Analytical Development Project Representative III

Description

Join our team at Thermo Fisher Scientific as an R&D/Manufacturing Scientist III and make meaningful contributions to pharmaceutical development. In this role, you'll be a part of a core team as the Analytical Chemistry SME and point of contact for complex technical projects involving formulation development, process optimization, and technology transfer for pharmaceutical products. Working with advanced analytical technologies and equipment, you’ll serve as a technical subject matter expert regarding method development and validation, analytical testing, and scientific problem-solving. This is a client-facing role that consistently provides updates and solutions to clients and internal stakeholders to help advance drug development from pre-clinical through commercialization stages.

Requirements

• Advanced degree plus 6 years of experience, or Bachelor's degree plus 10 years of pharmaceutical industry experience
• PREFERRED FIELDS OF STUDY: Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Engineering or related scientific field
• Experience presenting scientific and technical information to clients and cross-functional teams
• Expertise in analytical techniques including HPLC, GC, Karl Fischer, spectroscopy and related instrumentation
• Expertise in method development and method validation, preferred
• Knowledge of USP/EP/JP compendials
• Proficiency and expertise with LIMS systems
• PREFERRED EXPERIENCE WITH SCIENTIFIC WRITING SUCH AS METHOD VALIDATION PROTOCOLS AND REPORTS
• Leading and documenting out of specification investigations with experience with lab incidents
• Strong knowledge of GMP requirements and pharmaceutical regulatory guidelines such as ICH
• Demonstrated ability to manage multiple complex technical projects simultaneously
• Strong data trending and ability to recognize and evaluate data trends
• Proficiency with Microsoft Office applications and analytical software
• Advanced problem-solving and troubleshooting abilities
• Strong written and verbal communication skills
• Experience supporting and developing team members through technical guidance

Physical Requirements

• Standing/walking
• Lifting up to 35 lbs
• Manual dexterity for lab work
• Ability to work safely with laboratory chemicals and equipment while following SOPs