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Clinical Research Scientist
2 months ago
Company Overview:
At PSG Global Solutions, we are dedicated to providing exceptional service and transforming the lives of the candidates we represent. We collaborate with leading pharmaceutical, biotechnology, and medical companies worldwide.
Role Overview:
We are seeking a Clinical Research Scientist who will provide scientific leadership and hands-on technical expertise in troubleshooting and conducting analytical research and development of pharmaceutical materials.
Key Responsibilities:
As a Clinical Research Scientist, your responsibilities will include, but are not limited to:
- Leading and guiding laboratory staff in method development and validation for the analysis of starting materials, intermediates, and finished products in compliance with cGMP regulations and established protocols.
- Conducting hands-on scientific research to understand the fundamentals of methods, materials, and products.
- Performing troubleshooting of methods and investigating product issues.
- Preparing scientific publications for submission to peer-reviewed journals.
- Ensuring compliance of all facilities, equipment, and daily activities with cGMP regulations and relevant guidelines.
- Developing, optimizing, and validating analytical methods.
- Investigating and resolving technical issues related to methods, materials, and products.
- Qualifying and transferring analytical methodologies to quality control or contract laboratories.
- Supporting drug product development and characterization of drug substances and impurities.
- Reviewing analytical data and assisting project team leaders in meeting deliverables.
- Maintaining significant hands-on involvement in laboratory activities.
- Preparing documentation and reports, and authoring manuscripts for publication.
Qualifications Required:
The ideal candidate will possess:
- A working knowledge of cGMP, FDA, and ICH guidelines.
- Familiarity with USP and other compendia.
- A comprehensive understanding of chemistry and pharmaceutical sciences.
- Strong problem-solving and troubleshooting skills.
- Extensive hands-on experience with LC-MS, HPLC, and dissolution testing.
- Excellent verbal and written communication skills, demonstrating teamwork and accountability.
- The ability to work independently with minimal supervision.
- A proven track record of scientific publications.
Specific Requirements:
Applicants should have:
- Hands-on experience in HPLC method development and validation, as well as impurity identification using LC-MS.
- A comprehensive understanding of developing dissolution methods for various solid oral dosage forms.
- A medical background with at least 5 years of experience focused on Hematology/Oncology.
- The capability to function independently in data cleaning.
We value relationships and knowledge sharing, ensuring our clients and candidates continue to collaborate with us repeatedly.
