Catalent Pharma Solutions
Lead Scientist, QC Analytical
Catalent Pharma Solutions, Harmans, Maryland, United States, 21077
Catalent Pharma Solutions Lead Scientist, QC Analytical Harmans, Maryland Apply Now
The
Lead Scientist, QC
is responsible for leading analytical testing, investigations, and key deliverables for the Quality Control (QC) group. The Lead Scientist, QC must demonstrate expert technical knowledge, trains new scientists on basic scientific/regulatory principles, possess initiative, and maintains a strong commitment to scientific excellence as well as a strong cGMP understanding and mindset to help drive compliance within the department.Shift:
Friday-Monday 7am-6pmThe role:Maintains weekly schedule of incoming testing and balances priorities from routine manufacturing samples, stability samples, and method transfer activities.Teaches others regarding his/her expertise, mentors and trains other members of the QC group in regards to day-to-day lab activities and team goals.Actively participates in training activities, managing individual training plan.Apply basic scientific and regulatory principles to solve operations, as well as routine tasks, in the QC department.Generate internal and external documents such as assay protocols, summary reports, client comment responses, and SOPs.Supports release and stability testing for raw materials, components, standards, intermediate/finished products.Perform assays such as ELISA, DNA/RNA extraction, gel electrophoresis, qPCR, ddPCR, HPLC, and Capillary Electrophoresis.Responsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.The candidate:Bachelor in a Life Sciences discipline with 6 – 8 years of experience working in a cGMP QC laboratory.Masters’ in a Life Sciences discipline with 4 – 6 years of experience working in a cGMP QC laboratory.Ph.D. in a Life Sciences discipline with 2 – 4 years of experience working in a cGMP QC laboratory.Experience with ELISA, ddPCR, qPCR, Empower 3 preferred but not required.Knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology.Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in QC function with a strong familiarity of general GMP practices.Experience in writing SOPs.Why you should join Catalent:Competitive medical benefits and 401K.152 hours PTO + 8 Paid Holidays.Dynamic, fast-paced work environment.Opportunity to work on Continuous Improvement Processes.Catalent 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 is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.Catalent is an Equal Opportunity Employer, including disability and veterans.
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The
Lead Scientist, QC
is responsible for leading analytical testing, investigations, and key deliverables for the Quality Control (QC) group. The Lead Scientist, QC must demonstrate expert technical knowledge, trains new scientists on basic scientific/regulatory principles, possess initiative, and maintains a strong commitment to scientific excellence as well as a strong cGMP understanding and mindset to help drive compliance within the department.Shift:
Friday-Monday 7am-6pmThe role:Maintains weekly schedule of incoming testing and balances priorities from routine manufacturing samples, stability samples, and method transfer activities.Teaches others regarding his/her expertise, mentors and trains other members of the QC group in regards to day-to-day lab activities and team goals.Actively participates in training activities, managing individual training plan.Apply basic scientific and regulatory principles to solve operations, as well as routine tasks, in the QC department.Generate internal and external documents such as assay protocols, summary reports, client comment responses, and SOPs.Supports release and stability testing for raw materials, components, standards, intermediate/finished products.Perform assays such as ELISA, DNA/RNA extraction, gel electrophoresis, qPCR, ddPCR, HPLC, and Capillary Electrophoresis.Responsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.The candidate:Bachelor in a Life Sciences discipline with 6 – 8 years of experience working in a cGMP QC laboratory.Masters’ in a Life Sciences discipline with 4 – 6 years of experience working in a cGMP QC laboratory.Ph.D. in a Life Sciences discipline with 2 – 4 years of experience working in a cGMP QC laboratory.Experience with ELISA, ddPCR, qPCR, Empower 3 preferred but not required.Knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology.Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in QC function with a strong familiarity of general GMP practices.Experience in writing SOPs.Why you should join Catalent:Competitive medical benefits and 401K.152 hours PTO + 8 Paid Holidays.Dynamic, fast-paced work environment.Opportunity to work on Continuous Improvement Processes.Catalent 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 is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.Catalent is an Equal Opportunity Employer, including disability and veterans.
#J-18808-Ljbffr