• Associate Scientist 2

    Olon Ricerca Bioscience LLC (OH)


    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.