Analytical Chemist
Job Summary
The Analytical Chemist will be responsible for analytical method development, validation, and troubleshooting for starting materials and finished products. The role involves ensuring compliance with regulatory requirements and pharmacopeia standards. Additionally, the position requires training lab personnel and conducting various impurity and risk assessment studies.
Responsibilities
- Develop and validate analytical methods
- Perform OOS/OOT investigations and reporting
- Conduct risk assessments (nitrosamine, elemental impurity)
- Train lab staff and support method transfer to QC
- Ensure regulatory and pharmacopeia compliance
Required Skills
- Analytical method development & validation
- Pharmacopeia & regulatory guidelines knowledge
- Laboratory equipment troubleshooting
- Data analysis and interpretation
- Drug formulation knowledge
Job Details
Responsibilities:
- Report to the R&D Manager on matters related to analytical method development, improvement, and troubleshooting.
- Execute analytical method development and validation in compliance with regulatory requirements and pharmacopeia.
- Review DMFs, establish finished product and starting material test procedures, specifications, and COAs.
- Train other chemists and lab technicians on method validation and development activities.
- Prepare analytical reports, including development reports, validation protocols, and investigation reports.
- Participate in laboratory investigations, out-of-specification (OOS), and out-of-trend (OOT) investigations.
- Prepare responses to analytical-related regulatory queries.
- Conduct extractable and leachable studies, nitrosamine risk assessments, and elemental impurity risk assessments.
- Assist the Validation Team in process validation and cleaning qualification.
- Execute method transfer from R&D to QC.
- Troubleshoot laboratory equipment failures and provide improvement proposals.
- Achieve R&D department KPIs and comply with quality, health, safety, and environment policies.
Requirements:
- Bachelor Degree, Master or PhD in Pharmaceutical, Chemistry, Biochemistry or any science related course.
- Minimum 3 years hands-on working experience in analytical method development, validation, and testing.
- Strong ability to conduct experiments, analyse data, and interpret results accurately.
- In-depth understanding of analytical method development, method validation, drug formulation, analytical testing, pharmacopeias, and regulatory guidelines.