Associate Director, Technical Excellence

Associate Director, Technical Excellence

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, Technical 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>

) products.

Essential 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 updated 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.

Job Qualifications

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>

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.

Compensation Data

The pay rate for this role is $150,000 - $160,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About HemaCare

HemaCare, a Charles River company, is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. HemaCare's vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections. In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River's integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes. Together, with over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical and biotechnology companies, government agencies, and hospitals and academic institutions around the world. At HemaCare, we are passionate about our role in improving the quality of people's lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone's life.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit www.criver.com and www.hemacare.com.