Senior Associate Research Scientist

Senior Associate Research Scientist

This Senior Associate Research Scientist role sits within a Bioanalytical and Analytical Operations team and focuses on supporting development and process characterization activities in a regulated laboratory environment. The position is ideal for a scientist who enjoys hands-on analytical testing, problem-solving, and generating high-quality data to advance research and development programs. You will work with a broad range of analytical techniques and instrumentation and collaborate closely with multidisciplinary teams to support critical development initiatives while maintaining strong data integrity and compliance with regulatory standards.

• Perform analytical testing and data analysis using established methods with minimal supervision.
• Execute a variety of laboratory assays, including Karl Fischer moisture analysis, coagulation assays, enzymatic assays, and immunoassays.
• Operate, troubleshoot, and maintain analytical laboratory instrumentation such as coulometric titrators, coagulation analyzers, immunonephelometers, and plate readers.
• Accurately document laboratory activities in laboratory notebooks, electronic systems, or LIMS platforms, ensuring complete and compliant records.
• Contribute to technical reports, data summaries, and project documentation that support development and process characterization activities.
• Investigate unexpected or out-of-specification results and participate in root cause analysis and problem-solving efforts.
• Follow laboratory procedures, GMP/GxP standards, and applicable regulatory requirements to ensure high-quality and compliant data generation.
• Collaborate effectively with team members across disciplines while maintaining strong attention to detail and data integrity.
• Support analytical method validation and CMC development activities as needed in alignment with regulatory expectations.
• Utilize computer systems, including Microsoft Office and electronic laboratory documentation tools, to manage data and communicate results.

• Bachelor's degree in Biology, Biochemistry, Chemistry, Toxicology, or a related scientific field with 3–4 years of relevant laboratory experience, OR a Master's degree in a relevant scientific field with 1+ year of relevant laboratory experience.
• Demonstrated experience performing analytical testing in a laboratory environment.
• Strong understanding of laboratory techniques, sample handling, and pipetting practices.
• Ability to execute assays such as Karl Fischer moisture analysis, coagulation assays, enzymatic assays, and immunoassays.
• Hands-on experience operating and maintaining analytical laboratory instrumentation, including coulometric titrators, coagulation analyzers, immunonephelometers, and plate readers.
• Excellent organizational skills with the ability to manage multiple experiments and tasks while meeting deadlines.
• Strong documentation skills and meticulous attention to detail in recording laboratory activities and data.
• Effective written and verbal communication skills for collaborating with multidisciplinary teams and contributing to technical reports.
• Proficiency with Microsoft Office applications for data analysis, reporting, and communication.
• Commitment to following laboratory procedures, GMP/GxP standards, and applicable regulatory requirements.

• Experience working in a GMP, GLP, GxP, or other regulated laboratory environment.
• Familiarity with analytical method validation and CMC development activities.
• Understanding of regulatory expectations related to analytical testing and documentation.
• Experience utilizing LIMS or other electronic laboratory documentation systems.
• Prior experience investigating analytical deviations, atypical results, or assay troubleshooting.
• Comfort working with bioanalytical and analytical operations teams in a collaborative environment.
• Strong problem-solving mindset and ability to participate in root cause analysis for unexpected results.

This is a laboratory-based role that requires onsite presence in RTP, NC. You will work in a regulated laboratory environment with frequent use of analytical instrumentation and computer systems. The position involves regular use of personal protective equipment, including safety glasses, gloves, and laboratory garments, in accordance with established safety procedures. You will perform repetitive hand movements and precise manipulation of laboratory tools and equipment, and you should be able to lift up to 35 pounds occasionally.

The role includes exposure to laboratory chemicals and biological materials, managed under strict safety protocols to ensure a safe and compliant work setting.

This is a Contract position based out of Durham, NC.

The pay range for this position is $35.00 - $35.00/hr individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job…