Senior Scientist, Analytical R&D

Position Summary
The Senior Scientist is responsible for CQA assessments, defining analytical strategies, interpreting data, writing protocols and preparing scientific reports to support Analytical Similarity, and Comparability studies for biosimilar programs.

Key Responsibilities

• CQA assessment for biosimilar programs.

• Author or review the study protocols with clear scientific rationale, acceptance criteria, and CQA‑based strategy.

• Interpret analytical data and provide concise, scientifically sound summaries.

• Author or review study reports and contribute technical content to regulatory submissions.

• Review analytical results for accuracy and alignment with study objectives.

• Collaborate closely with analytical development, process development, and regulatory teams.

Qualifications

• MS (6–10+ yrs) or PhD (2–4+ yrs) in Biochemistry, Analytical Chemistry, Biotechnology, or related field.

• Experience with biosimilar analytical characterization and scientific report writing.

• Strong understanding of forced degradation, analytical similarity, and ICH comparability principles.

• Excellent scientific writing, data review, and communication skills.

Preferred Technical Skills

• Hands‑on or oversight experience with key characterization methods (e.g., HPLC/UPLC based Analytical chromatography techniques, CE‑SDS, cIEF, LC‑MS, glycan analysis, AUC, DLS, FTIR, DSC, CD).

• Familiarity with degradation pathway analysis (oxidation, deamidation, aggregation, fragmentation).

• Working knowledge of CQA assessment, risk ranking, and biosimilarity principles.

• Ability to interpret complex multi‑attribute datasets and provide clear scientific justification.

• Experience preparing AS reports, comparability assessments, and regulatory‑ready documentation.