Job Description

　　HOURS: Monday to Friday, 8:00 am to 5:00 pm

　　DUTIES:

　　Develop and evaluate analytical methods that support routine testing of biopharmaceutical process development and GMP manufacturing.

　　Execute studies to support method and formulation development, structural characterization, comparability, forced degradation, and other development activities for biopharmaceuticals at all stages of clinical development.

　　Collaborate with Quality Control, Manufacturing, and other Operations groups to develop, qualify, and transfer analytical methods, and troubleshoot and improve existing analytical methods.

　　Research and implement new methods and technologies to enhance operations.

　　Execute, record, and evaluate experimental data appropriately, including the writing and revising of process development reports and technology transfer protocols as needed.

　　Assist with the design of experimental plans based on defined deliverables.

　　Conduct sample analyses to support process development, and provide complex analyses by using defined procedures and practices.

　　Assist with preparing protocols, reports, and test methods.

　　Maintain and ensure safe laboratory environment and work practices, and order common supplies.

　　REQUIREMENTS: Master’s degree in Chemistry, Chemical Engineering, or a related field of study. Employer also accepts a Bachelor’s degree in Chemistry, Chemical Engineering or a related field of study and 2 years of experience in pharmaceutical manufacturing, academic laboratories, or a related occupation.

　　Must have experience or knowledge of:

　　Occupational health and safety policies and procedures;

　　Good laboratory practices;

　　Chromatography techniques including size exclusion, ion exchange, and affinity chromatography;

　　Empower, Chromeleon, ChemStation, or similar chromatography data system;

　　Analytical quality by design (AQbD) principles;

　　Designing and executing studies based on scientific deliverables.

　　TRAVEL: None.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.