
Master's Degree in:
Pharmacy
Pharmaceutical Sciences
Equivalent discipline
Experience: 6–10 years of relevant experience
Option 2
PhD in:
Biophysics
Biochemistry
Equivalent discipline
Experience: 0–5 years of relevant experience
Required Technical Skills
Mandatory Expertise
SEC-UV-MALS
Light scattering techniques
Light diffraction techniques
Light obscuration methods
Liquid chromatography
Analysis of:
Peptides
Iron colloidal products
Regulatory submission support
Preferred Skills
Computational chemistry
Molecular modeling
Statistical analysis methods
Scientific Knowledge
Biophysical and Spectroscopic Techniques
Circular Dichroism (CD)
FTIR
UV Spectroscopy
EPR
Mössbauer Spectroscopy
Fluorescence Spectroscopy
Structural Characterization Tools
Particle XRD
AFM
Electron Microscopy (EM)
Additional Expertise
Literature and patent database searching
PubMed and scientific repository usage
Regulatory science updates and webinars
Pharmacopoeia and ICH guideline implementation
NMR operation, calibration, and maintenance
Analytical troubleshooting
GLP and GDP compliance
Key Behavioral Competencies
Strong communication skills
Effective presentation skills
Analytical thinking
Cross-functional collaboration
Positive attitude
Policy and compliance orientation
Documentation excellence
Lateral coordination and teamwork
Success Traits at Baxter
Courage
Action Orientation
Collaboration
Innovation Mindset
Ability to Manage Ambiguity
Results-Driven Approach
Employee Benefits
Support for parents
Continuing education and professional development
Health and wellness benefits
Paid time off
Two paid volunteer days per year
Equal Opportunity Statement
Baxter is an Equal Opportunity Employer and considers all qualified applicants without discrimination based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, veteran status, disability, or any other protected characteristic.
Reasonable Accommodation
Baxter provides reasonable accommodations to individuals with disabilities during the application and interview process.
Recruitment Fraud Awareness
Candidates should remain vigilant against employment scams involving individuals falsely claiming to represent Baxter. Applicants are encouraged to review Baxter's Recruitment Fraud Notice for guidance and protection.
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