Job Description

Aragen Biologics is hiring for Analytical Development (LC-MS and Chromatography techniques), inviting professionals with 8–12 years of experience in biologics domains.

Position: Manager
Education: Master’s or Ph.D. in Biotechnology/ Biochemistry.
Experience:
8–12 years in analytical development with strong exposure to LC-MS and LC techniques.
Prior experience in CDMO or biopharma environment preferred.
Role Summary:
The Manager will take care of analytical development activities focused on LC-MS and LC-based techniques for biologics and complex molecules in a CDMO (Contract Development and Manufacturing Organization) setting. This role involves method development, Method Qualification Method Transfer, Method validation, and troubleshooting to support formulation development, characterization, and regulatory submissions.
Method Development, Qualification, Transfer & Validation:
Design and execute robust LC-MS and LC-based analytical methods for characterization, impurity profiling, and stability studies.
Hands on experience on Method Qualification Method Transfer, Method validation, and troubleshooting the analytical methods
Ensure compliance with ICH, USP, and regulatory guidelines.
Project Leadership:
Manage analytical deliverables for multiple client projects in alignment with timelines and quality standards.
Collaborate with cross-functional teams (Formulation, Process Development, QA/QC).
Strong project management and client communication skills.
Ability to lead teams and manage multiple priorities.
Technical Expertise:
Apply advanced LC-MS techniques for Intact and Reduced mass, peptide mapping, glycan analysis, Disulphide Linkage conformation, Spent media analysis and identification of post-translational modifications.
Candidate should have strong experience on method development of Chromatography techniques for biological molecules.
Documentation & Compliance:
Prepare protocols, reports, and regulatory documentation (IND, BLA, NDA).
Ensure adherence to GLP/GMP and data integrity principles.
Team Development:
Mentor and train junior scientists on LC-MS and LC techniques.
Drive continuous improvement and innovation in analytical workflows.

Interested can share the resume to prashanth.cherugad@aragen.com