PSG Global Solutions
Scientist, Clinical Research
PSG Global Solutions, Summit, New Jersey, us, 07902
At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the world's best pharmaceutical, biotechnology and medical companies.As specialists in recognising talent we pride ourselves on not just finding the best people for our client partners but on our ability to spot the best and brightest talent to work for us. We are also renowned for providing training and long-term career opportunities to help our employees be the best they can be, so they can continue to deliver the expertise Real has become famous for.Relationships are at the heart of everything we do and ensure that our clients and candidates continue to work with us again and again. This ethos is also what shapes how we work as a business. We encourage and reward knowledge sharing and have various support networks and international forums to enable our employees to keep up-to-date with changes happening across their industries and share local insight to deliver true global perspectives.Job Description
Provide scientific leadership and hands on technical expertise in trouble shooting and conducting analytical research and development of pharmaceutical materials under minimal guidance and oversight from his/her supervisor.Responsibilities will include, but are not limited to, the following:Provide scientific leadership and guidance to laboratory staff in method development and validation for the analysis of starting materials, intermediates, and finished products in accordance with cGMP regulations, established protocols, and all applicable SOPs.Conduct hands on scientific research to understand the fundamentals of the methods, materials and the products.Perform hands on trouble shooting of methods and investigation of products.Prepare scientific publications for submission to peer reviewed journals.Ensure that all facilities, equipment, and daily activities are and remain in compliance with cGMP regulations, relevant regulatory guidelines and appropriate SOPs.Develop, optimize and validate analytical methods.Investigate and trouble shoot any technical issues with methods, materials, and products.Qualify/transfer analytical methodology to quality control or contract laboratories.Support drug product development and characterization of drug substances and impurities.Review analytical data.Assist analytical project team leader to meet CMCDT deliverables.Require significant hands-on involvement in the laboratory.Prepare documents and reports.Author and co-author manuscripts for publication.Qualifications
Required:Working knowledge of cGMP, FDA and ICH guidelines.Familiar with USP, and other compendia.A comprehensive knowledge in chemistry and pharmaceutical sciences.Strong problem-solving and troubleshooting skills.Extensive hands-on experience and knowledge with LC-MS, HPLC and Dissolution testing.Strong verbal/written communication and interpersonal skills as a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional integrity are required.Ability to work independently with minimal supervision.Demonstrated track record of scientific publications.Specific Requirements:Must have knowledge and hands-on experience in
HPLC
method development and validation and impurity identification using
LC-MS .Comprehensive knowledge in developing dissolution methods for various solid oral dosage forms is a plus.Medical background.At least 5 years’ experience focused on Hematology/Oncology.Must be able to function independently in data cleaning (data analysis experience not needed).
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Provide scientific leadership and hands on technical expertise in trouble shooting and conducting analytical research and development of pharmaceutical materials under minimal guidance and oversight from his/her supervisor.Responsibilities will include, but are not limited to, the following:Provide scientific leadership and guidance to laboratory staff in method development and validation for the analysis of starting materials, intermediates, and finished products in accordance with cGMP regulations, established protocols, and all applicable SOPs.Conduct hands on scientific research to understand the fundamentals of the methods, materials and the products.Perform hands on trouble shooting of methods and investigation of products.Prepare scientific publications for submission to peer reviewed journals.Ensure that all facilities, equipment, and daily activities are and remain in compliance with cGMP regulations, relevant regulatory guidelines and appropriate SOPs.Develop, optimize and validate analytical methods.Investigate and trouble shoot any technical issues with methods, materials, and products.Qualify/transfer analytical methodology to quality control or contract laboratories.Support drug product development and characterization of drug substances and impurities.Review analytical data.Assist analytical project team leader to meet CMCDT deliverables.Require significant hands-on involvement in the laboratory.Prepare documents and reports.Author and co-author manuscripts for publication.Qualifications
Required:Working knowledge of cGMP, FDA and ICH guidelines.Familiar with USP, and other compendia.A comprehensive knowledge in chemistry and pharmaceutical sciences.Strong problem-solving and troubleshooting skills.Extensive hands-on experience and knowledge with LC-MS, HPLC and Dissolution testing.Strong verbal/written communication and interpersonal skills as a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional integrity are required.Ability to work independently with minimal supervision.Demonstrated track record of scientific publications.Specific Requirements:Must have knowledge and hands-on experience in
HPLC
method development and validation and impurity identification using
LC-MS .Comprehensive knowledge in developing dissolution methods for various solid oral dosage forms is a plus.Medical background.At least 5 years’ experience focused on Hematology/Oncology.Must be able to function independently in data cleaning (data analysis experience not needed).
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