What are the responsibilities and job description for the Process Development Scientist II position at Thermo Fisher?
How will you make an impact?
As a Process Development Scientist, you will help our clients to deliver lifesaving and life changing therapies to patients in need. You will be responsible for planning, executing, and documenting laboratory and tech transfer activities in support of process assessment, establishment, pilot, and transfer into cGMP manufacturing and in late-phase Process Characterization of viral vector manufacturing processes. You will also act as a subject matter expert (SME) and support a seamless transfer and operation of internally developed and client transferred processes into the PS laboratory and pilot space and out to the cGMP manufacturing space.
What will you do?
Act as a SME for technology transfer and late-phase development for upstream and downstream viral vector therapeutic processes
Collaborate with Process Development and Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.
Assist in operation of the process development laboratory including maintenance of inventory, experiment and equipment scheduling, and equipment maintenance
Identify opportunities to technically and operationally improve systems, practices, and technologies
Collaborate with other Thermo Fisher Scientific sites and clients to ensure success of scale-up and process transfer.
How will you get here?
Education
B.S. in Chem Eng., Biochemistry, Biology, or related field with 3 yrs., Masters or Ph.D.
Experience
Technical experience in upstream and/or downstream biopharmaceutical process development and/or manufacturing
Experience with technology transfer and facility fit assessment is desired
Strong interpersonal and communications skills; written and oral
Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
Knowledge of statistical analysis methodology and software (JMP or equivalent) is highly desired
Knowledge, Skills, Abilities
Strong troubleshooting skills and ability to solve complex technical issues
Ability to compile, analyze and interpret complex scientific data
Working knowledge of cGMP and regulatory requirements of biopharmaceutical manufacturing.
Project management skills desirable.
Ability to function in a rapidly changing environment & handle multiple priorities.
A flexible work schedule is required including Weekend and night as needed to support lab activities.