Scientist II

8:00 AM-5:00 PM, Monday-Friday

Start time can be flexible after training. between 6am to 9am start.




Position Summary:
Support pharmaceutical development and manufacturing through analytical testing, method development and validation, data review, and laboratory troubleshooting. The role contributes to high-quality, compliant analytical work and effective delivery of project objectives within the Cincinnati Pharmaceutical Services Group.




Key Responsibilities:
Perform routine chemical and physical testing of pharmaceutical finished products and stability samples using chromatographic, spectroscopic, dissolution, and other analytical techniques.
Develop analytical methods and participate in validation of methods for pharmaceutical raw materials and finished products.
Write and execute validation protocols in accordance with regulatory requirements and approved laboratory procedures.
Process, review, interpret, document, and report analytical data; communicate results clearly to internal teams and external clients and make data-based recommendations.
Maintain and troubleshoot analytical instrumentation and support implementation of new methods and processes.
Manage assigned project tasks with minimal supervision, ensuring deliverables are completed and next steps are clearly identified.
Perform all work in compliance with SOPs, GMPs, GLPs, and applicable safety requirements.




Qualifications:
Bachelor's degree in Chemistry, Biochemistry, or another technical/scientific field or equivalent with 2-3 years of GMP and regulatory experience.
Experience performing chemical testing using chromatographic, spectroscopic, or other analytical techniques.
Pharmaceutical industry experience required.




Technical Skills
HPLC/UPLC, including assay and related substances required. Empower experience preferred.
GC and GCHS; chromatographic troubleshooting.
Dissolution testing; oral solid dosage (OSD) and ARS experience required.
Method validation, including repeatability, intermediate precision, filter studies, linearity, accuracy, and solution stability.
Working knowledge of chemistry, analytical instrumentation, and pharmaceutical quality/regulatory requirements.




Core Competencies
Strong written and verbal communication and interpersonal skills.
Organized, diligent, and effective at problem-solving.
Customer-focused with a commitment to quality, timely delivery, and continuous improvement.
Proactively identifies ideas and solutions that strengthen team and site performance.




Physical & Work Environment Requirements:
Ability to stand, walk, stoop, and kneel as needed and lift up to 40 lbs. without assistance. Work may involve hazardous/toxic materials and requires adherence to GMP safety standards and use of appropriate PPE, including safety glasses, gowning, gloves, lab coat, and hearing protection as applicable. Adequate vision is required for computer and laboratory equipment use.