R&D Downstream Process, Biosimilars

Intas

6 - 11 years

0 Lacs

ahmedabad

Posted:2 days ago| Platform:

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Summary

Execute downstream process development for biosimilar projects, including chromatography, filtration, tech transfer, scale-up, and data documentation, ensuring compliance with quality and regulatory standards.

Key Responsibilities

Perform downstream processing using AKTA chromatography (SEC, IEX, HIC, RP), filtration (TFF), virus validation, and cleaning validation.
Operate, troubleshoot, and optimize AKTA systems and downstream unit operations.
Support tech transfer, process scale-up, and characterization using QbD principles.
Prepare and review protocols, reports, and regulatory documents.
Collaborate cross-functionally with UPD, ADL, DPD, QA, and manufacturing teams.
Ensure accurate data recording, GLP adherence, and data integrity compliance.
Maintain lab instruments, calibration schedules, and inventory.
Address audit and DQA observations promptly.

Skills & Competencies

Hands-on experience with AKTA chromatography and related software.
Knowledge of chromatography (SEC, IEX, HIC, RP), filtration, virus clearance, and cleaning validation.
Familiarity with QbD, tech transfer, and regulatory compliance (CTD, GxP).
Strong documentation, communication, and data analysis skills.
Ability to work effectively in cross-functional teams.

Educational Qualification

M.Sc. / M.Tech in Biotechnology, Biochemical Engineering, or related field

Experience

14 years in downstream process development or related biopharma R&D

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