R&D Mfg Scientist 2-Reviewer

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Laboratory Setting **Job Description** The R&D Scientist II-Reviewer independently performs complex data reviews in support of validations, development testing, protocols and reports.  In addition, the reviewer is to provide necessary support of in-process, release and stability testing. The reviewer functions are also dedicated to laboratory Integrity Compliance activities as mandated by corporate standards. **Key Responsibilities:** * Perform cGMP analytical data review for various techniques to ensure adherence to established procedures, analytical standards, GVLs and SOPs * Determine if reported data meets specification or expected standards * Verify that data is correctly entered into its designated software systems for approval (LIMS/SLIM) * Trend data where applicable to ensure requirements are met * Ensure that all laboratory testing and activities are carried out in compliance with regulations, ICH guidelines, and USP/EP Pharmacopeia, GMP and  data integrity requirements * Assist in trainings as an SME * Communicate with Project Lead/Managment concerning project status and/or concerns * Demonstrate ability to work as a team player and in a fast-paced environment * Must be able to set project priorities and time management in order to maximize productivity * Actively participate in ongoing trainings and seek out opportunities to increase contributions for development of skills and responsibilities * Work closely with analyst to complete corrections * Might Author and/or review: OOS investigations, Deviations and Change Controls, CAPA, technical reports, Protocols and validation summaries , SOPs * Ensure all job-related safety training and compliance requirements are met **Qualifications:** * Associates degree required -bachelor’s degree preferred) **All** _degrees must be from a scientific discipline or_ * Associates degree with 5 years of pharmaceutical experience and 3 or more years of reviewing data for cGMP compliance or * Bachelor’s degree with 3-5 years of pharmaceutical experience and 2 or more years of reviewing data for cGMP compliance * Advanced knowledge and experience in Empower * Advanced knowledge in HPLC, UV, FT-IR, UV, Karl Fischer Titration, IEF (Preferred), ELISA (Preferred),  CGE (Preferred), Dot-Blot  (Preferred) * Demonstrate knowledge in method validation * Experience with analytical method development, validation, transfer, and verification for drug products and raw materials is advantageous * Experience testing for assay, impurities, content uniformity, potency * Data trending and interpretation of analytical results * Strong knowledge of GMP, GLP regulatory requirements * Strong organizational, communication, and leadership skills * Ability to manage multiple priorities and meet deadlines * Proficiency in Microsoft Office applications * Demonstrated ability to work independently and collaboratively * Fluent in English