Classification Title:
Research & Development Manager
Job Description:
Management of quality control activities of the current Good Manufacturing Practices (cGMP) including but not limited to the following types of activities:
- Reviews all production and testing documents
- Coordinates with Manufacturing and Quality Control all deviations and Out Of Specification (OOS) failure investigations,
- Assists both Manufacturing and Quality Control with Troubleshoots process and assay problems
- Coordinates testing with production runs and release schedules with both Manufacturing and Quality Control.
- Interacts with the Director of GMP, Assistant Director of Manufacturing and sponsors to coordinate timely manufacturing, testing, audit and release of reagents and products.
- Assists the both Manufacturing and Quality Control with the preparation of progress reports and final reports on results of testing, including oral presentations.
- Provides technical supervision to staff to ensure quality protocols are followed.
Record and Protocol Management-Duties included, but are not limited to:
- Assists with the qualification of the developed assays for use in the QC Lab by writing protocols, coordinating appropriate experiments and writing qualification reports.
- Directs the writing of Standard Operating Procedures (SOPs), QC Reagent Preparation Records (QCRP), Testing Records (TRs), Release Specification documents (RS) and Certificates of Analysis (CoA) and approves in writing these documents.
- Assists with the development of stability protocols for various products and reagents manufactured in the Facility. Maintains stability data.
- Manages all GMP document archives. Maintains accurate records, including data, deviations and laboratory budget, and file management. Technically reviews data, writes reports, and assist in campaign and project planning and time-line development together with the Operations and Sponsors.
REES System Check & REES Probe Inhibition.
- Hazardous Waste Self Audit (C&G).
- LATCH Risk Assessment.
- Annual document review MF Operation Unit.
- Review all completed manufacturing CP, BR, RP paperwork.
- Submit QC Samples (Decision).
- Manage Annual COC from Airgas
Strategy
- Provides mentorship and technical direction to GMP laboratory staff, including in-service training on related Manufacturing and Quality Control topics. May be assigned to one-on-one mentorship and training tasks for onboarding and retraining purposes.
- Acts as resource for GMP staff with the implementation of protocols related to both Manufacturing and Quality Control.
- Serves on internal committees for the creation of Standard Operating Procedures (SOPs), QC Reagent Preparation Records (QCRP), Testing Records (TRs), Release Specification documents (RS) and Certificates of Analysis (CoA) SOPs, workflows, and metrics. Collaborates with leadership and support staff to implement and change policies and/or procedures.
Coordinates and assesses manufacturing methods and assay methodologies for the production and testing of clinical grade cell and gene therapy drug substances and drug products for use in the cGMP compliant QC Laboratory. Assay methodologies may include but not be limited to:
- Flow cytometry, biological functional assays, cytokine quantification assays, infectious center assays, other tissue culture assays, PAGE, ELISA, dot blot, western hybridization, Real-time PCR, and other molecular biology methods.
Expected Salary:
$100,000 – $105,000
Minimum Requirements:
Master’s degree in an appropriate area and seven years of relevant experience.
Preferred Qualifications:
Master of Science (or PhD preferred) with work experience in the GMP operations. Experience in mammalian cell culture, biochemistry, molecular biology and knowledge of the principals of Environmental Monitoring for cGMP facility are required for this position. Experience with human cell therapy techniques is preferred.
Significant experience (> 5 years) in the production of gene and cell therapy clinical trials materials in a GMP environment.
Special Instructions to Applicants:
In order to be considered, you must upload your cover letter and resume.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:
No
Advertised: 15 Sep 2023 Eastern Daylight Time
Applications close: 22 Sep 2023 Eastern Daylight Time