Scientist - ASAT

Role & responsibilities

Scientist - ASAT

About the Role:

We are seeking a highly motivated and experienced Scientist in Analytical Science and Technology (ASAT). This role will be responsible for analytical method transfer, validation, troubleshooting, and lifecycle management. The candidate would ensure compliance with internal quality systems and global regulatory standards.

Key Responsibilities:

• Engage in analytical method transfers and validations across internal and external sites.
• Manage and coordinate analytical activities at external laboratories, including troubleshooting activities and continuous improvement initiatives.
• Collaborate cross-functionally with Manufacturing Science & Technology team (MSAT), Analytical Development, Production, and Regulatory Affairs teams.
• Provide scientific and technical analytical support for MSAT, Quality Control, and Production functions.
• Review the analytical data, interpret and present to the stakeholders, ensuring data integrity and scientific rigor.
• Oversee lifecycle management of analytical methods, ensuring control of method performance and compliance with pharmacopeial standards.
• Support investigations related to deviations, changes, CAPAs, complaints, and OOS/OOE/OOT events.
• Compile and review analytical protocols, reports, ongoing process verification data, and regulatory submission documents.
• Foster quality culture, innovation, and operational excellence.

Essential Requirements:

• Masters or Ph.D. in Analytical chemistry, Biochemistry, or a related field.
• Minimum of 8-12 years of experience in analytical development or quality control.
• Strong expertise in method development and validation for biologics (e.g., mAbs, biosimilars, vaccines) using techniques such as HPLC, CE, ELISA, bioassays, etc.
• Deep understanding of ICH guidelines (Q2, Q12, Q14), pharmacopeial requirements (USP, EP), and global regulatory expectations.
• Proven track record of leading method transfers and resolving analytical issues in GMP compliant environment.
• Excellent project management, cross-functional communication.
• Experience working with external partners (CROs/CMOs) is highly desirable.