Research and Product Development Scientist

Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Position: Research and Development Scientist

Location: Cincinnati,OH 45237

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: Monday To Friday From 08:00 AM To 05:00 PM
Summary:
We are seeking an R&D / Manufacturing Scientist II to support pharmaceutical development and manufacturing activities through analytical testing, method development and validation, data review, and laboratory troubleshooting. The ideal candidate will have hands-on pharmaceutical laboratory experience and a strong understanding of GMP and regulatory requirements. This role will contribute to high-quality analytical work and support successful delivery of project objectives within the Cincinnati Pharmaceutical Services Group.
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 analytical method validation protocols in accordance with regulatory requirements and approved laboratory procedures.
Process, review, interpret, document, and report analytical data.
Communicate analytical results clearly to internal teams and external clients and provide data-based recommendations.
Maintain and troubleshoot analytical instrumentation.
Support implementation of new analytical methods and laboratory processes.
Manage assigned project tasks with minimal supervision and ensure deliverables are completed on time.
Identify and communicate project next steps, issues, and potential solutions.
Perform all work in compliance with SOPs, GMPs, GLPs, and applicable safety requirements.
Follow appropriate laboratory safety procedures and PPE requirements when working with hazardous or toxic materials.
Required Skills:

• Bachelor's degree in Chemistry, Biochemistry, or another technical/scientific field, or equivalent combination of education and experience.
• 2-3 years of pharmaceutical GMP laboratory and regulatory experience.
• Pharmaceutical industry experience required.
• Hands-on experience performing chemical testing using chromatographic, spectroscopic, dissolution, or other analytical techniques.
• HPLC/UPLC experience, including assay and related substances testing.
• GC and GCHS experience, including chromatographic troubleshooting.
• Dissolution testing, Oral Solid Dosage (OSD), and ARS experience required.
• Analytical method development and method validation experience.
• Experience with method validation parameters including repeatability, intermediate precision, filter studies, linearity, accuracy, and solution stability.
• Working knowledge of chemistry, analytical instrumentation, and pharmaceutical quality/regulatory requirements.
• Experience working in compliance with GMP, GLP, SOPs, and laboratory safety requirements.
• Strong written and verbal communication skills.
• Strong organizational, analytical, problem-solving, and troubleshooting skills.
• Ability to manage assigned projects and tasks with minimal supervision.
• Ability to work effectively with internal teams and external clients.
• Customer-focused approach with a commitment to quality, timely delivery, and continuous improvement.
• Empower experience preferred.
• Ability to stand, walk, stoop, and kneel as needed and lift up to 40 lbs. without assistance.
• Ability to work with hazardous or toxic materials and wear required PPE, including safety glasses, gowning, gloves, lab coat, and hearing protection as applicable.