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Analytical Scientist (Drug Development)

Company: Comrise
Location: Hackettstown
Posted on: February 25, 2021

Job Description:

CONTRACT TO HIRE?Job SummaryThe Analytical Scientist will be part of a team of drug development professionals responsible for the continued development and regulatory approval of thin film drug products containing a wide range of therapeutic compounds.Job Responsibilities* Hands-on laboratory analysis of R&D drug substance and drug product samples.* Method development, method transfer and validation of analytical methods developed in-house or from client.* Provide analytical support during pre-formulation, formulation development and manufacture of prototype formulations, clinical trial materials and process scale-up.* Perform characterization, release and stability testing of raw material and drug product samples for conformance to specifications.* Prepare and update/review SOPs for the analytical laboratory.* Observe and maintain compliance with applicable DEA and safety regulations, cGLP/GMP guidelines, and policies and procedures.* Interact in a team atmosphere, providing expertise in general analytical techniques.* Troubleshooting and repair of minor problems in analytical instruments.* Responsible for laboratory work area housekeeping.* Assist with raw data review, analysis, report writing and laboratory investigations (OOT/OOS).* Ensure that responses to regulatory inquiries are conducted in accordance with regulatory guidelines and in consideration of business implications.Job Qualifications* BS/MS in Chemistry.* Minimum 3 - 5 years of pharmaceutical experience in an R&D analytical laboratory supporting small molecule, protein and peptide development programs.* Strong analytical skills, proven experience in wet chemistry, HPLC, Dissolution, KF, GC and spectrophotometry. * Thorough knowledge of cGMPs, compendia requirements, FDA and EMA regulations.* Experience working with and interpreting regulatory documents such as CFRs, FDA and ICH Guidance documents.* Excellent written and oral communication skills with an ability to prepare and present concise, technical data reports to non-scientific counterparts.* Prior experience with FDA/EMA inspections and audits a plus.* Proficiency in standard office software (MS Word, Excel, PowerPoint).* Must be detail oriented and organized with excellent documentation practices.

Keywords: Comrise, Newark , Analytical Scientist (Drug Development), Other , Hackettstown, New Jersey

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