Manager - Analytical Development (Biosimilar)

BDR Pharmaceuticals; Panchmahal District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

BDR Pharmaceuticals is seeking an experienced Analytical Development professional to lead biosimilar analytics, focusing on monoclonal antibodies and related proteins. The role involves developing and transferring methods for characterization and QC, establishing QTPP-based strategies, and generating data to demonstrate similarity and consistency with reference products.

The candidate should have 6–10 years of biosimilars experience, hands-on work with orthogonal analytical techniques, and

Qualifications

• 6–10 years of relevant industry experience in analytical development of biologics/biosimilars.
• Hands-on experience in analytical characterization of monoclonal antibodies.
• Experience leading analytical development projects for biosimilars.
• Strong understanding of analytical similarity and comparability requirements.
• Hands-on experience with multiple orthogonal analytical techniques.
• Experience with analytical method development, qualification/validation.
• Experience with stability and forced degradation studies.
• Mandatory exposure to regulatory submissions for biosimilars/biologics.
• Ability to independently interpret complex analytical datasets and prepare robust conclusions.

Responsibilities

• Lead analytical development activities for biosimilar products, focusing on monoclonal antibodies and therapeutic proteins.
• Develop, optimize, transfer analytical methods for characterization and quality control.
• Establish strategies based on QTPP, CQAs and reference product.
• Design and execute studies to compare biosimilars with reference products.
• Generate data demonstrating similarity, comparability and consistency.
• Develop analytical control strategies and support product/process development teams.
• Coordinate method transfer and regulatory documentation.

Skills

Analytical development

Biosimilars

Monoclonal antibody characterization

Analytical techniques

Regulatory submissions

Data interpretation

Tools

HPLC/UHPLC

LC-MS/HRMS

SEC/HPLC

IEX/HIC RP-HPLC

Capillary electrophoresis

cIEF

SDS-PAGE

Glycan analysis

Job description

Key Responsibilities

1. Analytical Development of Biosimilars

• Lead analytical development activities for biosimilar products, with primary focus on monoclonal antibodies and other therapeutic proteins.
• Develop, optimize, qualify and transfer analytical methods for characterization and quality control of biosimilar products.
• Establish analytical strategies based on the quality target product profile (QTPP), critical quality attributes (CQAs) and reference product characteristics.
• Design and execute analytical characterization studies comparing the biosimilar with the reference product.
• Generate scientifically sound analytical data to demonstrate similarity, comparability and consistency.
• Develop analytical control strategies for biosimilar products and support product/process development teams.

2. Monoclonal Antibody Characterization

Strong understanding of the critical characteristics and quality attributes of monoclonal antibodies, including:

• Primary structure and amino acid sequence
• Molecular weight and intact mass
• Higher-order structure
• Protein purity
• Aggregation and fragmentation
• Charge variants
• Glycosylation/glycan profile
• Disulfide bonds
• Oxidation, deamidation and other post‑translational modifications
• Host cell proteins and residual DNA
• Product‑related impurities
• Process‑related impurities
• Binding activity
• Biological activity/potency
• Thermal and conformational stability
• Forced degradation and degradation pathways

The candidate should understand how these attributes can influence the safety, efficacy, stability and biological activity of monoclonal antibody products.

3. Analytical Techniques

Hands‑on experience and strong working knowledge of analytical characterization techniques such as:

• HPLC/UHPLC
• SEC‑HPLC/UHPLC for aggregation and fragments
• Ion‑exchange chromatography (IEX) for charge variants
• Hydrophobic interaction chromatography (HIC)
• Reverse‑phase chromatography (RP‑HPLC)
• LC‑MS / HRMS
• Intact mass analysis
• Peptide mapping
• Glycan/glycosylation analysis
• Capillary electrophoresis, including CE‑SDS and cIEF
• SDS‑PAGE
• UV/Vis spectroscopy
• Circular dichroism and other spectroscopic techniques
• ELISA and ligand‑binding assays
• SPR/BLI or equivalent binding technologies
• Cell‑based potency/bioassays
• Thermal stability and conformational characterization
• Residual DNA and host‑cell protein analysis
• Other orthogonal analytical technologies relevant to biologics characterization

4. Analytical Comparability & Biosimilarity Assessment

• Develop comprehensive analytical comparability strategies for biosimilar versus reference products.
• Plan and execute head‑to‑head characterisation studies.
• Identify and assess critical quality attributes and potential quality differences.
• Evaluate analytical variability and establish scientifically justified acceptance criteria.
• Apply orthogonal analytical techniques to provide a comprehensive characterization package.
• Support risk assessment, statistical evaluation and interpretation of analytical data.
• Identify potential product differences and lead investigations to understand their impact.
• Prepare technical conclusions supporting biosimilarity.

5. Equipment & Laboratory Infrastructure

The candidate should have practical knowledge of equipment and infrastructure required for analytical development and characterization of biosimilars, including:

• HPLC/UHPLC systems
• SEC, IEX, HIC and RP‑HPLC systems
• LC‑MS/HRMS systems
• Capillary electrophoresis systems
• CE‑SDS and cIEF platforms
• Peptide mapping and mass spectrometry platforms
• Glycan analysis systems
• SPR/BLI instruments
• ELISA platforms
• Cell‑based bioassay infrastructure
• UV/Vis spectrophotometers
• Circular dichroism and other biophysical characterization instruments
• Differential scanning calorimetry and/or equivalent thermal characterization systems
• Stability chambers
• Sample preparation and protein purification systems
• Appropriate data acquisition, processing and analytical software

The incumbent should be capable of defining analytical infrastructure requirements, evaluating equipment capabilities, supporting instrument selection and establishing appropriate analytical laboratories for biosimilar development.

6. Method Development, Qualification & Validation

• Develop stability‑indicating and product‑specific analytical methods.
• Optimize analytical methods for specificity, accuracy, precision, linearity, range, robustness and sensitivity, as applicable.
• Prepare analytical development protocols, reports and method transfer documents.
• Support analytical method qualification/validation activities.
• Establish appropriate system suitability criteria and analytical procedures.
• Support transfer of analytical methods to QC and/or other development sites.
• Investigate analytical deviations, atypical results and out‑of‑trend results in collaboration with Quality/QC teams.

7. Stability & Degradation Studies

• Design and monitor stability programs for biosimilar products.
• Develop appropriate forced degradation studies to understand degradation pathways.
• Evaluate degradation‑related CQAs, including aggregation, fragmentation, oxidation, deamidation and charge heterogeneity.
• Establish scientifically justified stability‑indicating analytical methods.
• Interpret stability data and provide technical inputs for shelf‑life assessment.

8. Regulatory Submission Mandatory

Previous exposure to regulatory submissions for biosimilars/biologics is mandatory.

• Provide analytical development and characterization inputs for regulatory dossiers.
• Prepare/review analytical sections of CMC documentation.
• Generate and review analytical characterization and comparability reports.
• Support regulatory responses, deficiency responses and agency queries.
• Provide scientific justification for analytical methods, specifications, comparability assessments and observed product differences.
• Work closely with Regulatory Affairs, Quality, Process Development and other cross‑functional teams during submission activities.
• Knowledge of global regulatory expectations for biosimilars, including US FDA, EMA and other major regulatory agencies, will be an advantage.

Mandatory Technical & Industry Experience

The candidate should have:

• 6–10 years of relevant industry experience in analytical development of biologics/biosimilars.
• Demonstrated hands‑on experience in analytical characterization of monoclonal antibodies.
• Previous involvement in the successful development of multiple biosimilar products.
• Strong understanding of analytical similarity and comparability requirements.
• Hands‑on experience with multiple orthogonal analytical techniques.
• Experience in analytical method development, optimization and qualification/validation.
• Experience with stability and forced degradation studies.
• Mandatory exposure to regulatory submissions for biosimilars/biologics.
• Ability to independently interpret complex analytical datasets and prepare scientifically robust conclusions.

Experience in leading analytical development projects and/or a technical team