Principal Scientist – Forced Degradation
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time
Experience: MS (8–10+ years) or PhD (4–6+ years)
Qualification: Biochemistry / Analytical Chemistry / Biotechnology or related field
Salary Range: Not Specified
Job Overview
Alvotech is seeking a Principal Scientist – Forced Degradation to lead analytical strategy and scientific evaluation for biosimilar development programs.
This role focuses on critical quality attribute (CQA) assessments, forced degradation studies, analytical similarity, and comparability. The candidate will play a key role in interpreting complex analytical datasets and generating high-quality scientific documentation for regulatory submissions.
This is a highly technical and strategic position suited for experienced scientists in biologics and analytical characterization.
Key Responsibilities
CQA Assessment & Analytical Strategy
Perform Critical Quality Attribute (CQA) assessments for biosimilar programs.
Define analytical strategies aligned with biosimilarity and regulatory expectations.
Support risk-based approaches and scientific justification of CQAs.
Study Design & Protocol Development
Author and review study protocols with clear scientific rationale.
Define acceptance criteria and CQA-based strategies.
Ensure alignment with regulatory and scientific standards.
Analytical Data Interpretation
Interpret complex analytical datasets across multiple techniques.
Provide concise, scientifically robust summaries and conclusions.
Ensure data integrity and alignment with study objectives.
Scientific Writing & Regulatory Support
Prepare and review scientific reports for forced degradation and comparability studies.
Contribute to regulatory submissions and technical documentation.
Develop analytical similarity (AS) and comparability reports.
Cross-Functional Collaboration
Collaborate with analytical development, process development, and regulatory teams.
Support biosimilar development strategy across functions.
Ensure alignment between analytical results and regulatory expectations.
Required Qualifications
MS with 8–10+ years or PhD with 4–6+ years of relevant experience.
Strong experience in biosimilar analytical characterization.
Expertise in forced degradation and comparability studies.
Excellent scientific writing and communication skills.
Strong analytical thinking and data interpretation capabilities.
Preferred Technical Skills
Hands-on or oversight experience with advanced analytical techniques:
HPLC / UPLC chromatography
LC-MS (Liquid Chromatography–Mass Spectrometry)
CE-SDS, cIEF
Glycan analysis
AUC (Analytical Ultracentrifugation), DLS
FTIR, DSC, Circular Dichroism (CD)
Knowledge of degradation pathways including oxidation, deamidation, aggregation, and fragmentation.
Experience with CQA assessment, risk ranking, and biosimilarity principles.
Ability to interpret multi-attribute datasets and provide scientific justification.
Experience preparing regulatory-ready analytical similarity and comparability documentation.
Key Competencies
Analytical strategy and biosimilarity assessment
Forced degradation and stability studies
Advanced analytical characterization techniques
Scientific writing and regulatory documentation
Cross-functional collaboration
Data interpretation and problem-solving
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused on developing and manufacturing high-quality biosimilar medicines.
With a strong emphasis on innovation, accessibility, and global health impact, the company aims to expand access to affordable biologics while fostering a collaborative and inclusive work environment rooted in integrity and scientific excellence.
If you want, I can now compare all these roles (PV, Medical Writing, Data Management, Scientist) and tell you which one best fits your experience or career goals.
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