Sample Management

Perform physical sampling, labeling, distribution (import and export), and monitoring of samples globally
Perform aliquot of biological critical reagents and document in ELN
Perform Quarterly Equipment and logbook review
Perform Review of Equipment Temperature Data
Serve as primary logistics coordinator for major vaccine and biologics franchises in Analytical Research & Development
Perform appropriate second scientist and second person review as required
Build and maintain Research LIMS specifications and specification lists for vaccine and biologics franchises
As required, train on laboratory methods supporting key analytical method transfer activities
Ensure all work is compliant with all regulatory expectations
Follow current Good Manufacturing Practices (cGMP) as they apply to the functions of the position
Basic Minimum Qualifications :
Bachelor's degree in biology, chemistry, or other related degree concentration
Authorization to work in the United States indefinitely without restriction or sponsorship
The ideal candidate would possess :
Strong scientific and organizational skills
Excellent communication (oral and written)
High level of attention to detail, in particular with the preparation of GMP documentation and the work associated with that documentation.
Ability to work independently and on a team
Highly self-motivated, expected to contribute to the work and take ownership of projects
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Experience in classical biochemical assays and molecular biological techniques
GMP experience
Technical writing experience
Experience with regulatory audits

Employment type
Full-time

Work arrangement
No