Scientist I, Manufacturing Sciences

at  Thermo Fisher Scientific

EDUCATION

• Bachelor’s degree required in a scientific field, preferably an engineering field.

EXPERIENCE

• 1 years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience.
• Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment.
• Ability to self-motivate, prioritize work and time.
• Demonstrates a foundation in general scientific practices, principles, and concepts.
• Writes and communicates effectively.
• Ability to work both independently and as part of a team.
• Knowledge of current Good Manufacturing Practices and US/EU regulations.
• Knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus.
• Proficient in Microsoft Word and Excel.
• Ability to stand for prolonged periods of time and gown into manufacturing areas.

• Create detailed Process Flow Diagrams, Standard Operation Procedures, and Job Aids.
• Collaborate with the process development to develop standardized methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
• Demonstrate initiative and an eagerness to learn new systems.
• Participate in Internal and Customer meetings guided by supervision.
• Lead projects and manage timelines with support from supervision as needed.
• Actively drive engineering initiatives to improve practices and procedures.
• Provide scientific input for GMP deviations.
• Help devise and implement Corrective and Preventative Actions.
• Lead changes to equipment and process design.
• Draft Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, and Technical Reports, ensuring the process is technically accurate and designed for Manufacturing.
• Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
• Troubleshoot technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility.
• Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers.