Analytical & CMC Lead Biosimilars

The Analytical & CMC Lead drives the strategy and execution of physicochemical, structural, and functional characterization for monoclonal antibodies (mAbs) and other recombinant proteins. This role is directly responsible for in house and outsourced methods, their development, qualification, tech transfer and Validation. Additionally this role bridges R&D, manufacturing, and regulatory affairs to establish comprehensive data packages required for global health authority filings. The Person should have demonstrated technical competency, documentation skills, deep understanding of guidelines. Able to work under challenging environments, meet timelines and work towards cost effective strategies. Preferably, 10 years of experience with PhD or 15 years of experience with Masters.

Key Responsibilities

Analytical Similarity & Characterization: Design and oversee comprehensive analytical similarity programs comparing the biosimilar candidate against the reference/innovator product across purity, potency, charge variants, and higher-order structures.

Method Lifecycle Management: Lead the development, optimization, qualification, validation, and transfer of analytical methods (HPLC/UPLC, SEC, IEX, RP-HPLC, cIEF/icIEF, CE-SDS, LC-MS, and cell-based potency assays).

Quality by Design (QbD) & CQAs: Identify and rank Critical Quality Attributes (CQAs), define process control strategies, and analyze forced degradation and stability study data.

CMO/CRO & Matrix Leadership: Manage external testing laboratories, CMO/CDMO analytical deliverables, and cross-functional project teams.

Regulatory Submissions: Author and review analytical sections of regulatory dossiers, respond to health authority queries, and support GMP audits.

Troubleshooting: Investigate analytical deviations, out-of-specification (OOS) results, and root-cause analyses with corrective and preventive actions (CAPA).

Technical Expertise:

Advanced chromatographic and electrophoretic methods (HPLC, UPLC, SEC, IEX, HIC, cIEF, CE-SDS).

Mass spectrometry (LC-MS) for primary structure and post-translational modification (PTM) analysis.

Biophysical characterization and cell-based potency/ELISA assays.

Regulatory Knowledge: Deep familiarity with ICH, FDA, and EMA guidelines for biosimilars and quality risk management.