Catalent Pharma Solutions
Scientist, QC Analytical
Catalent Pharma Solutions, Harmans, Maryland, United States, 21077
The
Scientist, QC Analytical
is responsible for supporting analytical testing in order to support GMP manufacturing for both clinical and commercial clients. The Scientist, QC must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.Shift:
Monday-Friday 3pm-12amThe role:Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pHDocumenting testing per GMP/GDP proceduresGenerate internal and external documents such as assay protocols, summary reports, and SOPsAnalytical support to QC method services of method verification of platform test methodsSupports release and stability testing for raw materials, components, standards, intermediate/finished productsReviews laboratory work and approves data packages as designated by the SupervisorProvide instrumentation care, maintenance, troubleshooting, and data interpretationResponsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trendingThe candidate:Bachelor in a Life Sciences discipline with 2 – 4 years of experience working in a cGMP QC laboratory.Masters’ in a Life Sciences discipline with 0 – 2 years of experience working in a cGMP QC laboratory.Experience with any of the following techniques is preferred ELISA, qPCR, ddCPR, HPLC, CEKnowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biologyExperience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in QC function with a strong familiarity of general GMP practicesExperience in writing SOPsWhy you should join Catalent:Competitive medical benefits and 401K152 hours PTO + 8 Paid HolidaysDynamic, fast-paced work environmentOpportunity to work on Continuous Improvement ProcessesCatalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.Catalent is an Equal Opportunity Employer, including disability and veterans.
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Scientist, QC Analytical
is responsible for supporting analytical testing in order to support GMP manufacturing for both clinical and commercial clients. The Scientist, QC must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.Shift:
Monday-Friday 3pm-12amThe role:Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pHDocumenting testing per GMP/GDP proceduresGenerate internal and external documents such as assay protocols, summary reports, and SOPsAnalytical support to QC method services of method verification of platform test methodsSupports release and stability testing for raw materials, components, standards, intermediate/finished productsReviews laboratory work and approves data packages as designated by the SupervisorProvide instrumentation care, maintenance, troubleshooting, and data interpretationResponsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trendingThe candidate:Bachelor in a Life Sciences discipline with 2 – 4 years of experience working in a cGMP QC laboratory.Masters’ in a Life Sciences discipline with 0 – 2 years of experience working in a cGMP QC laboratory.Experience with any of the following techniques is preferred ELISA, qPCR, ddCPR, HPLC, CEKnowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biologyExperience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in QC function with a strong familiarity of general GMP practicesExperience in writing SOPsWhy you should join Catalent:Competitive medical benefits and 401K152 hours PTO + 8 Paid HolidaysDynamic, fast-paced work environmentOpportunity to work on Continuous Improvement ProcessesCatalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.Catalent is an Equal Opportunity Employer, including disability and veterans.
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