-Degree in a Science / Engineering related field required, with preferred focus or experience in pharmaceutical manufacturing.
-Minimum 5-7 years' experience in pharmaceutical manufacturing within cell & gene therapy
-Minimum 2 years of experience of technical writing
-Strong in Root Cause Analysis in a Pharmaceutical environment
-Experience working with CMO / CDMO
Nice to Have Skills and Experience:
CAR-T experience
Preferred experience in working with the CliniMACS Prodigy Instrument
Preferred experience with contract manufacturing organizations.
Job Description:
This position will perform manufacturing oversight of an external contract manufacturing organization producing a Phase Ib clinical CAR-T program as a person in plant. Additionally, this position will be responsible for supporting the CMO manufacturing organization in the following activities:
-Manufacturing Support Operations -- Supporting CMO operators in manufacturing execution activities.
-Support in technical writing for investigations / deviations and change controls.
-Support in the execution and implementation of CAPAs.
-Support in technical writing for batch records, SOPs, and other documents as needed.
-Support in material ordering and ensuring sufficient supply of raw materials / process consumables.
-Support in data transcription and analysis for manufacturing in process and release data.
This position will be responsible for working with the contract manufacturing organization to drive improvements, oversee and support in 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.
Compensation:
$45/hr to $50/hr.
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.