Head Analytical Development - Large Molecule

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:

1. 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.

2. 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.

3. 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.

4. 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.