Role at a glance
- Salary
- Not Disclosed
- Location
- Greenville, North Carolina, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- 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
- Education
- Associates degree required -bachelor’s degree preferred) All degrees must be from a scientific discipline or Associates degree with 5...
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Role Summary
The R&D Scientist II-Reviewer independently reviews complex analytical data supporting validations, development testing, protocols, and reports. The role also supports in-process, release, and stability testing, as well as laboratory integrity compliance activities.
What You'll Do
- Review cGMP analytical data for adherence to procedures and standards, and determine whether reported results meet specifications or...
- Verify data entry in LIMS/SLIM and trend data where applicable.
- Support validation and development testing, protocols and reports, and in-process, release, and stability testing.
- Ensure laboratory testing and activities comply with regulations, ICH guidelines, USP/EP Pharmacopeia, GMP, and data integrity requirements.
- Work with analysts to complete corrections and assist with training as a subject matter expert.
- May author or review OOS investigations, deviations, change controls, CAPA, technical reports, protocols, validation summaries, and SOPs.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
A scientific-discipline associate degree is required, with the stated associate- or bachelor’s-degree experience pathways. Qualifications also include advanced knowledge and experience in Empower; advanced knowledge of HPLC, UV, FT-IR, and Karl Fischer titration; knowledge of method validation; strong knowledge of GMP and GLP regulatory requirements; Microsoft Office proficiency; and fluent English.
Required
- A scientific-discipline associate degree is required; the posting also lists associate- and bachelor’s-degree experience pathways.
- Advanced knowledge and experience in Empower.
- Advanced knowledge of HPLC, UV, FT-IR, and Karl Fischer titration.
- Knowledge of method validation.
- Strong knowledge of GMP and GLP regulatory requirements.
- Proficiency in Microsoft Office applications.
- Fluent in English.
- Strong organizational, communication, and leadership skills; ability to manage multiple priorities and deadlines; ability to work...
Preferred
- Bachelor’s degree is described as preferred.
- IEF, ELISA, CGE, and Dot-Blot are listed as preferred.
- Experience with analytical method development, validation, transfer, and verification for drug products and raw materials is advantageous.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Laboratory SettingJob 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
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.