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R&D Mfg Scientist II - Analytical Development
On-site · Greenville, North Carolina, United States
Job Summary
As part of Thermo Fisher Scientific, provides routine analyses in a biochemistry environment to support process development and/or manufacturing. Leads validation of test methods for pharmaceutical raw materials and finished products (strength, impurities, identity, potency, dissolution) using HPLC, GC, LC/MS, and related techniques; recognizes out-of-specification results and non-routine analytical issues; writes deviations, CAPA, Change Controls, SOPs and specifications; performs instrument calibrations and runs validation protocols per regulatory guidelines; reviews results and communicates findings; conducts routine tasks and sample analyses to support development; collaborates with clients and teammates to develop new methods and processes that meet client expectations; ensures compliance with GMP/GxP and safety guidelines. Requires a Bachelor degree (or Master’s with related experience) and hands-on experience with analytical methods in pharmaceutical contexts; strong technical, analytical, and documentation skills; capable of operating with attention to detail in a regulated laboratory setting.
Required Qualifications
- Bachelor degree in Chemistry, Biochemistry, Molecular Biology, or related physical/biological science field minimally required with 3+ years related experience
- Master’s degree, 1+ year related pharmaceutical industry experience strongly preferred
- Experience with HPLC and Dissolution
- Experience performing method development and validation, chemical tests with chromatographic, spectroscopic, or other analytical techniques preferred
- Experience with EMPOWER preferred
- Equivalent combinations of education, training, and meaningful work experience will be considered
- Good knowledge and understanding of chemistry and analytical instrumental technologies
- Good knowledge of qualitative and quantitative chemical or microbiological analysis
- Awareness of quality and regulatory requirements in the pharmaceutical industry
- Strong interpersonal and communications skills, written and oral
- Ability to read, analyze, and interpret technical procedures and governmental regulations
- Excellent organization and planning skills
- Strong attention to detail and ability to implement to standard procedures
- Ability to design and complete tasks and studies based on the deliverables
- Ability to accurately detail work and write reports
- Physical requirements as described in posting
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