Analytical Lead Biologics

Job Title: Analytical Lead – Biologics
Department: Analytical Research & Development
Experience Level: 15+ years

Job Summary:
The Analytical Lead – Biologics will lead the analytical development and characterization of biologics, including monoclonal antibodies, recombinant proteins, and other complex biomolecules. This role requires expertise in analytical techniques, regulatory guidelines, and team leadership to ensure the successful development and commercialization of biologic products.

Key Responsibilities:
Analytical Development & Characterization

• Lead the design and execution of analytical strategies for biologics characterization, stability studies, and release testing.
• Oversee method development and qualification of analytical techniques such as HPLC, UPLC, Mass Spectrometry, ELISA, CE, and other bioassays.
• Ensure robust analytical methods for product comparability, structural integrity, and potency testing.
• Drive the implementation of high-resolution analytical tools for deep characterization of biologics.
• Responsible for QTPP/CQA generation, IRS qualification, RCGM data generation, forced degradation, Bio similarity studies and setting specification

Regulatory & Compliance

• Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, WHO) for biologics analytical development.
• Provide analytical support for regulatory filings, including IND, BLA, and MAA submissions.
• Collaborate with regulatory affairs to address queries from regulatory agencies.

Cross-Functional Collaboration
Work closely with R&D, process development, manufacturing, and quality teams to ensure seamless analytical integration.

• Support technology transfer to commercial manufacturing and external partners.
• Lead external collaborations with CROs, CMOs, and academic institutions for specialized analytical support.

Leadership & Team Management

• Lead and mentor a team of analytical scientists, fostering a culture of innovation and technical excellence.
• Drive continuous improvement initiatives for analytical processes and capabilities.
• Provide technical training and guidance to team members.

Required Qualifications & Skills:

• Ph.D./Master's in Analytical Chemistry, Biochemistry, Biotechnology, or related field.
• 15+ years of experience in analytical development for biologics.
• Strong expertise in chromatographic, spectroscopic, and bioassay techniques.
• Proven leadership and team management skills.
• Excellent communication and problem-solving abilities.

Preferred Experience:

• Experience with biosimilars, recombinant proteins, ADCs and peptides
• Hands-on experience with advanced mass spectrometry techniques.
• Knowledge of automation and digitalization in analytical workflows.