Position Details:
Our client, a world-leading Pharmaceutical Company in Rockville, MD is currently looking for a Quality Engineer to join their expanding team.
Job Title: Quality Engineer / Prodigy CAR-T Manufacturing / Hybrid Work
Duration: 12 months contract, extendable up to 24 months
Location: Rockville, MD
Hybrid: onsite 3-4 days a week
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Manufacturing Oversight Lead - CAR-T Manufacturing
External Supply / Manufacturing Oversight Lead.
We are looking for someone that is able to perform manufacturing oversight of an external contract manufacturing organization producing a Phase Ib clinical CAR-T program.
This person will be responsible for working with the contract manufacturing organization to drive improvements, oversee manufacturing operations, ensure collaboration and communication, and execute tasks such as manufacturing investigations, change controls, batch record revisions, continuous improvement efforts and corrective and preventative actions.
Notes:
Role is Hybrid, must be local to Rockville, MD (onsite 3-4 days a week)
Must have a Bachelor's Degree
Oversight on products for the Cell & Gene Therapy Program
Must have Contract experience
This group processes 2 batches per week
The volume is HIGH, so they need help with oversight of their facility, overseeing the processes and getting the products out the door
CAR-T Manufacturing experience required
Clean Room (ISO 7 / ISO 5 level) experience
Aseptic environment experience
Must have excellent communication skills
Prodigy manufacturing experience
Experience working with CMOs
Experience with Large Molecule Manufacturing experience
Education Needed:
Degree in a Science / Engineering related field required, with preferred focus or experience in pharmaceutical manufacturing.
Bachelor's in science related field / Engineering required
Minimum 3-5 years' experience in pharmaceutical manufacturing, with preference in cell and gene therapy manufacturing.
Preferred experience with contract manufacturing organizations.
Job Types: Full-time, Contract
Benefits:
- 401(k) matching
- Life insurance
- Paid time off
Experience level:
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
- Hybrid work
- Manufacturing facility
Experience:
- CAR-T Manufacturing: 2 years (Required)
Ability to Commute:
- Rockville, MD 20850 (Required)
Ability to Relocate:
- Rockville, MD 20850: Relocate before starting work (Required)
Work Location: Hybrid remote in Rockville, MD 20850