Manufacturing Bioprocess MFG Lead; Downstream

Overview

Job Title: Manufacturing Bioprocess Lead (Downstream)

Reporting to: Supervisor, Manufacturing

About Syngene

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.

Job Summary

The Assistant Manager (Manufacturing Lead Associate) is a shift production lead in either upstream or downstream GMP production activities, depending on business need and assignment. Responsibilities include day-to-day operations in cell culture, bioreactor operations, harvest, media/buffer preparation, chromatography, TFF, filtration, single-use system assembly, glasswash, and autoclave support. This role ensures safe, compliant, and efficient execution of drug substance manufacturing processes and directly manages a team of manufacturing associates and leads.

1. Team Support & Oversight

• Provide direction to junior staff during batch execution.
• Support technology transfer efforts by assisting with SOP and M  drafting.
• Become SME on new equipment introduced during process changes or site expansions.
• Coordinate the execution of the manufacturing schedule through daily shift assignments and lead daily Tier huddles.
• Ensure appropriate escalation to management.

2. Manufacturing Operations/Compliance

• Perform complex upstream or downstream operations including bioreactor runs, chromatography, and TFF.
• Assemble systems for production including manifolds, filters, sensors, and tubing sets.
• Operate and coordinate glasswash and autoclave functions to ensure availability of sterile components.
• Monitor real-time process parameters and escalate deviations as needed.
• 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.
• Lead and support deviation investigations, root cause analysis, and implementation of effective CAPAs.
• Promote and enforce data integrity and robust documentation practices, including completion of batch records and change controls.
• Ensure cGMP compliance of batch records, logbooks, and cleaning documentation.
• Lead or contribute to deviation investigations, CAPA development, and quality documentation.
• Support 24/7 operations as needed, including off-shift or weekend coverage.

4. Process Introduction & Technology Transfer

• Serve as the manufacturing lead 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

• Establish 5S and Area ownership. Ensure 5S standards are maintained
• Propose and implement process improvements.
• Adhere and maintain Leader Standard Work

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

• Associate or Bachelor’s Degree in Life Sciences, Biotechnology, or Engineering preferred.
• 4+ years in biologics manufacturing in either upstream or downstream.
• Proficient with single-use bioreactor systems and media preparation techniques.
• Proficient with Filtration and Large scale Chromatography processes.
• Strong knowledge of cGMP, SOPs, and cleanroom operations.

• 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.

In this site-based role your work schedule may be fluid to support a 24/7 manufacturing operation, including weekends, nights, and holidays. Schedule changes may occur based on business needs.

During Routine production, the manufacturing supervisor is expected to be on the…