This opportunity is suitable for professionals with expertise in biologics analytical development, monoclonal antibodies (mAbs), analytical method development, validation, and technology transfer.
The role provides an opportunity to work on advanced biopharmaceutical development projects and support global pharmaceutical and biotechnology programs.
Job Overview
| Particulars | Details |
|---|---|
| Position | Analytical SME – Biologics |
| Company | Syngene International |
| Location | Bangalore, Karnataka, India |
| Job Type | Full-Time |
| Experience | Fresher |
| Category / Department | Pharma |
| Application Mode | Online |
🏢 About Syngene International
Syngene International is a leading contract research, development, and manufacturing organization (CRDMO) providing integrated scientific solutions to global pharmaceutical, biotechnology, and healthcare companies.
The company focuses on innovation, scientific excellence, quality systems, and developing advanced solutions across drug discovery, development, and manufacturing.
📝 Job Description
Syngene International Hiring | Analytical SME – Biologics | Biopharmaceutical Development Jobs
🏢 Company: Syngene International
💼 Position: Analytical SME – Biologics
📍 Location: Bangalore, Karnataka, India
🧪 Department: Biopharmaceutical Development
🎓 Qualification: Master’s Degree in Biotechnology / Life Sciences / Chemical Engineering / Related Scientific Disciplines
📄 Employment Type: Full-Time
💻 Application Mode: Online Application
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📌 Job Details
Company: Syngene International
Position: Analytical SME – Biologics
Department: Biopharmaceutical Development
Location: Bangalore, Karnataka
Employment Type: Full-Time
Industry: Biologics / Biopharmaceutical Development
Experience: Experienced Professionals
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🎓 Required Qualifications
Candidates should have:
✔ Master’s Degree in Biotechnology
✔ Life Sciences
✔ Chemical Engineering
✔ Related Scientific Disciplines
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🧬 Experience & Technical Skills
✔ Strong experience in biologics analytical development.
✔ Knowledge of analytical techniques including:
• Liquid Chromatography (LC)
• Capillary Electrophoresis (CE)
• Process impurity analysis
• Excipient analysis
✔ Experience with monoclonal antibodies (mAbs).
✔ Hands-on experience in:
• Analytical Method Development
• Method Validation
• Method Transfer to QC
✔ Experience in analytical laboratory troubleshooting.
✔ Team handling and leadership abilities.
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🌟 Why Join Syngene?
✔ Opportunity to work with a leading CRDMO.
✔ Exposure to global biologics and biopharmaceutical projects.
✔ Work on advanced analytical development programs.
✔ Career growth opportunities in biologics research.
✔ Innovation-driven and collaborative work culture.
✔ Opportunity to contribute to high-impact scientific projects.
✔ Strong focus on quality, safety, and professional development.
Candidates should highlight relevant experience in biologics analytics, method development, validation, and technology transfer.
🎯 Key Responsibilities
- ✓ Develop, qualify, implement, and transfer analytical methods from R&D to Quality Control and manufacturing teams.
- ✓ Perform analytical testing for upstream, downstream, formulation, QC, and production samples.
- ✓ Generate, analyze, interpret, and document scientific data as per quality requirements.
- ✓ Prepare analytical reports, technical summaries, and scientific documentation.
- ✓ Maintain records using Electronic Lab Notebooks (ELN) and Electronic Document Management Systems (EDMS).
- ✓ Support analytical method validation and technology transfer activities.
- ✓ Guide analytical teams and support development of junior scientists.
- ✓ Participate in quality investigations, CAPA activities, and compliance initiatives.
- ✓ Ensure laboratory operations follow GMP, 5S, and quality management systems.
- ✓ Manage laboratory inventory, consumables, and instrument maintenance activities.
- ✓ Collaborate with cross-functional teams to achieve project objectives.
💡 Required Qualifications & Skills
🚀 Career Guidance & Interview Insights
To help you succeed, we've compiled original preparation guides, resume keywords, and growth analytics for this category of role.
This Analytical SME – Biologics role is a chance to contribute directly to life sciences, patient care, or pharmaceutical advancements. You will work within strict compliance frameworks, ensure rigorous quality standards, and collaborate with technical or medical experts. It is a career path that blends scientific excellence with a deep sense of social purpose.
Healthcare and pharmaceutical professionals grow through specialized scientific experience. Entry-level starts as Lab Technician, Chemist, or Quality Associate, progressing to Senior QA/QC Analyst. Advancement leads to Lab Supervisor, Clinical Project Manager, and senior management roles like Quality Director, VP of Regulatory Affairs, or Chief Scientific Officer.
Expected Technical & Behavioral Questions:
- Q1: How do you ensure compliance with WHO/GMP guidelines during laboratory operations?
Answer Tip: Mention strict adherence to Standard Operating Procedures (SOPs), detailed batch records, regular equipment calibration, and sanitization cycles. - Q2: What steps do you take when a quality deviation is detected in a product batch?
Answer Tip: Outline immediate isolation of the batch, raising a deviation report, root cause analysis (RCA), and initiating CAPA (Corrective and Preventive Action). - Q3: How do you manage safety protocols while handling toxic chemicals?
Answer Tip: Discuss using Material Safety Data Sheets (MSDS), wearing appropriate Personal Protective Equipment (PPE), proper ventilation, and chemical spill kits.
To pass automated ATS (Applicant Tracking System) screening and catch the recruiter's eye, tailor your resume with the following tips:
- Keywords to include: Quality Control (QC), GMP Compliance, FDA Regulations, SOP Documentation, HPLC/GC analysis, Batch Validation, Clinical Trials, Pharmacovigilance.
- Format: List laboratory skills and instruments handled (e.g. HPLC, spectrophotometer) in a dedicated technical matrix.
- Quantify Results: E.g., 'Validated 15 batch formulations under GMP guidelines with zero quality defects.'
Estimated compensation for this role type in India is ₹2,40,000 - ₹3,80,000 per annum (Fresher analyst). The actual salary package offered depends on factors such as company size, work mode (remote or on-site), individual technical proficiency, and negotiations during final HR rounds.
Key credentials: GMP Certified Professional (ASQ), Certified Clinical Research Coordinator (CCRC), or specialized laboratory training certificates in high-performance liquid chromatography (HPLC) and safety standards.
Frequently Asked Questions
Q1. Who can apply for the Analytical SME – Biologics role?
Candidates with a Master’s degree in Biotechnology, Life Sciences, Chemical Engineering, or related fields with relevant biologics experience can apply.
Q2. What is the job location?
The position is based in Bangalore, Karnataka, India.
Q3. What experience is required for this position?
The role is for experienced professionals with expertise in biologics analytical development.
Q4. What techniques are important for this role?
Experience with Liquid Chromatography, Capillary Electrophoresis, impurity analysis, and analytical method development is preferred.
Q5. Is monoclonal antibody experience required?
Experience working with monoclonal antibodies (mAbs) and biologics products is preferred.
Q6. What department is hiring?
The opening is within Syngene’s Biopharmaceutical Development department.
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