Quality Control Scientist

Role Summary:

We are seeking a highly motivated and experienced Analytical Scientist to join our newly formed GMP Stability Group. This role is critical in planning and executing stability studies for synthetic drug substances (DS) and drug products (DP) to support clinical development and regulatory filings. The successful candidate will perform high-quality QC testing, manage stability chambers, and generate comprehensive stability reports in accordance with ICH guidelines.

Key Responsibilities:

• Stability Planning and Execution: Set up and manage long-term, accelerated, and stressed stability studies for DS and DP of solid oral dosage forms, parenteral drugs, etc..
• Analytical Testing: Perform GMP stability testing using HPLC/UPLC (Assay/Degradation Products) (achiral and chiral), Dissolution, Karl Fischer, and other compendial methods.
• Data Processing and Reporting: Process and interpret data obtained from various analytical testings (listed above) with corresponding data/software system, compile and summarize analyzed data into well organized stability reports to enable project team meetings and regulatory submissions
• Compliance: Maintain strict adherence to GMP/GLP standards and department SOPs.

Required Qualifications:

• BS or MS in Analytical Chemistry, or a related scientific discipline.
• 3–5+ years of experience in a GMP laboratory environment specifically focused on pharmaceutical stability or QC testing.
• Knowledge of general wet laboratory practices, with extensive hands-on experience and a high degree of attention to details
• Knowledge of analytical chemistry best practices within GMP/GLP and R&D environment
• Strong expertise with HPLC/UPLC and LCMS, including operation, data handling, basic maintenance and troubleshooting
• Experience with Empower and quality systems (e.g., Veeva) is strongly preferred, familiarity with stability modeling software (e.g., ASAPprime) is a plus.
• Good written and documentation skills, especially with electronic notebooks, and oral communication skills
• Time management and project management skills
• Problem solving and troubleshooting abilities
• Ability to work in a collaborative work environment with a team