JOB DESCRIPTION

Job Title: Lead Analytical Development

Job Location: Bangalore

Department: Biopharmaceutical Development

About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines
- Lead the Analytical and Characterization strategy for late-stage clinical and commercial programs, ensuring assays are fit-for-purpose for validation and regulatory submission.
- Oversee the design, development, optimization, and qualification of in-process, lot release, biophysical and MS methods to support product release and characterization.
- Accountable for defining analytical study plan including,



method development, in-process analytics, stage-wise testing for Cell Line/Bioprocess/Formulation development in consultation with client and cross-functional teams
- Partner closely with CMC, Quality, Regulatory, and Manufacturing teams to ensure seamless assay transfer, validation, and lifecycle management.
- Serve as the subject matter expert in regulatory interactions, authoring and reviewing CMC sections of INDs, BLAs, and other submissions.
- Execute data analysis, create technical reports and co-ordinate project execution with cross-functional teams
- Manage and mentor a high-performing team of scientists, fostering technical excellence, innovation, and qualified growth.
- Drive continuous improvement in method robustness, throughput, and compliance with ICH and USP guidelines.
- Collaborate with external partners, CROs, and contract manufacturers to ensure assay consistency across globa

📌 Biologics- Analytical Lead 1 (Bengaluru)
🏢 Syngene
📍 Bengaluru