Syngene International is hiring experienced professionals for the position of Analytical SME – Biologics in Bangalore, Karnataka. This role offers an excellent opportunity to work with a leading contract research, development, and manufacturing organization (CRDMO) specializing in innovative scientific solutions for global pharmaceutical and biotechnology companies.
Professionals with expertise in monoclonal antibodies (mAbs), analytical method development, validation, and transfer are encouraged to apply. The position is part of Syngene’s Biopharmaceutical Development team and offers exposure to cutting-edge biologics research and development projects.
Job Overview
| Details | Information |
|---|---|
| Position | Analytical SME – Biologics |
| Company | Syngene International |
| Department | Biopharmaceutical Development |
| Location | Bangalore |
| Employment Type | Full-Time |
| Education | Master’s Degree in Life Sciences, Biotechnology, Chemical Engineering, or related field |
| Experience | Experienced Professionals |
| Industry | Biologics / Biopharmaceutical Development |
Key Responsibilities
The selected candidate will be responsible for:
- Developing, qualifying, implementing, and transferring analytical methods from R&D to Quality Control and Manufacturing teams.
- Performing analytical testing of samples from upstream, downstream, formulation, QC, and production processes.
- Conducting data generation, analysis, interpretation, and documentation following quality standards.
- Preparing analytical reports, technical summaries, and scientific documentation.
- Maintaining accurate records using Electronic Lab Notebooks (ELN) and Electronic Document Management Systems (EDMS).
- Supporting method validation and technology transfer activities.
- Leading analytical teams and mentoring junior scientists.
- Participating in quality investigations, CAPA implementation, and compliance initiatives.
- Ensuring laboratory compliance with 5S, GMP, and quality management systems.
- Managing laboratory inventories, consumables, and instrument maintenance activities.
- Collaborating with cross-functional teams to achieve project objectives.
Required Qualifications
Educational Qualification
- Master’s Degree in:
- Biotechnology
- Life Sciences
- Chemical Engineering
- Related Scientific Disciplines
Experience Requirements
Candidates should possess:
- Extensive experience in biologics analytical development.
- Strong expertise in analytical techniques such as:
- Liquid Chromatography (LC)
- Capillary Electrophoresis (CE)
- Process impurity analysis
- Excipient analysis
- Experience working with monoclonal antibodies (mAbs).
- Proven experience in:
- Method Development
- Method Validation
- Method Transfer to QC
- Team leadership experience.
- Strong communication and collaboration skills.
Preferred Skills
- Knowledge of Electronic Lab Notebooks (ELN).
- Experience with Electronic Document Management Systems (EDMS).
- Familiarity with TrackWise or similar Quality Management Systems (QMS).
- Strong scientific writing and technical reporting abilities.
- Problem-solving and troubleshooting expertise in analytical laboratories.
Why Join Syngene?
- Opportunity to work with one of India’s leading CRDMOs.
- Exposure to global biologics and biopharmaceutical projects.
- Collaborative and innovation-driven work environment.
- Career growth opportunities in analytical development and biologics research.
- Strong focus on employee safety, quality, and professional development.
- Opportunity to lead high-impact scientific projects.
Keywords
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