Senior Scientist, Analytical R&D
Company
Alvotech
Job Details
Job Title: Senior Scientist, Analytical R&D
Job Requisition ID: JR100292
Employment Type: Full-Time
Work Mode: Partially Remote
Location: Bangalore Office, India
Posted: 27 Days Ago
Position Summary
The Senior Scientist, Analytical R&D will support biosimilar development programs through Critical Quality Attribute (CQA) assessments, analytical strategy development, data interpretation, protocol authoring, and scientific reporting. The role plays a key part in Analytical Similarity (AS) and Comparability studies, ensuring scientifically robust and regulatory-compliant analytical evaluations.
Key Responsibilities
CQA Assessment & Analytical Strategy
Conduct Critical Quality Attribute (CQA) assessments for biosimilar programs.
Develop and implement CQA-based analytical strategies.
Apply risk-based approaches to biosimilarity assessments and comparability evaluations.
Define acceptance criteria and scientific rationale for analytical studies.
Protocol & Report Authoring
Author and review study protocols with clear scientific objectives and methodology.
Prepare and review scientific reports supporting:
Analytical Similarity (AS) studies
Comparability assessments
Biosimilar development programs
Contribute technical content for regulatory submissions and responses.
Data Analysis & Interpretation
Interpret complex analytical datasets and generate scientifically sound conclusions.
Review analytical results for accuracy, consistency, and alignment with study objectives.
Provide clear scientific justification for observed analytical differences or similarities.
Cross-Functional Collaboration
Collaborate with:
Analytical Development teams
Process Development teams
Regulatory Affairs teams
Support scientific discussions and strategic decision-making for biosimilar programs.
Required Qualifications
Education
Master’s Degree (MS) in:
Biochemistry
Analytical Chemistry
Biotechnology
Related Scientific Discipline
Experience Required: 6–10+ years
OR
PhD in:
Biochemistry
Analytical Chemistry
Biotechnology
Related Scientific Discipline
Experience Required: 2–4+ years
Required Experience
Biosimilar Development
Experience in biosimilar analytical characterization.
Strong background in analytical similarity assessments.
Experience in scientific report writing and documentation.
Regulatory & Scientific Knowledge
Understanding of:
ICH Comparability Guidelines
Analytical Similarity principles
Forced Degradation studies
Biosimilarity assessment methodologies
Technical Competencies
Strong scientific writing and technical communication skills.
Ability to critically review analytical data and reports.
Experience supporting regulatory documentation and submissions.
Preferred Technical Skills
Analytical Characterization Techniques
Hands-on experience or technical oversight in one or more of the following:
HPLC / UPLC-based analytical chromatography techniques
CE-SDS (Capillary Electrophoresis-Sodium Dodecyl Sulfate)
cIEF (Capillary Isoelectric Focusing)
LC-MS (Liquid Chromatography-Mass Spectrometry)
Glycan Analysis
AUC (Analytical Ultracentrifugation)
DLS (Dynamic Light Scattering)
FTIR (Fourier Transform Infrared Spectroscopy)
DSC (Differential Scanning Calorimetry)
CD (Circular Dichroism)
Protein Characterization & Stability
Knowledge of degradation pathway analysis, including:
Oxidation
Deamidation
Aggregation
Fragmentation
Biosimilarity & Risk Assessment
CQA assessment and risk ranking methodologies.
Biosimilarity evaluation frameworks.
Comparability study design and interpretation.
Data Interpretation
Ability to analyze complex multi-attribute datasets.
Generate scientifically defensible conclusions and justifications.
Experience preparing:
Analytical Similarity (AS) Reports
Comparability Assessments
Regulatory-ready technical documentation
Key Competencies
Strong analytical and scientific reasoning skills.
Excellent technical writing and documentation abilities.
Attention to detail and data quality.
Cross-functional collaboration and stakeholder management.
Problem-solving and decision-making capabilities.
Ability to communicate complex scientific findings clearly and effectively.
Ideal Candidate Profile
The ideal candidate will have substantial experience in biosimilar analytical characterization, CQA assessment, and comparability studies, along with strong expertise in protein characterization techniques and regulatory documentation. This role is particularly suited for professionals from the biologics, biosimilars, biopharmaceutical, or analytical development sectors.
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Remote, India | Siliguri |Illinois :
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