Overview
On Site
$70 - $100
Contract - W2
Contract - 6 Month(s)
No Travel Required
Skills
Crystal Management Console
Chemistry
Biologics License Application
Regulatorybackground
Job Details
Job Title: Sr. CMC SME (Biotech/Pharma) Location: Carlsbad, CA (100% Onsite) Duration: 6 months Pay Rate: $70/hr - $100/hr (depending on experience)
Job Description:
Client's BLA (Biologics License Application) target is early next year.
Need a CMC (Chemistry, Manufacturing & Controls) SME to make sure manufacturing process is set, and BLA can be filed on time.
Need someone with both manufacturing CMC and some regulatory background as well.
Must Have Skills/Experience:
15+ years experience in CMC
Bringing products to BLA
Viral vector experience
Nice to Have Skills/Experience:
Gene therapy experience
Process validation experience
Analytical background
Regulatory background
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.