Upstream Manufacturing Documentation

3 days ago


Bangalore Karnataka, India Syngene International Full time

Designation Upstream Manufacturing Documentation Job Location Bangalore About Syngene Syngene 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 Key Result Areas 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 Education Master s degree bachelor s degree in pharmacy master s degree in Pharmaceutical Sciences Industry Experience Minimum 5 -10 years of relevant practical experience in mAbs Upstream process and documentation Other competencies required for the role Excellent problem-solving skills and ability to work in a fast-paced collaborative environment Experience with automation and data analysis tools applied for cell culture bioprocessing Familiarity with regulatory submissions and quality systems in the biopharmaceutical industry Strong interpersonal skills with ability to work with internal and external stakeholders Excellent written and verbal communication skills for regulatory documentation and presentations Strong knowledge of bioprocessing principles cell culture techniques and scale-up methodologies Perform review of protocols study protocols equipment qualification protocols etc Review the executed protocols and provide adequate support for timely closure of the same Preparation of general upstream related procedures protocols risk assessment and BMRs On-time initiation closure of deviations investigations CAPA and change controls Safety and DI Responsibilities Adhere to organizational policies procedures on EHSS POSH Data Integrity and IT security Always wear the applicable PPEs and adhere to any other Environment Health and Safety EHS requirements in the workplace for individuals lab plant safety Understand all necessary safety protocols and always follow the same to ensure safety for all Proactively identify near-misses potential incidents and communicate to supervisor and or line manager or through the respective web portals 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 Pls visit us at to know more about us and what we do



  • Bangalore, Karnataka, India Syngene International Full time

    Job Title Upstream Manufacturing Job Location Bangalore About Syngene Syngene 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...


  • Bangalore, Karnataka, India Syngene International Full time

    Designation Downstream Manufacturing Documentation Job Location Bangalore About Syngene Syngene 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 ...


  • Bangalore, Karnataka, India Syngene International Full time

    Designation Downstream Manufacturing Job Location Bangalore About Syngene Syngene 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...

  • Executive

    1 week ago


    Bangalore, Karnataka, India Syngene International Full time

    Key Result Areas Role-specific Active involvement in all upstream manufacturing activities Perform error free operation by eliminating operational gaps in advance Active trouble shooting to minimize the various risks prior to execution and during execution Initiate and process upstream deviations investigations and closure Pre -execution activity ...


  • Bangalore, Karnataka, India Schneider Electric Full time

    SUMMARY OF JOB As a member of the Secure Power Division Supply Chain Methods Tools team the Manufacturing Systems Engineer will assist the effort to ensure effective set up and use of our primary Manufacturing platforms This will include a general level of awareness and knowledge of manufacturing applications a specific knowledge on MES ATE LabVIEW ...


  • Bangalore, Karnataka, India Syngene International Full time

    JOB ROLE DESCRIPTION The Company Syngene International Ltd BSE 539268 NSE SYNGENE ISIN INE398R01022 is an integrated research development and manufacturing solutions company serving the global pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical sectors Syngene s 4500 scientists offer both the skills...


  • Bangalore, Karnataka, India Syngene International Full time

    Designation Associate Manager Job Location Bangalore Job Grade 7-1 Associate Manager The Company Syngene International Ltd BSE 539268 NSE SYNGENE ISIN INE398R01022 is an integrated research development and manufacturing solutions company serving the global pharmaceutical biotechnology nutrition animal health consumer goods and...


  • Bangalore, Karnataka, India Schneider Electric Full time

    Mission Identify non-quality factors continuously conduct or have other departments conduct in-depth analyses and monitor quality improvement plans Identify potential issues before they occur and implement preventive solutions Solve quality manufacturing issues affecting customers quickly and effectively through containment correction and prevention...


  • Bangalore, Karnataka, India Fictiv Full time

    Fictiv Exists to Enable Hardware Innovators to Build Better Products Faster Fictiv coined the AWS of manufacturing is a leading technology company transforming the 350 billion manufacturing industry Our cutting-edge cloud platform uses AI and machine learning algorithms to help companies build hardware at the speed of software Come join our growing...


  • bangalore, India Green HR Solutions Full time

    Hiring for USA based big MNC, pls Apply if following Job Description suits your aspirations.We are looking for a detail-oriented and innovative Manufacturing Engineer to join our production team. The Manufacturing Engineer will be responsible for designing, implementing, and improving manufacturing processes, equipment, and workflows to increase efficiency,...