Manufacturing Supervisor (Downstream)

Job Title: Supervisor, MFG

Reporting to: Associate General Manager, MFG

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 Manufacturing Supervisor (Downstream) oversees 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. Responsibilities include day-to-day operations in cell culture, bioreactor operations, harvest, media/buffer preparation, chromatography, TFF, filtration, and single-use system assembly. This role ensures safe, compliant, and efficient execution of drug substance manufacturing processes and directly manages a team of manufacturing associates and leads.

Primary Responsibilities:

1. Leadership & Team Management

• Supervise manufacturing activities across shifts.  Ensure delegated tasks are completed safely and compliantly. 
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHS) mindset as well as the highest standards of quality, integrity, and compliance.
• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.
• Monitor team performance.
• Lead and support your team in operational readiness tasks as required, such as SOP and Batch record generation, review/approval, team onboarding, and materials management.
• Drive and Support cross-training and develop robust team capability matrices.
• Participate in technology transfer activities including drafting and reviewing SOPs and Master Batch Records.
• Serve as subject matter expert (SME) for new equipment and processes during tech transfer and qualification phases.

2. Manufacturing Operations

• Oversee upstream or downstream operations including bioreactor runs, seed train, harvest, chromatography, viral filtration, and UF/DF.
• Manage and verify preparation of media or buffer solutions including weighing, pH/conductivity adjustment, and sterile filtration.
• Ensure proper assembly, cleaning, and readiness of single-use systems, manifolds, skids, bioreactor or purification equipment.
• Oversee and support glasswash and autoclave operations for preparation and sterilization of process components.
• Support 24/7 operations as needed, including off-shift or weekend coverage.

3. Quality & Compliance

• Execute Master Batch Records (MBR) under cGMP, and document in detail through the use of SOPs and MBRs for the processes and manufacturing steps.
• Support equipment readiness including calibration checks and control system operation (e.g., DeltaV).
• Execute Master Batch Records (MBR) 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.

4. Process Introduction & Technology Transfer

• 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

• Establish and Sustain 5S, Lean, and operational efficiency initiatives.
• 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 Supervisor may be assigned additional duties and responsibilities as business needs evolve.

Education & Qualifications:

• Bachelor’s in Life Sciences, Biotechnology, or Engineering preferred.
• 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.
• 5+ years in biologics manufacturing with at least 2 years in a supervisory role.
• Hands-on experience with upstream (bioreactors, media prep) and/or downstream (chromatography, buffer prep) operations.
• Strong working knowledge of cGMP, cleanroom operations, and automation platforms (e.g., Unicorn).
• Experience with new facility startup, equipment commissioning/qualification.
• Deep understanding of upstream (cell culture/fermentation) and/or downstream (harvest/purification) unit operations for biologics manufacturing.
• Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment.
• Skilled in managing diverse teams, resolving conflicts, and promoting employee engagement.

Additional requirements for this role:

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 manufacturing floor at least %70 of the time.

In this site-based supervisory role, you will be responsible for organizing, coordinating, and directing daily manufacturing operations while providing occasional support during off-hours or on weekends as dictated by production demands (approximately 5% to 10% of the time, with potential for international travel). The position requires the ability to comprehend and follow instructions, independently make quick decisions to solve complex issues, and consistently apply sound judgment in a dynamic environment. Strong analytical skills are essential for interpreting data and information to drive continuous process improvements. You will lead and supervise teams, managing others effectively even when faced with frequent interruptions and shifting priorities.

The role demands good eye/hand coordination, visual acuity, and proficiency in using keyboards, computers, and phones. Sensory awareness—including the ability to detect and distinguish smells and sounds—is important for safety and quality assurance. Physical competencies such as maintaining a stationary position, moving or traversing the facility, ascending or descending (climbing), reaching, and safely operating hand tools and performing repetitive movements are integral, as is the ability to move or transport required loads.

A commitment to regular and predictable attendance is necessary, as is the flexibility to work irregular hours that often include nights and weekends. The position involves working in environments with extreme temperatures, high noise levels, restricted laboratory access, and exposure to dust, gas, fumes, steam, or chemicals. This multifaceted role supports the organization’s operational continuity and ensures safety and efficiency across all aspects of manufacturing leadership.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.