Job Title: Scientist Downstream Process development
Job Location: Bangalore
Department: Biopharmaceutical Development
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
Assist in Designing and optimization of purification processes for novel fusion antibodies, ensuring scalability and robustness.
Planning and execution of experiments for late-phase process development, process characterization, and lifecycle management activities.
Support the DSP team with basic activities such as preparation of buffers, column packing and evaluation.
Maintain real-time electronic lab notebook documentation in compliance with data integrity standards.
Actively contribute to process scale-up and technology transfer to GMP manufacturing facilities.
Involve in process characterization efforts, including parameter classification and establishment of control strategies.
Author, review protocols, reports, scale up & scale down studies, tech transfer documents, deviation and executed Batch records.
Troubleshoot purification workflows using ÄKTA Pure and TFF systems, implementing sustainable improvements to the purification platform.
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Compile and analyze experimental data, delivering data-driven insights and technical reports.
Present findings and contribute to team discussions and weekly project meetings.
Collaborate with cross-functionally to promote knowledge sharing, best practices, and continuous improvement initiatives.
Ensure adherence to 5S laboratory standards and maintain an organized work environment.
Supporting in breakdown management of downstream equipment and serve as point of contact to ensure smooth functioning of instruments.
Facilitate procurement and inventory management of raw materials and consumables, ensuring uninterrupted lab operations.
Actively participate in quality related investigations and propose effective corrective and preventive actions.
Ensure compliance with documentation and archival processes (lab notebooks, logbooks, protocols, reports) in electronic systems.
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Experience
Relevant hands-on experience in downstream process development, particularly in monoclonal antibody (mAb) purification, is essential for this role.
Skills and Capabilities
Working knowledge of downstream purification principles is essential for this role.
Proficient in handling of AKTA & TFF Systems.
Experience in scale-up and tech transfer is preferable.
Knowledge on Process characterization, control strategy and PPQ batch is preferable not mandatory.
Experience in using electronic lab notebook, Electronic Database Management System (EDMS), TrackWise is preferable not mandatory.
Education
Master’s degree in Life Science, Biotechnology, 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.
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