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.

Olon Ricerca Bioscience LLC

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