Biopharma Analyst

Job Title: Biopharma Analyst

Job Location: Bangalore, Biocon Park

Department: Quality Control -Biologics

 About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Description:

• 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.

Key Responsibilities:  

• Managing the Inprocess/Finished product/Stability by adhering to compliance norms.
• Handling of Quality management system documents
• Ensuring all time audit readiness.
• Guidance to the analysts on good laboratory and analytical procedures.

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.

Behavioral Skills:

• Aggressive but assertive on task completion.
• High influencing skills to complete the task at hand.
• Ability to provide solutions for complex problems.

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 accommodation for qualified individuals with disabilities.