Analytical Development Project Representative III

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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 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 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 include standing/walking, lifting up to 35 lbs, and manual dexterity for lab work
• Ability to work safely with laboratory chemicals and equipment while following SOPs