R&D/Mfg Scientist II-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