Associate Scientist 2

Olon USA; Concord (OH); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is looking for a detail-oriented Associate Scientist to join their cGMP API Stability Laboratory. In this exciting role, you will conduct stability testing and support analytical studies while ensuring compliance with regulatory guidelines. The ideal candidate will have hands-on experience with small molecule drug substances and drug product stability testing. This position offers an excellent opportunity to grow your expertise in a collaborative environment, contributing to impactful projects in the pharmaceutical manufacturing sector. If you are passionate about science and thrive in a fast-paced setting, this role is perfect for you.

Qualifications

• 2+ years of relevant analytical lab experience in a cGMP environment.
• Experience with stability testing and quality control in pharmaceuticals.

Responsibilities

• Conduct stability testing and support activities in a cGMP-regulated lab.
• Author and review stability protocols and reports.

Skills

HPLC

Analytical Balances

pH Meters

Titrators

Sample Preparations

Root Cause Analysis

Microsoft Word

Microsoft Excel

Education

Bachelor's degree in Chemistry

Tools

Laboratory Instruments

Job description

Join to apply for the Associate Scientist 2 role at Olon USA

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:

1. Conduct stability testing (e.g., HPLC, KF, XRD, DSC, TGA) and support activities in a cGMP-regulated laboratory.
2. Coordinate the timely and compliant generation of stability data to support client projects.
3. Author and review stability protocols and reports.
4. Perform out of specification (OOS) investigations, identify potential root causes, and support implementation of corrective actions.
5. Review laboratory data for technical accuracy and regulatory compliance.
6. Manage laboratory inventory, environmental chambers, and related information systems.
7. Collaborate with clients to design appropriate batch release and stability studies for APIs and drug products.
8. Develop and maintain expertise with applicable ICH, FDA, and EMEA stability guidelines.

Qualifications:

• 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.

Additional Details:

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Research, Analyst, and Information Technology
• Industry: Pharmaceutical Manufacturing

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