Analytical Development Lead

Job Summary : We are seeking an experienced Analytical Sciences professional to lead a team of scientists and drive analytical strategy for biosimilar product development in the R&D Centre at Chennai. This role involves partnering with project leads and cross-functional teams to deliver high-quality analytical data, support regulatory submissions, and ensure smooth execution of laboratory operations. The ideal candidate brings strong expertise in chromatographic and electrophoretic methods, specifically HPLC, GC, CE, and SDS-PAGE. Additionally, the ability to develop and implement robust analytical methods, including method validation, transfer, and verification is essential. Furthermore, experience with data analysis software such as Excel, R, or Python is desirable. The successful candidate will have a strong understanding of regulatory requirements for biosimilar product development, including ICH guidelines and FDA regulations. This role requires excellent communication and collaboration skills, with the ability to work effectively across multiple disciplines and levels within the organization. The Analytical Development Lead will be responsible for leading a team of scientists, providing guidance on analytical strategies, and ensuring compliance with regulatory requirements. Key responsibilities include: • Developing and implementing robust analytical methods for biosimilar product development. • Providing scientific expertise and guidance to project teams on analytical strategy and method development. • Collaborating with cross-functional teams to deliver high-quality analytical data in support of regulatory submissions. • Ensuring smooth execution of laboratory operations, including quality control and assurance. • Maintaining accurate records and documentation of analytical methods and results. • Staying up-to-date with industry trends, regulatory requirements, and scientific advancements in the field of biosimilar product development. The successful candidate will have a Ph.D. or equivalent degree in Analytical Sciences, Biochemistry, Chemistry, or related fields, with at least 5 years of experience in analytical sciences, preferably in the biopharmaceutical industry. • Strong expertise in chromatographic and electrophoretic methods, specifically HPLC, GC, CE, and SDS-PAGE. • Experience with data analysis software such as Excel, R, or Python is desirable. • Strong understanding of regulatory requirements for biosimilar product development, including ICH guidelines and FDA regulations. • Excellent communication and collaboration skills, with the ability to work effectively across multiple disciplines and levels within the organization.