Lead Research Scientist - Bioanalytical Analysis Support

Apotex; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Apotex in Bengaluru, India seeks a seasoned Bioanalytical Scientist to develop and validate analytical methods for drugs and metabolites in biological fluids under GLP and regulatory guidelines. You will collaborate with project leads on method development, validation, and routine sample analysis, while documenting results and preparing reports.

The role requires 7–9 years in bioanalytical sciences, with a strong emphasis on GLP, data integrity, and teamwork.

Qualifications

• Bachelor degree in Pharmacy or MSc required.
• GLP knowledge required.
• Proficient in MS Office and communication.
• Willing to work flexibly.
• 7-9 years in Bioanalytical field.

Responsibilities

• Develops and validates bio-analytical methods for quantitation of drugs and metabolites in biological fluids.
• Follows SOPs and regulatory guidelines (DCGI- CDSCO, USFDA, ICH, GLP).
• Works with project lead for method development, validation and RBSA.
• Documents work and reports results; prepares bioanalytical reports.
• Performs data verification in chromatography data systems and creates sample sequences in LIMS.
• Performs incurred sample reanalysis (ISR) selection when required.
• Involves in laboratory investigations and LIR preparation as needed.
• Sets up and calibrates analytical systems and maintains instruments.
• Demonstrates teamwork and adheres to safety and compliance policies.

Skills

GLP knowledge

MS Office

Communication skills

Flexibility

Team collaboration

Education

Bachelor in Pharmacy

Masters in Science

Job description

Job Summary

Under supervision of reporting manager responsible for developing, validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for the analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques. Responsible for interpreting data and completing the required reports and documentation

Job Responsibilities

• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre s, Standard Operating Procedures and in a consistent manner with current regulatory ( DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations.
• To work with the assigned project lead for Bioanalytical method development, Bioanalyitcal Method validation and Routine batch sample analysis (RBSA).
• Involves in preparation of project specific solutions and sample preparation.
• Documents all the work and results of all assignments as required.
• Verifies and saves acquired results in Chromatography Data acquisition systems.
• Creates sample sequences in Watson LIMS.
• Performs Incurred sample reanalysis (ISR) selection, when required.
• Performs Laboratory Investigation, and as required involves in Laboratory Investigation Report (LIR) preparation.
• Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems.
• Assists in the preparation of Bioanalytical reports.
• Performs raw data compilation, assists in project wrap-up and archiving after completion of final reports.
• Involves in troubleshooting of analytical instruments, and addresses procedural concerns, if necessary in consultation with reporting Manager
• Sets-up and ensures calibration of analytical systems and maintains instrument systems in good working order.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Minimum Bachelor Degree holder in Pharmacy or Masters Degree in Science.
• Knowledge, Skills and Abilities
  • Good knowledge of GLP requirements.
  • Good skills in MS Office.
  • Good in Communication skills.
  • Flexible to work
  • Strives to drive projects related to Bioanalytical effectively.
• Experience
  • Minimum 7-9 years of experience in Bioanalytical.