Job Title: Associate Scientist, Stability
Department: Stability
Position Summary
We are seeking a detail-oriented and proactive Associate Scientist to join our cGMP API Stability Laboratory. This role involves supporting analytical stability studies in compliance with regulatory guidelines. The ideal candidate will have hands-on experience with small molecule drug substances and drug product batch release and stability testing, and experience working in a cGMP environment.
Essential Responsibilities
- Conduct stability testing (e.g., HPLC, KF, XRD, DSC, TGA) and support activities in a cGMP-regulated laboratory.
- Coordinate the timely and compliant generation of stability data to support client projects.
- Author and review stability protocols and reports.
- Perform out of specification (OOS) investigations, identify potential root causes, and support implementation of corrective actions.
- Review laboratory data for technical accuracy and regulatory compliance.
- Manage laboratory inventory, environmental chambers, and related information systems.
- Collaborate with clients to design appropriate batch release and stability studies for APIs and drug products.
- Develop and maintain expertise with applicable ICH, FDA, and EMEA stability guidelines.
Qualifications
Education and Experience:
- Bachelor's degree in chemistry or a related scientific discipline required.
- Minimum of 2 + years of relevant analytical laboratory experience in a cGMP environment, or an equivalent combination of education and experience.
- Relevant experience in a quality control or stability laboratory is essential.
Skills and Competencies
- Hands-on experience with standard laboratory instruments (e.g., HPLC, analytical balances, pH meters, titrators,etc.)
- Familiarity with ICH stability guidelines preferred.
- Experience working in a GMP compliant laboratory setting is preferred.
- Proficient in laboratory techniques such as assay, impurities testing, sample preparations, dilution, etc.
- Strong skills in Microsoft Word and Excel
- Experience with OOS investigations and root cause analysis is preferred.
- Solid understanding of arithmetic, algebra, and basic statistical concepts.
- Strong communication skills with the ability to interact effectively with clients and internal teams.
- Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
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