Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Will work with hazardous/toxic materialsJob 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 us as a Staff Scientist in Manufacturing Sciences and contribute to excellence in process development and manufacturing optimization. You'll provide technical leadership in developing, validating, and implementing robust manufacturing processes while collaborating across multiple departments to ensure successful scaling and optimization of new and existing processes. Make meaningful contributions to innovative solutions that help our customers make the world healthier, cleaner, and safer.
As a key technical expert, you'll lead complex projects, provide manufacturing support, conduct process improvements, and drive technology transfer initiatives. You'll collaborate with cross-functional teams including R&D, Quality, Engineering, and Production to achieve project goals and maintain high quality standards. Your expertise will be essential in troubleshooting, optimizing processes, and implementing data-driven solutions while ensuring compliance with regulatory requirements.
REQUIREMENTS:
• Advanced Degree plus demonstrated track record , or Bachelor's Degree plus Extensive hands-on experience in process development, scale-up, and manufacturing optimization
• Subject Matter Expert (SME) in lyophilization (freeze-drying) process development and optimization, with experience in cycle design, scale-up, troubleshooting, and ensuring product quality and regulatory compliance.
• Preferred Fields of Study: Chemistry, Chemical Engineering, Biochemistry, Biomedical Engineering, Polymer Chemistry, Process Engineering, or Biologics Manufacturing
• Deep technical expertise in process development, scale-up, and manufacturing optimization
• Strong background in GMP manufacturing and regulatory compliance (FDA, EMA, ISO)
• Experience leading cross-functional teams and managing complex technical projects
• Advanced analytical and problem-solving skills with expertise in statistical analysis and DOE
• Proven ability to troubleshoot complex process issues and implement corrective actions
• Strong documentation skills including SOPs, batch records, validation protocols and reports
• Expertise in data analysis, process modeling, and trending
• Experience with quality systems and risk assessment methodologies
• Excellence in technical writing and presentation skills
• Strong interpersonal and communication abilities for collaborating with internal/external stakeholders
• Ability to work in cleanroom/GMP manufacturing environments
• Proficiency with statistical software and standard business applications
• Travel may be required (<20%) to other sites
• Experience developing and supporting team members
• Knowledge of Lean/Six Sigma methodologies preferred
About Thermo Fisher:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.