Downstream Bioprocess Manufacturing Specialist

BioSpace; Baltimore (MD); On-site; USD 60,000 - 90,000; Full time

Job summary

Syngene International Ltd. seeks a Manufacturing Bioprocess Associate (Downstream) to support downstream operations including chromatography and TFF, and to assist with buffer/media preparation and sterilization processes on a 24/7 manufacturing floor.

The role emphasizes strict cGMP adherence, batch records, and robust quality documentation, with collaboration across MSAT and Process Development to transfer processes and drive continuous improvement in biologics manufacturing.

Qualifications

• Associate or Bachelor degree in a science related field or equivalent relevant experience 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 (cell culture/fermentation) and downstream (purification) unit operations for biologics manufacturing.
• Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment.

Responsibilities

• Manufacturing Operations: Execute upstream or downstream unit operations according to batch requirements.
• Prepare and test media or buffer solutions with SOPs and batch instructions.
• Operate and maintain glass wash and autoclave systems for sterilization and availability of 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 with SOPs and batch records.
• Ensure strict adherence to cGMP standards, FDA/EMA regulatory requirements, and internal SOPs.
• Support deviation investigations, root cause analysis, and CAPA implementation.
• Contribute to data integrity and robust documentation; complete batch records and change controls.
• Support 24/7 operations as needed, including off-shift or weekend coverage.
• Process Introduction & Technology Transfer: Support NPI manufacturing, work with MSAT and Process Development.
• Ensure facility and equipment readiness, documentation preparations (SOPs and MBRs), and training for new processes.
• Support execution of PPQ batches and readiness for commercial launch.
• Continuous Improvement & Operational Excellence: Maintain 5S standards and propose process improvements.

Skills

GMP documentation

Aseptic techniques

CDMO experience

Education

Associate or Bachelor degree in science

Tools

Equipment commissioning

Job description

Syngene International Ltd. seeks a Manufacturing Bioprocess Associate (Downstream) to support downstream operations including chromatography and TFF, and to assist with buffer/media preparation and sterilization processes on a 24/7 manufacturing floor.

The role emphasizes strict cGMP adherence, batch records, and robust quality documentation, with collaboration across MSAT and Process Development to transfer processes and drive continuous improvement in biologics manufacturing.