Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

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