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:
+ Bachelors 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.
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:
+ Bachelors 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.
Job ID: 482000849
Originally Posted on: 6/19/2025
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