Downstream Bioprocess Associate – Biologics Manufacturing

Syngene International Limited; Baltimore (MD); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Syngene International Limited is seeking a Manufacturing Bioprocess Associate (Downstream) in Baltimore, MD to support downstream operations, including chromatography and TFF, under cGMP guidance. The role requires 2–4 years of biologics manufacturing experience and a science degree.

Expect an on-site schedule with potential 24/7 coverage to ensure batch success. Responsibilities include media preparation, system setup, cleaning and line clearance, and participation in process transfers and

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

• 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.
• Ensure strict adherence to cGMP standards, FDA/EMA regulatory requirements, and internal SOPs.
• 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
• Serve as the manufacturing support for new product introductions (NPI), working closely with MSAT and Process Development.
• Ensure facility and equipment readiness, documentation preparations (SOPs and Master Batch Records, and personnel training for new processes.
• Support execution of process performance qualification (PPQ) batches and readiness for commercial launch.
• 5S standards are maintained
• Propose and implement process improvements.

Skills

Biologics manufacturing experience

GMP documentation familiarity

Aseptic techniques

CDMO experience

Education

Science degree (Associate or Bachelor)

Job description

Syngene International Limited is seeking a Manufacturing Bioprocess Associate (Downstream) in Baltimore, MD to support downstream operations, including chromatography and TFF, under cGMP guidance. The role requires 2–4 years of biologics manufacturing experience and a science degree.

Expect an on-site schedule with potential 24/7 coverage to ensure batch success. Responsibilities include media preparation, system setup, cleaning and line clearance, and participation in process transfers and