Exela Pharma Sciences
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Research Scientist I
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Exela Pharma Sciences LLC Get AI-powered advice on this job and more exclusive features. Position Summary
The Research Scientist I, Analytical, will be responsible for validating methods for raw materials and drug products utilizing appropriate analytical techniques with some supervision. The incumbent will generate and review technical documents supporting development, including method validation protocols and reports. This position also involves providing analytical testing to support ongoing development, product release, raw material release, and stability studies as needed. Responsibilities include managing validation and transfer activities related to product development. The role supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and FDA regulatory requirements. Job Responsibilities Develop and validate methods for various analytical techniques with some supervision. Draft and review technical documents supporting development, such as method validation protocols and reports, and compatibility protocols and reports. Perform analytical testing as needed to support product development. Conduct analytical testing of samples supporting incoming raw materials, in-process production, finished products, and stability samples. Utilize analytical instrumentation such as FTIR, HPLC, GC, AA, wet chemistry techniques, UV/VIS, KF, and Polarimeter, with a scientific understanding of these techniques. Perform instrument and method troubleshooting as needed. Investigate studies with unusual results, out-of-trend, and out-of-specification results. Write, review, and update standard operating procedures and department policies as needed. Ensure all activities are in compliance with cGLP/cGMP requirements. Complete Resource Conservation and Recovery Act training within 6 months of hire and annually thereafter. Perform other duties as assigned.
Required Skills Excellent attention to detail and working knowledge of FDA Regulations/Guidance, Good Laboratory Practices, Good Manufacturing Practices, ICH Guidelines, USP/NF. Strong verbal and written communication skills, organization, time-management, sound judgment, problem-solving, interpersonal, and analytical skills.
Education And Experience Requirements
Bachelors degree in chemistry or a related scientific discipline with at least 2 years of relevant Analytical Chemistry experience, preferably in R&D or QC within the pharmaceutical industry. Knowledgeable on Empower software.
Additional Information
EOE, including disability/vets. Seniority level
Entry level
Employment type
Full-time
Job function
Other
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Exela Pharma Sciences LLC by 2x. Get notified about new Research Scientist jobs in
Lenoir, NC . #J-18808-Ljbffr
Research Scientist I
role at
Exela Pharma Sciences LLC Get AI-powered advice on this job and more exclusive features. Position Summary
The Research Scientist I, Analytical, will be responsible for validating methods for raw materials and drug products utilizing appropriate analytical techniques with some supervision. The incumbent will generate and review technical documents supporting development, including method validation protocols and reports. This position also involves providing analytical testing to support ongoing development, product release, raw material release, and stability studies as needed. Responsibilities include managing validation and transfer activities related to product development. The role supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and FDA regulatory requirements. Job Responsibilities Develop and validate methods for various analytical techniques with some supervision. Draft and review technical documents supporting development, such as method validation protocols and reports, and compatibility protocols and reports. Perform analytical testing as needed to support product development. Conduct analytical testing of samples supporting incoming raw materials, in-process production, finished products, and stability samples. Utilize analytical instrumentation such as FTIR, HPLC, GC, AA, wet chemistry techniques, UV/VIS, KF, and Polarimeter, with a scientific understanding of these techniques. Perform instrument and method troubleshooting as needed. Investigate studies with unusual results, out-of-trend, and out-of-specification results. Write, review, and update standard operating procedures and department policies as needed. Ensure all activities are in compliance with cGLP/cGMP requirements. Complete Resource Conservation and Recovery Act training within 6 months of hire and annually thereafter. Perform other duties as assigned.
Required Skills Excellent attention to detail and working knowledge of FDA Regulations/Guidance, Good Laboratory Practices, Good Manufacturing Practices, ICH Guidelines, USP/NF. Strong verbal and written communication skills, organization, time-management, sound judgment, problem-solving, interpersonal, and analytical skills.
Education And Experience Requirements
Bachelors degree in chemistry or a related scientific discipline with at least 2 years of relevant Analytical Chemistry experience, preferably in R&D or QC within the pharmaceutical industry. Knowledgeable on Empower software.
Additional Information
EOE, including disability/vets. Seniority level
Entry level
Employment type
Full-time
Job function
Other
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Exela Pharma Sciences LLC by 2x. Get notified about new Research Scientist jobs in
Lenoir, NC . #J-18808-Ljbffr