QC Jobs | Syngene is Hiring | Apply Now
Want to work with one of India’s leading contract research and manufacturing organizations? A new Syngene Career opportunity is now available for experienced biotechnology professionals seeking QC Jobs in the biologics sector. The Biopharma Analyst position offers exposure to advanced biologics testing, quality management systems, regulatory compliance, method validation, and team leadership within a GMP-regulated environment. This Biotechnology Jobs opening can be an excellent career move for candidates interested in pharmaceutical and biopharmaceutical quality control.
- Job Title: Biopharma Analyst
- Location: Bangalore, Biocon Park
- Department: Quality Control – Biologics
About the Company
Syngene International is an innovation-focused global discovery, development, and manufacturing organization established in 1993. The company provides integrated scientific services to pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Syngene serves leading global organizations and is recognized for its strong scientific expertise, research capabilities, and commitment to innovation-driven solutions.
Key Responsibilities
- Lead and oversee daily QC laboratory operations for biologics (proteins, mAbs, RNA, ADC, etc.).
- Manage a team of analysts and leads, ensuring productivity, training, and performance excellence.
- Review and approve analytical results, CoAs, test records, and QC documentation.
- Oversee method qualification/validation, method transfer, and routine testing for assays such as: HPLC/UPLC, CE, SoloVPE, PCR/RT-PCR, bioassays, ELISA, residuals, compendial tests, and other large‑molecule techniques.
- Ensure adherence to ICH, pharmacopeial, and regulatory guidelines.
- To handle the associated Quality management system documents such as investigation of OOS/Deviations/Incidents etc.
- Review/approve SOPs/IOPs, protocols, reports, deviations, CAPAs, OOS/OOT investigations.
- Ensure timely closure of quality records with thorough root‑cause analysis.
- Partner closely with QA, Manufacturing, MSAT, RA, and Project Management teams.
- Provide QC inputs for new project onboarding, technical discussions, client updates, and regulatory queries
- Handling Internal audits, Client audits and Regulatory Audits pertaining to Biologics Operations Unit.
- Ensuring all time audit readiness and preparation prior to audits.
Educational Qualification
Master of Science / Master of Technology – Biotechnology / Bioprocess Engineering
Technical/functional Skills:
- Strong expertise in analytical techniques used for large‑molecule characterization and release/stability testing
- Deep understanding of biologics testing and method lifecycle management.
- Proven experience in team management and GMP‑regulated environments.
- Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
- Ability to handle multiple projects, meet timelines, and manage client expectations.
- Strong problem‑solving skills and ability to drive investigations and CAPA effectiveness.
This Syngene Career opportunity is an excellent option for professionals seeking Biotechnology Jobs and QC Jobs in the rapidly growing biologics sector. With exposure to advanced analytical techniques, regulatory compliance, biologics testing, and quality management systems, the Biopharma Analyst role offers strong career growth prospects in pharmaceutical and biotechnology industries. Interested candidates are encouraged to apply at the earliest opportunity.
