Job Title:
Job Location:
We're hiring! We are conducting Walk-in Drive in on 11 2025 () for multiple openings in Biopharmaceutical Operations.
Interview Location - Hyderabad
& : 11th Oct 2025, 09:00 AM to 12:00 PM
- : Syngene Scientific Solution Ltd. Knowledge Square Park - 9000, Plot No.7, Survey No.542, MN Park, Synergy Square 2, Genome Valley, Kolthur Shamirpet, Medchal, Hyderabad, Telangana 500078
Please find below the JD and share your confirmation for Walkin
About Syngene:
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
Industry Experience
- Minimum 1-10 years of relevant practical experience in mAbs
Upstream Manufacturing
Role-specific:
- Follow good aseptic behaviour inside Biologics operations facility.
- Perform all the upstream activities like Assembly preparation, Media Preparation, Vial thaw, Feed preparation and filtration, Bioreactor Operations to Batch Harvest.
- Monitoring and process control of the specific Operations of the upstream.
- Maintenance of Quality records.
- Traceability from raw material till finished product.
- In-process product sampling and storage.
- Preparation and review of operation related documents.
- Perform room owner responsibility for the assigned USP area.
- Perform equipment/instrument ownership related responsibilities related to USP.
- Initiate Complaint Slips (work orders) for USP related areas and equipment.
- Coordinate with QA for line clearance.
- LNS system monitoring and LN2 tank refilling.
- Gas Bank Monitoring.
- Maintaining process area All-time ready for Inspection/ audit purpose.
- Preparation of general upstream related procedures, protocols, risk assessment and BMRs.
- Execution of protocols related to upstream related activity and equipment / instrument qualification.
- General consumable stock review and record maintenance
- Ensure PM planner and calibration planner are followed.
- Execution of batch activity as per BMR and report nonconformity to the supervisor.
- Issuance of annexures, RM, consumables and BMRs.
- Tracking of work order status and ensuring timely closure.
- Involve in downstream related activities under supervision of downstream supervisor.
Downstream Manufacturing
Role-specific:
- Maintain good aseptic behaviour inside Biologics operations facility.
- Perform all the Downstream activities like Assembly preparation, accessories arrangement for step, Dispensing of raw materials and consumables, Reconciliation of excess and unused raw materials and consumables Buffer Preparation, Harvest Clarification, Chromatography operation, Low pH and Intermediate depth filtration, Viral filtration, TFF Operation and 0.2 filtration.
- Operating and cleaning of downstream equipment(s) as per standard operating procedures and EOP.
- Monitoring and process control of the specific Operations of the Downstream.
- Maintenance of Quality records.
- Perform In-process product sampling, sample submission and storage.
- Preparation and review of operation related documents.
- Perform room owner responsibility for the assigned DSP area.
- Perform equipment/instrument ownership related responsibilities related to DSP.
- Initiate Complaint Slips (work orders) for DSP related areas and equipment.
- Coordinate with QA for line clearance.
- Maintaining process area All-time ready for Inspection/ audit purpose.
- Maintain facility and assigned zone all-time ready for visit and audit.
- Involve and support in execution of batches as and when required and perform error free operation as per Batch Manufacturing Record (BMR).
- Involve in shipment of samples / final product as per packing and dispatch record.
- Work proactively to meet all document(s) on time closure requirement.
- Preparation of general Downstream related procedures, protocols, risk assessment and BMRs.
- Execute the protocols related to Downstream related activity and equipment / instrument qualification.
- Involve in Shipment of samples /final product as per packing and dispatch record.
- Preparation and periodic revision of equipment cleaning checklist (ECC)as ad when required.
- Execute the batch activity as per BMR and report nonconformity to the supervisor.
- Review of executed Documents on time.
- Issuance of annexures, RM, consumables and BMRs.
- Track the work order status and ensuring timely closure. Involve in upstream related activities under supervision of upstream supervisor.
Upstream Manufacturing Documentation
Role-specific:
- Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production.
- Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics.
- Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance.
- Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs).
- Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robustness and consistency in compliance with regulatory requirement.
- Prepare technology transfer protocols/descriptions and execute transfer to clinical and commercial manufacturing sites.
- Collaborate with downstream processing, analytical development, and quality assurance teams to ensure seamless integration of upstream processes.
- Liaise with regulatory affairs to ensure compliance with industry standards and guidelines.
- Analyze experimental data to draw meaningful conclusions and make data-driven decisions.
- Prepare and present technical reports, project updates, and scientific findings to senior management and stakeholders.
- Ensure that all upstream processes are compliant with cGMP, ICH, FDA, EMEA regulatory requirements.
- Prepare and review process descriptions and CMC sections of regulatory documents to support regulatory submissions as required for IND and BLA.
- Develop and implement strategic plans to achieve project milestones and goals.
- Mentor and develop team members to foster a high-performance culture
Downstream Manufacturing Documentation
Role-specific:
- Preparation, revision and review of Batch Manufacturing Records (BMR), Packing and Dispatch Record (PDR).
- Issue, Checking and Review of Operations documents.
- Preparation and review of Batch Manufacturing Records, SOPs, PDRs & Protocols.
- Conduct training for all DSP employees for prepared BMRs, PDRs and related documents.
- Review of TTDs, protocol and Quality Department Protocols related to Operations.
- Investigation of Batch failures in Operations.
- Monitor and follow good aseptic behavior inside BMP5 DSP Facility.
- Support in hiring process and bringing quality workforce to develop a team that is highly respected and engaged towards departmental goals.
- Update the batch progress in PRMs and participate in client discussions.
- Develop and implement operating methods and procedures designed to eliminate operating problems and improve manufacturing efficiency.
- Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance.
- Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs).
- Liaise with regulatory affairs to ensure compliance with industry standards and guidelines.
- Ensure that all DSP processes are compliant with cGMP, ICH, FDA, EMEA regulatory requirements.
- Develop and implement strategic plans to achieve project milestones and goals.
- Mentor and develop team members to foster a high-performance culture.
Equal Opportunity Employer
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, 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.
