Associate Scientist

Associate Scientist

Kelly Science & Clinical is seeking an Associate Scientist near Concord, OH.

Direct Hire

Shift: Monday – Friday 8am-5pm

Compensation: $62,000- $75,000/year DOE + benefits

Essential Responsibilities

• Perform stability testing using techniques such as HPLC, GC, KF, XRD, DSC, TGA, and PSD within a cGMP-regulated laboratory.
• Coordinate the timely and compliant generation of stability data to support client projects.
• Author and review stability protocols, reports and related documentation.
• Conduct out of specification (OOS) investigations, identify potential root causes, and support implementation of corrective and preventative actions (CAPA).
• Review laboratory data for technical accuracy, completeness, and compliance with regulatory requirements.
• Manage laboratory inventory, stability chambers, and associated information systems.
• Collaborate with internal teams and clients to design appropriate batch release and stability studies for APIs and drug products.
• Develop and maintain knowledge of applicable ICH, FDA, EMA and GLP 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 analytical laboratory instrumentation (e.g., HPLC, analytical balances, pH meters, titrators, etc.)
• Familiarity with ICH stability guidelines preferred.
• Experience working in a cGMP compliant laboratory environment is preferred.
• Proficiency in laboratory techniques such as assay, impurity testing, sample preparations, dilutions, etc.
• Strong proficiency 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 written and verbal communication skills with the ability to interact effectively with clients and cross-functional teams.
• Proven ability to manage multiple priorities and work effectively in a fast-paced environment.