- Perform the bioanalytical work including sample processing for method development, method validation and study sample analysis as per the protocol in compliance with SOPs, STPs.
- Prepare STP, MV protocol and study sample analysis protocol.
- Coordinate with maintenance department for any problems related to utilities and equipment / instrument (e.g. LC-MS/MS, HPLC, etc) failures.
- Document data generated, entries in official documents.
- Ensure all studies adhere to regulatory guidelines and expectations set by GCP/ GLP.
- Participate in all discussions on project-specific scientific details .
Education and Experience
Education
Masters in Pharmaceutics or other related life sciences from a reputed university.
Industry Experience
- Minimum of 1 years of experience in regulated small molecule bioanalysis
- Hands-on experience in small molecule regulated bioanalytical experiments
People leadership experience
NA
Exposure and experience
Experience with working for a Bioanalytical CRO lab will be an added advantage.
Core competencies required for the role
- Scientific:
- Brings a creative and an innovative advantage to projects
- Is curious, eager to learn and make a difference
- Thinks scientifically and understands the problem statement in assigned programs/assays
- Publishes posters, papers and articles regularly
- Technical
- Conducts/plans experiments without errors and gaps
- Reports/analyzes data punctually and communicates effectively
- Troubleshoots and investigates logically (is able to defend the logic behind experimental results)
- Is able to forecast risks and make mitigation plans ahead of time
- Has good organizational, project management skills
- Documentation
- Records data as per ALCOA++ policy
- Pays attention to detail
- Is punctual in responding to QC and QA reports
- Displays minimal audit finding index
- Writes clearly and concisely with English skills at >B+
Employment Type: Full Time, Permanent
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