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/RTPCR bioassays ELISA residuals compendial tests and other largemolecule 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 rootcause 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 largemolecule characterization and release/stability testing
• Deep understanding of biologics testing and method lifecycle management.
• Proven experience in team management and GMPregulated environments.
• Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
• Ability to handle multiple projects meet timelines and manage client expectations.
• Strong problemsolving 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 addition Syngene will provide reasonable accommodation for qualified individuals with disabilities.