Director, Quality Control
EGenesis
Administration, Quality Assurance
Cambridge, MA, USA
Posted on Nov 16, 2024
COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
POSITION SUMMARY
The Director of Quality Control will be leading the Quality Control Unit at eGenesis designing and establishing the analytical operations supporting the various projects in the company’s pipeline. The ideal candidate shall demonstrate strength in communication and team leadership in a critical role that will be broadly engaged across the Organization. In this position the ideal candidate will be responsible for designing the structure of the QC Unit and developing the plan to transition analytical activities, such as Analytical Test Methods, from Research & Development to a GxP compliant phase. This position reports to the Head of Quality and is a high visible and impactful position requiring concurrent strategic and tactical contributions. This position will be located in Cambridge, MA with travel to the Midwest quarterly.
PRIMARY RESPONSIBILITIES
- Establishing the QC Unit including leading instrument IQ/OQs and Analytical Test Methods transfers, qualification, and validation (phase appropriate).
- Hiring and on-boarding QC personnel per recruitment plan.
- Leading the development of Policies, SOPs, and Test Methods required for the operation of the QC laboratory under GxP conditions.
- Leading the implementation of an electronic Data Management System.
- Establishing and leading the process to perform analytical testing of raw materials (phase appropriate) and drug products.
- Establishing programs such as Reference Standards and Sample Management.
- Supporting data management, trending, and data integrity analysis/investigations.
- Oversight of laboratory investigations, Out-of-Specifications (OOSs), and Change Controls related to the analytical operations.
- Oversight of the Stability Program at eGenesis.
- Oversight of Contract Testing Laboratories, as applicable.
- Issuance of QC documentation, such as Certificate of Analysis (CoA).
- Developing curricula for training analysts.
- Supporting the evaluation of Environmental Monitoring conducted in the eGenesis’ manufacturing facility.
- Maintaining the QC Unit in a state of compliance and inspection readiness.
TECHNICAL QUALIFICATIONS
- Ph.D. in Biological/Analytical Sciences with a minimum of ten years, or B.S./M.S. with fifteen years of experience in GxP Quality Control.
- In-depth knowledge of FDA/EMA/ICH regulations and guidelines; pertaining particularly to Cell Therapy/Gene Editing product development platforms.
- Expertise in Cell Therapy/Gene Editing Analytical Methods ranging from molecular biology, cell biology, flow cytometry, biochemical, and biophysical assays.
- Experience in drafting study protocols, reports, and compliance documents.
- Experience in Environmental Monitoring.
LEADERSHIP QUALIFICATIONS
- Solid organizational, staff mentorship, and time management skills with attention to details.
- Proven ability to negotiate, influence, and work in a cross-functional environment.
- Handling multiple assignments in a fast-paced environment with changing priorities.
- Independent development and execution of plans with minimal supervision.
- Strong analytical problem solving and critical thinking skills.
- Excellent written and oral communication skills.