About this role
JOB DESCRIPTION Job Title
Downstream Associate Job Location: Bangalore Department: Biopharmaceutical operation About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. 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 Mandatory expectation for all roles as per Syngene safety guidelines Execute and supervise Batch activities in accordance with BMRs and established protocols.
Prepare, revise, execute, and review Batch Manufacturing Records (BMRs)/PDR/SOPs/Protocols. Having strong knowledge of Chromatography techniques, UFDF, Column packing-unpacking. Should be well versed with continuous centrifugation, Homogenizer, and single-use technology. Collaborate with Process Development, MSAT, and Operational Excellence teams for process scale-up and technology transfer activities. Prepare and review qualification documents as per SOPs, ensuring timely review and approval with cross-functional teams. Execution of Installation, Operational, and Performance Qualification (IQ/OQ/PQ) for downstream equipment.
Coordinate Commissioning & Qualification activities through collaboration with internal and external cross-functional teams and subject matter experts (SMEs). Coordinate with the maintenance department for the upkeep of operational equipment. Ensure all operational documents, batch records, and checklists are compliant with cGMP Should have good knowledge about process mapping and equipment mapping as per project requirements. Coordination with the client for finalization of process requirements and address client quarries related to project.
Manage the stock of required consumables for batch activities and ensure timely procurement. Prepare and review quality protocols and investigate any batch failures in operations. Support the facility's readiness for regulatory inspections. Having strong knowledge of QMS activities (Change Control, Deviation, CAPA, Investigation, etc.) Report deviations and manage change controls, collaborating with QA to implement corrective actions. Carry out additional tasks as assigned by the HOD. Preparation of qualification documents URS, SLIA, Validation Plan, System Boundary, CLIA, DQ, RA, RTM, IQ, OQ and PQ and applicable deliverables based on qualification procedure.
Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar and monitor & confirm the same for the reports. Attend all assigned mandatory trainings related to data integrity, health, and safety measures, and monitor & confirm the same for the reports. Participate in & support the trainings on procedures, protocols, and On-the-Job activities. Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security, and monitor & confirm the same for the reports.
Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety and monitor & confirm the same for the reports. Understand all necessary safety protocols and always follow the same to ensure safety for all and monitor & confirm the same for the reports. Proactively identify near-misses & potential incidents and communicate the same to supervisor and/or line manager or through the respective portals and disseminate learnings from those to the team members & any other concerned personnel to prevent recurrence of such events.
Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Experience 1 to 5 Years of Relevant hands-on experience in downstream process and should possess strong knowledge downstream manufacturing operations, including purification processes, equipment operation, process monitoring, and cGMP compliance. Skills and Capabilities Working knowledge of downstream purification principles is essential for this role. Proficient in handling AKTA & TFF Systems. Experience in continuous centrifugation, Homogenizer, and single-use technology is preferable. Knowledge on cleaning validation and PPQ batch is preferable not mandatory. Experience in QMS activities (Change Control, Deviation, CAPA, Investigation, etc.). Education Bachelor's or Master's degrees in Life Sciences, Biotechnology, Bioprocess or related field.
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.