Quality Engineer / Prodigy CAR-T Manufacturing / Hybrid Work from Pioneer Data Systems
Rockville, MD 20850
About the Job
Our client, a world-leading Pharmaceutical Company in Rockville, MD is currently looking for a Quality Engineer to join their expanding team.
Position Details:
- 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.