• Associate Scientist

    Astrix Technology (Euclid, OH)


    Associate Scientist

     

    Clinical Project Manager/Scientist

     

    Euclid, OH, US

    Pay Rate Low: 65000 | Pay Rate High: 75000

    + Added - 05/05/2025

     

    Apply for Job

     

    Pay Range: $65,000-$75,000

    Position Summary

    We are looking for a detail-oriented and proactive Associate Scientist to join our Stability Laboratory. In this role, you will support analytical stability studies in accordance with regulatory guidelines. The ideal candidate will have hands-on experience with small molecule drug substances and drug product batch release and stability testing, along with a strong background working in a cGMP-compliant environment.

    Key Responsibilities

    + Perform stability testing and related tasks in a cGMP-compliant laboratory environment.

    + Ensure timely and compliant generation of stability data to support client programs.

    + Draft and review stability study protocols and final reports.

    + Investigate out-of-specification (OOS) results, determine root causes, and support corrective action implementation.

    + Evaluate laboratory data for technical accuracy and adherence to regulatory standards.

    + Oversee laboratory inventory, manage environmental chambers, and maintain supporting information systems.

    + Partner with clients to design suitable batch release and stability testing strategies for APIs and finished drug products.

    + Stay current with relevant ICH, FDA, and EMEA guidelines for stability studies.

    Qualifications

    Education and Experience:

    + A Bachelor’s degree in Chemistry or a closely related scientific field is required.

    + A minimum of 2 years of hands-on experience in an analytical laboratory within a cGMP-regulated environment, or an equivalent combination of education and experience.

    + Direct experience in a quality control or stability testing laboratory is strongly preferred.

    Skills and Competencies

    + Hands-on experience with standard laboratory instruments, including HPLC, analytical balances, pH meters, and more.

    + Proficient in essential laboratory techniques such as assay performance, impurity testing, sample preparation, and dilutions.

    + Familiar with ICH stability guidelines and their application in pharmaceutical testing.

    + Experience working in GMP-compliant laboratory environments, ensuring adherence to regulatory standards and quality protocols. **_This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you_** _INDBH_

     

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.