Associate Director, Technical Excellence

Charles River Laboratories•Los Angeles, CA

45d•$150,000 - $160,000

About The Position

For over 40 years, HemaCare, a Charles River company, has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies. We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making HemaCare a rewarding and valuable place to work. We believe in making a difference, and at HemaCare, you will make a difference every day. Job Summary The Associate Director, Scientific Operations Excellence is responsible for oversight of Technical Operations following current Good Laboratory Practice (cGLP) and current Good Manufacturing Practice (cGMP) compliant Cell & Gene Therapy (C&GT) products..

Requirements

M.S or higher in Life Sciences disciplines, with 10 years of Pharmaceutical, Cell Biology, Immunology, Biotechnology, OR Cell and Gene therapy industry experience required.
Minimum 5+ years of personnel management experience in industry setting.
Experience with current Good Manufacturing Practices (cGMPs)/21 CFR210-211, FD and EU C&GT requirements, USP and ISO compliance; direct experience with in-person regulatory inspections/audits highly desired.
Specialize with downstream process analysis, development, and improvement
Hands-on experience with cell and molecular biology and biochemical laboratory equipment techniques.
Track record of processing large amounts of complex information and data to provide accessible summaries to other staff and managers.

Responsibilities

Support the needs of the directly-reporting departments, as applicable, but not limited to Clinical Laboratory, Quality Control, Clean Room, Production Planning and R&D.
Collaborates with the GM on special projects, meeting strategic goal initiatives and driving execution in collaboration with Operations staff, Client Services, Donor Ops and PMO.
Responsible, in collaboration with the Director, Manufacturing Operations, and Production Planning to ensure proper staffing capacity to fulfill on-going production needs resulting in timely revenue generation.
In alignment with strategic goals and planning, plays a critical sponsorship role in multiple complex projects to drive revenue growth initiatives (eg. Technical Operations, custom projects, R&D).
Provide technical support as needed for all laboratory operations including troubleshooting, product quality concerns, and resolution of customer issues.
May serve as needed on the Leadership Team meetings to help set technical operations priorities and focus for Cell Solutions.
Ensure that best industry practices are followed and areas for improvement are detected and timely acted upon. Workflow and processes should be mapped and undated to align with global practices as applicable. Assist with maximizing productivity and efficiency while minimizing costs and downtime; monitor progress towards deliverables. Responsible for providing periodic capacity analysis.
Executes on laboratory-related audit findings and drives timely completions of deviations, CAPAs and change controls within the standard timeframe.
Support and drive scientific innovation and efficiency including producing KPIs for maintaining optimal operational excellence and reporting to operations QMR.
Ensure compliance with protocols and all applicable SOPs.
Introduce new technologies or improvements in existing technologies.
Drive process improvement, new technology implementation, new product development and other critical development strategies.
Understand and apply the most relevant scientific and technical knowledge in applications of human primary cells across cell-based assays, immunology, stem cell biology, genomics, cell biology, neurosciences, and other scientific fields.
Provide supervision of the facility, equipment, and personnel. Ensure consistent laboratory presence and direct line-of sight with personnel in each directly-reporting department through daily lab walk-arounds and interaction with staff through regular huddles and lab group meetings weekly.