Senior Manufacturing Bioprocess Associate (Downstream)

Syngene International•Baltimore, MD

2d•Onsite

About The Position

The Senior Manufacturing Bioprocess Associate (Downstream) performs complex biologics manufacturing activities with minimal supervision. This role supports upstream or downstream operations including buffer/media preparation, process equipment operation, system setup, and sterilization support. Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.

Requirements

Associate or Bachelor degree in a science related field or equivalent relevant experience required.
Independently performs standard tasks 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.

Nice To Haves

Experience with Industry Applications such UNICORN, SAP, TrackWise, Delta V is preferred.

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.
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.
Propose and implement process improvements.
All other duties as assigned.