Head Analytical Development - Large Molecule

Syngene International; Bengaluru; Sur place; INR 3 500 000 - 6 500 000; Plein temps

Résumé du poste

Syngene International in Bangalore seeks an accomplished Head of Analytical Development (Biopharmaceuticals) to lead all analytical development and characterization activities, driving strategic leadership and operational excellence for biologics. The role interfaces with clients, regulators, and cross-functional teams to ensure robust analytical packages across modalities.

The position requires deep expertise in analytical sciences, CRDMO operations, and a proven track record in leading large

Qualifications

• PhD or MSc/ME in Analytical Chemistry, Biochemistry, Biotechnology, or related field.
• 12-20 years of experience in analytical development of biopharmaceuticals, preferably in a CDMO/CMO/CRO environment.
• Demonstrated leadership experience managing analytical teams (30+ members).
• Proven track record in developing, validating, and transferring analytical methods for biologics.
• In-depth knowledge of global regulatory expectations and analytical control strategies.
• Strong client-facing communication and scientific presentation skills.
• Experience managing multiple client projects and timelines in a dynamic CRDMO setup.

Responsabilités

• Lead analytical development strategy and build capabilities for diverse biologics.
• Serve as analytical technical lead for client projects with timely, transparent delivery.
• Oversee method development, validation, and transfer to QC or manufacturing sites.
• Ensure regulatory compliance and audit readiness of analytical labs.

Connaissances

Leadership

Project management

Client-facing communication

Analytical development

Formation

PhD in Analytical Chemistry/Biochemistry/Biotech

MTech/MSc in Analytical Chemistry/Biochemistry/Biotech

Description du poste

Date: 11 Oct 2026

Location: Bangalore, KA, IN, 560099

Division: Development Services

Head - Analytical Development (Biopharmaceuticals, CRDMO)

Position Summary

The Analytical Head - Biopharmaceuticals will lead all analytical development and characterization activities supporting client projects. The role requires strategic scientific leadership, operational excellence, and client-focused delivery to ensure robust analytical packages for all modalities of Biologics in compliance with global regulatory standards.

The position demands strong expertise in analytical sciences, an understanding of CRDMO operations, and the ability to interface effectively with clients, regulatory bodies, and cross-functional internal teams.

Key Responsibilities

• Leadership and Strategy: Define and execute analytical development strategy aligned with client and organizational goals. Lead a multidisciplinary team of scientists in method development, qualification and routine testing for biologics. Build analytical capabilities to support diverse molecule types - monoclonal antibodies, recombinant proteins, fusion proteins, ADCs, and therapeutic proteins.
• Project and Client Management: Serve as the analytical technical lead for client projects, ensuring scientific rigor, timely delivery, and transparency. Participate in client meetings, technical reviews, and due diligence activities to represent analytical expertise. Prepare and present analytical development plans, data summaries, and regulatory packages to clients and partners. Ensure robust project execution aligned with CRDMO project management principles - on time, on quality, and within scope.
• Technical Excellence: Oversee method development, optimization, and transfer to QC or manufacturing sites. Ensure data integrity, technical accuracy, and traceability across all analytical operations. Support process development, formulation, and stability programs through analytical insights.
• Regulatory and Compliance: Ensure adherence to global regulatory guidelines (ICH, USFDA, EMA, WHO, CDSCO etc). Provide analytical input for CMC documentation. Support regulatory inspections and client audits; ensure audit readiness of analytical labs.

Qualifications And Experience

• Ph.D. or M.Tech / M.Sc. in Analytical Chemistry, Biochemistry, Biotechnology, or related field.
• 12-20 years of experience in analytical development of biopharmaceuticals, preferably in a CDMO / CMO / CRO environment.
• Demonstrated leadership experience managing analytical teams (30 members or more).
• Proven track record in developing, validating, and transferring analytical methods for biologics.
• In-depth knowledge of global regulatory expectations and analytical control strategies.
• Strong client-facing communication and scientific presentation skills.
• Experience managing multiple client projects and timelines in a dynamic CRDMO setup.