NJ Employer Scientist-Analytical Chemistry; Research and Development - NJ(849139) in Summit, New Jersey

DescriptionDescription:Responsible for assisting in method development, conducting method validation, performing laboratory research and/or routine sample analysis on API and solid oral dosage form under minimal guidance of a supervisor.Responsibilities will include, but are not limited to, the following:Assist to carry out method development, optimization and validation for the analysis of drug substances, and finished products in accordance with cGMP regulations, established protocols, and applicable SOPs.Adhere to all pertaining compliance requirements.Contribute data for preparation of development, validation and technology transfer reports.Communicates results according to project timelines and works with colleagues and collaborators to understand project needs.Performs troubleshooting within method guidance.Performs reference standard qualification/requalification tests.Performs release and stability testing in accordance with established methods, specifications and protocols with limited supervision.Documents laboratory work that is detailed, timely and in compliance with GLP/GMP requirements.Other duties as assigned by his/her supervisor.Skills/Knowledge Required:Experience with HPLC, GC, FT-IR, KF, dissolution methods developing and testingIn-depth knowledge of cGLP/GMP; applicable FDA and ICH guidance a mustFamiliar with USP and other compendiaWorking knowledge of Empower required.Must have working familiarity with cGMP practice and safety awareness for analytical laboratories.Working experience in pharmaceutical industry: 8 years for BC, 7 years for MS, or 5 years for Ph.D.VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here. https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf