Manufacturing Bioprocess Associate (Downstream)

About the role

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.

Primary Responsibilities

• Maintain sterile environments and execute 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.
• Absorb and 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.
• 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.

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.

Continuous Improvement & Operational Excellence

• Maintain 5S standards.
• Propose and implement process improvements.

Education & 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 behavior, 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.

Additional Requirements for This Role

• Your work schedule may be fluid to support a 24/7 manufacturing operation, including weekends, nights, and holidays.
• During Routine production, the manufacturing supervisor is expected to be on the manufacturing floor at least 75% of the time.
• The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
• The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.