Job Description

Aragen Biologics is hiring for Downstream Process Development for monoclonal antibodies, inviting professionals with 3–6 years of experience in biologics domains.

Education: M.Sc/Mtech 3–6-year experience
BE: 6-7 years’ experience.
Job Summary:
The candidate will be responsible for the development, optimization, and scale-up of downstream purification processes for monoclonal antibodies. The role involves hands-on execution of chromatography and filtration experiments, process characterization, viral clearance support, and technology transfer to manufacturing.
Key Responsibilities
Downstream Process Development
Develop and optimize mAb purification processes including Protein A capture, low pH viral inactivation, polishing chromatography (AEX, CEX, HIC), and UF/DF
Perform resin screening, process optimization, and resin lifetime studies
Design and execute DoE, robustness, and process characterization studies
Support scale-up and tech transfer to pilot and GMP manufacturing
Execute and support viral clearance studies (VCS) including nanofiltration and chromatography steps
Evaluate and control critical process parameters (CPPs) and their impact on critical quality attributes (CQAs).
Required Technical Skills
·      Hands-on experience with ÄKTA systems and chromatography columns
·      Strong knowledge of Protein A chromatography and polishing strategies
·      Experience with UF/DF systems (TFF, cassette or hollow fiber)
·      Understanding of viral clearance principles and ICH Q5A expectations
·      Knowledge of biophysical and biochemical characterization of mAbs
Soft Skills & Documentation & Compliance
·      Strong experimental planning and data analysis skills
·      Good technical writing and documentation capability
·      Ability to work independently and in cross-functional teams
·      Effective communication and problem-solving skills.
·      Maintain contemporaneous, accurate, and traceable laboratory notebook records in compliance with ALCOA+ principles
Ensure data integrity through proper documentation practices, data review, audit trail compliance, and adherence to internal SOPs and regulatory guidelines

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