Excellent Medical Facility looking to add experienced 2nd Shift Supervisor, Genomic Medicine Bioanalytics, CT Flow Cytometry professional to their team!
This position resides within the Unit, a part of the company's CMC Development organization. The group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust flow cytometry methods to support in-process, release and characterization testing of different cellular therapy candidates. In addition, the group supports cGMP-compliant release and stability testing of clinical supplies performing both the product-specific as well as compendial methods.
We are looking for a skilled and highly motivated scientist with broad expertise in immunophenotyping and cell sorting method development to join the group.
Overview of role
The primary accountability is to perform and develop flow-based analytical methods, cGMP testing, and validation activities. In addition, the GMU CT Flow Group will be responsible for introducing new technologies and ways of working to enable rapid progression of various early-stage cell and gene therapy candidates into the clinic.
- Performs all activities in accordance with cGMP requirements and reports discrepancies. Initiates and complete laboratory discrepancy events within expected timelines
- Provide and supervise analytical support for manufacturing operations, including qualification of in-process and release methods and assist in tech transfer internally and externally in support of GMP manufacturing and release of clinical material.
- Acquire a working knowledge of flow cytometry for routine testing, method validation and method transfer process.
- Documents testing activities and results, ensuring completeness and accuracy per cGMP.
- Contributes toward the development, revision, application, maintenance, validation and review of method SOPs. Initiates and follows up on change request for SOP revision.
- Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports which support regulatory filings.
- Perform assay training and supports qualification of junior analysts.
- Provide technical oversight and manage the workload for a few junior analysts.
- Other duties as assigned.
- Ph.D. in Molecular Biology/Biochemistry/Biology or related discipline or master’s degree with a minimum of four years of relevant industry experience, or a bachelor’s degree with a minimum of six years of relevant industry experience
- Experience in a cGMP environment and ability to adhere to all appropriate cGMP standards (e.g., invalid result investigations, deviations, and CAPAs)
- Experience leading a small team.
- Able to follow instructions and SOPs precisely and able to keep accurate and contemporaneous documentation.
- Able to learn new skills rapidly and achieve proficiency. Detail-oriented with good written and verbal communication skills
- Ability to solve problems of moderate complexity and troubleshooting as necessary.
- Team player with good interpersonal skills
- Self-motivated with excellent organization, time-management, and communication skills
- Experience authoring SOPs
- Previous working experience in aseptic techniques and in flow cytometry is required.
- Experience with transferring methods between groups in a cGMP environment
- Experience with validation and transfer analytical methods.
- Experience in maintenance of GMP laboratory, laboratory equipment, and the status of pipettes and supplies.
- Experience using Quality by Design (QbD) principles and have used Design of Experiment (DOE) approaches for method development/optimization.
- Ph.D. in Molecular Biology/Biochemistry/Biology or related discipline or Master’s degree with a minimum of four years of relevant industry experience, or a Bachelor’s Degree with a minimum of six years of relevant industry experience.
- Experience in a cGMP environment and ability to adhere to all appropriate cGMP standards (e.g. invalid result investigations, deviations, and CAPAs).
- Experience leading a small team.
- Looking for someone with GMP experience.
- Someone who is willing to learn.
- Leading a small team - 2 people RA's
- Looking for manufacturing background
Benefits - Full
Relocation Assistance Available - Yes
Commission Compensation - No
Bonus Eligible - No
Overtime Eligible - No
Interview Travel Reimbursed - No
2+ to 5 years experience
Seniority Level - Mid-Senior
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Never
***Excellent Pay Structure
***Full-time Position w/Excellent Benefits Package
***Relocation Assistance Available For The Right Candidate