Research Associate I, R&D Complex Product Development

Baxter

0-5 years

Not Disclosed

Ahmedabad, India

Openings: 10 June 9, 2026

Job Description

Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Apache Spark, Artificial Intelligence (AI), Big Data, Data Governance, Data Literacy, Data Management, Data Quality, Data Science, Data Strategies, Data Visualization, Machine Learning (ML), Master Da, Auditing, Audit Management, Audits Compliance, Communication, Continued Learning, Decision Making, Gmp Procedures, Inspection Readiness, Managing Ambiguity, Organizing, People Management and Leadershi, Bachelor’s Degree (BS) or Master’s Degree (MS) in: Life Sciences Pharmacy Biotechnology Biomedical Sciences Chemistry Regulatory Affairs Or related scientific disciplines, Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Causality Assessment, Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences, Clinical Research, Clinical Trials, Curious Mindset, Databases, Drug Development, Job Description, Lifesciences, Medical Communication, Medical Information, Medical Writing, Military Intelligence, Pat, Clinical SAS Programming, Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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Research Associate I, R&D Complex Product Development

Job Description

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