Bioprocess Downstream Associate – 24/7 Operations

Initial Therapeutics, Inc.; Baltimore (MD); On-site; USD 70,000 - 90,000; Full time

Job summary

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

This role supports downstream operations, including chromatography and TFF, and requires adherence to cGMP, FDA/EMA standards, and SOPs. Responsibilities include media preparation, equipment operation, process validation support, and meticulous documentation.

Qualifications

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

Responsibilities

• Execute upstream (seed train, bioreactor) or downstream (chromatography, TFF) unit operations in accordance with batch requirements.
• Prepare and test media or buffer solutions following SOPs and batch instructions, including pH and conductivity adjustments.
• Operate and maintain glass wash and autoclave systems to ensure proper sterilization and availability of process components.
• Assist in system setup, tubing configurations, and filter integrity testing.
• Perform cleaning, sanitization, and line clearance of equipment and cleanroom areas.
• Execute Master Batch Records (MBR) under cGMP and document all operations clearly using SOPs and batch records.
• Support deviation investigations, root cause analysis, and implementation of effective CAPAs.
• Adhere to data integrity and robust documentation practices, including completion of batch records and change controls.
• Ensure cGMP compliance of batch records, logbooks, and cleaning documentation.
• Contribute to deviation investigations, CAPA development, and quality documentation.
• Support 24/7 operations as needed, including off-shift or weekend coverage.
• All other duties as assigned

Skills

Biologics manufacturing

GMP documentation

Cleanroom behavior

Aseptic technique

Equipment startup

Education

Bachelor's degree in science

Associate degree in science

Job description

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

This role supports downstream operations, including chromatography and TFF, and requires adherence to cGMP, FDA/EMA standards, and SOPs. Responsibilities include media preparation, equipment operation, process validation support, and meticulous documentation.