Associate Scientist-Stability

3 weeks ago


New Haven, United States Integrated Resources, Inc ( IRI ) Full time

Integrated Resources, Inc ( IRI ) provided pay rangeThis range is provided by Integrated Resources, Inc ( IRI ). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$36.00/hr - $37.00/hrDirect message the job poster from Integrated Resources, Inc ( IRI )Lead Recruiter at Integrated Resources Inc. (IRI)This is what you will do:The Stability Associate II is responsible for performing assigned tasks to support stability activities for Client's clinical phase candidates from development through Phase III and support Commercial Products. The Stability Associate II will work in collaboration with members of Analytical Sciences (AS), Biological Drug Substance Development (BDSD), Injectable Drug Product Development (IDPD), Device Development (DD), Quality Assurance (QA), and other members of Product Development and Clinical Supply (PDCS) as well as external vendors as required.You will be responsible for:Responsible for all aspects of on-site stability sample storage and sample managementConduct Stability sample pulls at scheduled timepoints according to approved stability study plansDeliver stability samples to labs and perform aliquots as needed, following Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs)Perform data entry/review within paper-based and electronic systemsPoint-of-contact between on-site testing labs and stability groupAuthor stability Protocols, Reports, SOPs and Quality documents as requiredWork with internal stakeholders to provide testing requirements and obtain completed analytical test resultsTrack stability results generated internally and at external CMOs/ CLOsDocument stability results with a strong attention to detail; able to recognize trends outside of expected results and communicate to management as requiredPerform all job functions in compliance with cGMPs and maintain accurate and legible recordsEnsure training is current for all job functions performed. Attend all required Company trainingYou will need to have:Bachelor’s degree with previous experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience)Knowledge of GxPs and their application in the pharmaceutical environment is requiredAble to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasksAbility to interact with cross-functional teams while representing the stability groupAble to navigate external vendor sites and portals for data extraction and review, as neededAble to communicate findings effectively to colleagues within and outside of the group through presentationsProficient with various MS Office programs, including Word, Excel, Outlook, and PowerPointThe ability to communicate verbally and in a written format is requiredAble to understand and follow written proceduresWe would prefer you to have:Working knowledge of governing documents/regulations for pharmaceutical stabilityPrevious experience with SAS JMP or other statistical softwarePrevious experience with Laboratory Information Systems (LIMS)Seniority levelAssociateEmployment typeContractJob functionResearchPharmaceutical Manufacturing and Biotechnology ResearchReferrals increase your chances of interviewing at Integrated Resources, Inc ( IRI ) by 2x #J-18808-Ljbffr


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