A global cell and gene therapy organization is looking to add a Quality Control Lab Manager to lead their actively growing Quality Control Team! This company has grown their size by over ten times in just a matter of three years promising professional growth, stability, and plenty of room for career advancement. With plans of continuous growth, now's the time to join this amazing organization!
Key Job Responsibilities:
- Responsible for the supervision of the Cell Therapy team for the specific shift.
- The advisor for determining how to meet the schedules and/or resolve any technical issues.
- Ensuring that testing and laboratory records are compliance with cGMP and the organization's policies and principles.
- Collaborating with other QC Cell Therapy Managers, Supervisor and Leads to ensure successful in-process testings including Flow Cytometry, manual and automated cell counts, and hematology analysis.
- Authors, checks, and/or provides approval of SOPs, sampling plans, protocols, and specifications.
- Draw up responses to audits, out of specification/lab investigations, customer complaints, deviations and CAPA
- Leads technical investigations.
- Develops project plans, author status reports, and performs oral presentations to customers and management.
- Conducts technical review of Statements of Work (SOWs).
- Draw up monthly management reports such as budget analysis and project updates.
- Reports to the Sr. Manager of Quality Control.
Qualifications:
- Bachelor's degree (B.S.), Master's degree preferred
- Minimum of 7 years of experience in Quality Control
- Background in Cell Therapy
- Experienced in biological, cell-based assays such as flow cytometry, ELISA, and PCR
- Knowledge on LIMS, SAP and TrackWise is a plus
- Experienced with method validation and technology transfer preferred
Benefits:
- Competitive base salary and bonus
- Provides Relocation Package
- Offers sponsorship
