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Clinical Research Scientist
2 months ago
Overview:
At PSG Global Solutions, we are dedicated to delivering outstanding service levels and transforming the lives of the candidates we represent. We collaborate with some of the leading pharmaceutical, biotechnology, and medical organizations worldwide.
Our Commitment:
As experts in identifying talent, we take pride in not only sourcing the best candidates for our partners but also in recognizing exceptional talent to join our team. We are known for offering training and long-term career opportunities, empowering our employees to excel and maintain the expertise that PSG Global Solutions is recognized for.
Core Values:
Relationships are fundamental to our operations, ensuring that both clients and candidates choose to work with us repeatedly. This principle shapes our business practices.
Knowledge Sharing:
We promote and reward knowledge sharing, providing various support networks and international forums that allow our employees to stay informed about industry changes and share local insights for a truly global perspective.
Job Responsibilities:
As a Clinical Research Scientist, you will:
- Provide scientific leadership and hands-on technical expertise in troubleshooting and conducting analytical research and development of pharmaceutical materials.
- Guide 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.
- Conduct in-depth scientific research to understand the fundamentals of methods, materials, and products.
- Perform troubleshooting of methods and product investigations.
- Prepare scientific publications for submission to peer-reviewed journals.
- Ensure compliance of facilities, equipment, and daily activities with cGMP regulations and relevant guidelines.
- Develop, optimize, and validate analytical methods.
- Investigate and resolve technical issues related to methods, materials, and products.
- Support drug product development and characterization of drug substances and impurities.
- Review analytical data and assist project leaders in meeting deliverables.
- Prepare documentation and reports, including authoring manuscripts for publication.
Qualifications Required:
The ideal candidate will possess:
- 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 professional integrity.
- 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.
- Comprehensive knowledge in developing dissolution methods for various solid oral dosage forms.
- A medical background.
- A minimum of 5 years of experience focused on Hematology/Oncology.
- The ability to function independently in data cleaning.
