R&D/Mfg Scientist II-Reviewer

About the role

Independently perform complex data reviews in support of validations, development testing, protocols, and reports. Provide support for in-process, release, and stability testing, and dedicate functions to laboratory Integrity Compliance activities as mandated by corporate standards.

The role operates in a laboratory setting with a standard work schedule (Monday–Friday).

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 designated software systems for approval (LIMS/SLIM).
• Trend data where applicable to ensure requirements are met.
• Ensure all laboratory testing and activities comply with regulations, ICH guidelines, USP/EP Pharmacopeia, GMP, and data integrity requirements.
• Assist in trainings as a Subject Matter Expert (SME).
• Communicate with Project Lead/Management concerning project status and/or concerns.
• Demonstrate ability to work as a team player in a fast-paced environment.
• Set project priorities and manage time to maximize productivity.
• Actively participate in ongoing trainings and seek opportunities to increase contributions for skill development.
• Work closely with analysts to complete corrections.
• Author and/or review OOS investigations, deviations, change controls, CAPA, technical reports, protocols, validation summaries, and SOPs.
• Ensure all job-related safety training and compliance requirements are met.

Requirements

• Associate’s degree (required) or Bachelor’s degree (preferred) in a scientific discipline, or Associate’s degree with 5 years of pharmaceutical experience and 3+ years of reviewing data for cGMP compliance, or Bachelor’s degree with 3–5 years of pharmaceutical experience and 2+ years of reviewing data for cGMP compliance.
• Advanced knowledge and experience in Empower.
• Advanced knowledge in HPLC, UV, FT-IR, Karl Fischer Titration.
• Preferred experience: IEF, ELISA, CGE, Dot-Blot.
• Demonstrated 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, and potency.
• Data trending and interpretation of analytical results.
• Strong knowledge of GMP and 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.