Position type: Full time
Job Code: 0023
Required education: High school or equivalent
Area(s) of expertise desired: Process Development

DESCRIPTION
The appropriate candidate needs to have hands-on experience in cell-based product manufacturing process development and qualification. This includes broad tissue culture experience (especially hematopoietic cells, primary cells and progenitor cells), aseptic technique, and experience operating and maintaining cell processing equipment, (including but not restricted to bioreactors, Cell Factories, COBE Cell Processors, Cytomate Cell Processors and magnetic separation systems).

ESSENTIAL FUNCTIONS

1. Development of processes for the manufacture of cell-based therapeutics, including yield and media optimization, process streamlining and cost of goods reduction.
2. Scaling up of processes and enhancement of regulatory compliance.
3. Development of final product formulations.
4. Execution of stability series to include raw material, in-process intermediate and final product.
5. Writing of development SOPs, development process production records and technical reports.
6. Performs any and all required processing and testing required to produce and assess safe and efficacious products. Performs additional duties as assigned.
7. Consistently produce a high level of documentation accuracy and clarity.
8. Cryopreservation of products using DMSO solutions and rate-controlled freezers.
9. Participating in client-based projects and studies, may include but not limited to:
a. Sample preparation
b. Sample shipping
c. Media and reagent preparation
d. Ordering and receiving supplies.
e. Communicating effectively with supervisor, company management and client team members.

REQUIREMENTS
1. The position requires BS/MS degree in Biology, biochemistry or related fields.
2. The candidate must have 3 – 5 years of relevant experience in the development and manufacture of cell-based therapeutics.
3. Hands-on experience in cell-based product manufacturing process development and qualification is a must. This includes broad tissue culture experience (especially hematopoietic cells, primary cells and progenitor cells), aseptic technique, and experience operating and maintaining cell processing equipment, (including bioreactors, Cell Factories, COBE Cell Processors, Cytomate Cell Processors and magnetic separation systems).
4. Good written and oral communication skills.
5. Detail orientation, troubleshooting and problem solving ability.
6. Teamwork and professionalism in all interactions.
7. Willingness to work flexible hours and shifts when there is a need.