Downstream Bioprocess Operator — Manufacturing Excellence

Initial Therapeutics, Inc.; Baltimore (MD); On-site; USD 60,000 - 90,000; Full time

Job summary

Syngene International Ltd. is seeking a Manufacturing Bioprocess Associate (Downstream) to perform complex biologics manufacturing activities with minimal supervision.

The role supports downstream operations including chromatography and TFF, and requires strong GMP documentation and cleanroom practices. The candidate will work on process equipment operation, media preparation, system setup, and sterilization support, contributing to cGMP batch records and continuous improvement initiatives.

Qualifications

• Associate or Bachelor degree in a science-related field is required.
• 2–4 years of biologics manufacturing experience (upstream or downstream).
• Working knowledge of GMP documentation, cleanroom behaviour, and aseptic techniques.
• Experience with new facility startup, equipment commissioning/qualification.
• Deep understanding of upstream and downstream unit operations for biologics manufacturing.
• Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment.

Responsibilities

• Execute upstream or downstream unit operations per batch requirements.
• Prepare and test media/buffer solutions, including pH/conductivity adjustments.
• Operate and maintain sterilization systems and perform cleaning, sanitization, and line clearance.
• Document Master Batch Records under cGMP using SOPs and batch records.
• Support 24/7 operations and assist in process transfers and tech transfer activities.

Skills

GMP documentation

Aseptic techniques

Cleanroom behaviour

Safety-consciousness

Education

Associate or Bachelor degree in a science-related field

Tools

Equipment commissioning/qualification

Job description

Syngene International Ltd. is seeking a Manufacturing Bioprocess Associate (Downstream) to perform complex biologics manufacturing activities with minimal supervision.

The role supports downstream operations including chromatography and TFF, and requires strong GMP documentation and cleanroom practices. The candidate will work on process equipment operation, media preparation, system setup, and sterilization support, contributing to cGMP batch records and continuous improvement initiatives.