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Validation Chemist
1 day ago
BioPharma Service - _Leading the way in early stage clinical research through Performance, Quality & Innovation_
**Position Summary**:
We are currently seeking a **Validation Chemist** to join our Bioanalytical Laboratory team. Reporting to the Bioanalytical Study Manager, the Validation Chemist will be responsible for executing method validation tasks to ensure validated bioanalytical methods are compliant with applicable SOPs and global regulatory requirements. This role requires strong analytical skills, technical knowledge of LC-MS/MS, and a proactive approach to problem-solving in a fast-paced, team-oriented environment.
**Key Responsibilities**:
- Conduct method validation analyses according to approved protocols and SOPs.
- Assist in study sample analysis as needed based on business priorities.
- Operate and maintain a range of laboratory equipment including LC-MS/MS and sample preparation systems.
- Produce high-quality analytical data, reports, and method documentation for regulatory submission.
- Support troubleshooting, calibration, and maintenance of lab instrumentation.
- Plan and coordinate project activities, adapting to changing priorities while meeting deadlines.
- Collaborate effectively with laboratory and project management teams to achieve study objectives.
- Ensure all work aligns with GLP (OECD), EMA, ICH, FDA, and TPD regulatory requirements.
- Review and contribute to SOP development and continuous improvement initiatives.
- Maintain organized records and compile/secure validation and study data.
- Follow and promote all safety and quality procedures in the lab.
**Additional GLP/Non-GLP Responsibilities**:
- Generate and document analytical results per study protocols and regulatory standards.
- Promptly report deviations to the Principal Investigator (GLP) or Study Director (non-GLP).
- Record raw data accurately and in compliance with OECD GLP principles.
- Notify management of any personal health conditions that may affect study integrity.
**Qualifications**:
- B.Sc. or College Diploma in Analytical Chemistry or a related field.
- 1-3 years of experience in a laboratory setting performing bioanalytical method validation.
- Hands-on experience with LC-MS/MS and other bioanalytical instruments preferred.
- Strong written and verbal communication skills.
- Demonstrated ability to work independently and within a team environment.
- High attention to detail and a commitment to quality and regulatory compliance.
**Why Join Us?**
At Biopharma Services, we are passionate about advancing science through integrity, performance, and innovation. Become part of a collaborative and quality-driven organization making a difference in early stage clinical research.
