Manufacturing Bioprocess Associate (Downstream)

About the role

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. The Senior Executive (Senior Manufacturing Associate) performs complex biologics manufacturing activities with minimal supervision, supporting downstream operations including chromatography and tangential flow filtration (TFF).

Responsibilities

• Execute downstream unit operations (chromatography, TFF) in accordance with batch requirements.
• Prepare and test buffer/media 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.
• Contribute to deviation investigations, CAPA development, and quality documentation.
• Support 24/7 operations as needed, including off-shift or weekend coverage.
• Serve as 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.
• Maintain 5S standards and propose/implement process improvements.

Qualifications

• Associate or Bachelor degree in a science-related field or equivalent relevant experience required.
• 2–4 years of biologics manufacturing experience, with downstream (purification) expertise preferred.
• Working knowledge of GMP documentation, cleanroom behavior, and aseptic techniques.
• Experience with new facility startup, equipment commissioning/qualification.
• Deep understanding of downstream (purification) unit operations for biologics manufacturing.
• Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment.

Additional Requirements

• 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.
• Requires good eye/hand coordination, visual acuity, and proficiency with keyboards, computers, and phones.
• Sensory awareness (smell, sound) is important for safety and quality assurance.
• Physical competencies include maintaining a stationary position, moving within the facility, climbing, reaching, safely operating hand tools, and performing repetitive movements.
• Ability to move or transport required loads and work in environments with extreme temperatures, high noise levels, restricted laboratory access, and exposure to dust, gas, fumes, steam, or chemicals.
• Role may require approximately 5% to 10% travel, including international travel based on business needs.