Career Category: Manufacturing & Operations

Experience Level: / sr.Executive (2-5 Years)/ asst manager

ROLE DESCRIPTION - CONJUGATION & RP HANDLING

This role is part of our GMP Manufacturing Operations team. You will be responsible for execution of bioconjugation processes and safe handling of compounds (RP/ Conjugation) under stringent containment and GMP environment.

Execute GMP manufacturing operations for Conjugation:

linker- conjugation, UF/DF (TFF), sterile filtration.

- Handle of (RP) procedures.

- AKTA/ RP chromatography systems, TFF skids, and filtration assemblies.

- Ensure real-time documentation in BMR/BPR, logbooks as per GDP principles.

- Perform line clearance, CIP/SIP, decontamination, and deactivation as per SOP.

- Monitor and control Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) like DAR, aggregation, residual solvents.

- Participate in Technology Transfer, Process Validation, Cleaning Validation, and Scale-up activities.

- Drive a culture of safety, quality and compliance. Support Deviation, Change Control, CAPA and Risk Assessment (FMEA).





- Collaborate with cross-functional teams - QA, QC, MSAT, Engineering, EHS, and Warehouse.

Basic Qualifications:

- M.Sc. in Biotechnology / Biochemistry / Microbiology /B.Tech /M.Tech in Biotech / Chemical Engineering

- 2 to 5 years of hands-on experience in Biologics manufacturing

Preferred Qualifications & Skills:

- Direct experience in Conjugation / Bioconjugation / PEGylation / manufacturing

experience in RP Handling,

- Equipment: RP systems, DAC colums,(DAC50,100, 450 mM etc),AKTA Pure/Avant, TFF (Repligen/Pall), pH/Conductivity, Single-use mixers/bags

- Robust knowledge of cGMP, GDP, Cleanroom gowning (Grade B/C/D), Data Integrity

- Understanding of analytical techniques: SEC, HIC, RP analysis

Excellent documentation, communication, and audit-facing skills.

Pay: ₹400,000.00 - ₹550,000.00 per year

Benefits:

- Food provided
- Health insurance
- Provident Fund

Work Location: In person

📌 Manufacturing & Operations (India)
🏢 Amogen Pharma
📍 India