Role Objective To drive analytical development deliverables for Biologics projects targeting regulated markets. Responsible for independent planning, execution, and review of analytical activities, including method development, qualification, technology transfer, biosimilarity assessment, forced degradation, and protein characterization to support the pipeline of biotherapeutic candidates.

Key Responsibilities

- Experimental Planning &
- Execution: Independently plan and execute analytical experiments, specializing in HPLC, UPLC, and Capillary Electrophoresis (CE) techniques for biotherapeutics.
- Analytical Method Life Cycle: Perform analytical method development, qualification, and technology transfer for biologics products destined for regulated markets.
- Biopharmaceuticals Characterization &
- Biosimilarity: Conduct analytical similarity assessments, forced degradation studies, and characterization activities for biotherapeutic proteins (e.g., monoclonal antibodies and biosimilars).
- Specialized Testing: Perform chromatographic (RP, HIC, IEX, SEC), electrophoretic (cIEF, CZE, CE-SDS), spectrophotometric, and colorimetric assays for biotherapeutics.
- Data Integrity &
- Compliance: Maintain complete data integrity during all analytical analyses, following established laboratory systems and SOPs.
- Documentation &
- Reporting: Prepare, review, and compile high-quality technical reports and data summaries while maintaining target completion dates.
- Troubleshooting: Contribute actively to troubleshooting analytical methods and laboratory instrumentation.

Type of Interaction: Internal Interaction with: Analytical Development Lab peers, cross-functional project team members,



and internal quality/regulatory teams.

Nature of Interaction: Effective communication of analytical data, collaborative project updates, and joint troubleshooting efforts.

Type of Interaction: External

Interaction with: External testing facilities, CROs/CDMOs, and vendor technical support

Nature of Interaction: Technical query resolution, instrument calibration/maintenance coordination, and technology transfer discussions.

Job Requirements

Qualified Experience and Relevant Skills

- 2 to 4 years of hands-on experience in Analytical Development (Biologics/Biosimilars)
- Proven experience working on biotherapeutic proteins such as monoclonal antibodies or candidate biosimilars
- Mandatory experience in method development and qualification.

Skills &

- Technical Expertise

Core Chromatography &

- Electrophoresis: Mandatory hands-on expertise in HPLC and UPLC platforms. Strong working knowledge and practical experience with various chromatography modes (RP, HIC, IEX, SEC) and capillary electrophoresis techniques (cIEF, CZE, CE-SDS).

Specialized Characterization (Added Advantage): Hands-on experience in N-Glycan analysis, Sialic acid analysis, Peptide mapping, and amino acid analysis.

Higher-Order Structure (HOS) Analysis (Advantageous): Familiarity with techniques like DSC, CD, Fluorescence, FTIR, etc.

Regulatory &

- Quality Framework: Strong understanding of Critical Quality Attributes (CQA), Quality Target Product Profile (QTPP), Analytical similarity, forced degradation studies, and specifications setting.

Academic Qualifications

- Educational Qualification: M.Sc / M.Tech / M.Pharm / Ph.D. in Biochemistry, Biotechnology, Analytical Chemistry, or related Life Sciences disciplines.

📌 Research Analyst - BRL - Analytical lab (Maharashtra)
🏢 USV Private
📍 Maharashtra