Manufacturing Bioprocess Associate; Downstream

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Date: 27 Aug 2026

Location:

Baltimore, MD, US, 21224

Division:
Manufacturing Services

Job Title: Manufacturing Bioprocess Associate (Downstream)

Reporting to: Supervisor, Manufacturing

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

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.

The Senior Executive (Senior Manufacturing Associate) 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.

1. Manufacturing Operations

• 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 (M ) under cGMP and document all operations clearly using SOPs and batch records.

3. Quality/Compliance

• Execute Master Batch Records (M ) under cGMP, and document in detail through the use of SOPs and MBRs for the processes and manufacturing steps.
• 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

4. Process Introduction & Technology Transfer

• 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.

5. Continuous Improvement & Operational Excellence

• 5S standards are maintained
• Propose and implement process improvements.

The responsibilities listed below represent the core expectations of the role; however, this is not an all-inclusive list. The Senior Executive may be assigned additional duties and responsibilities as business needs evolve.

• 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…