Charles River Laboratories is hiring: Associate Director, Technical Excellence i

Associate Director, Technical Excellence

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For over 40 years, HemaCare, a Charles River company, has worked to make a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations developing innovative research and 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.

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.
• Collaborate with the GM on special projects, meeting strategic goal initiatives and driving execution in collaboration with Operations staff, Client Services, Donor Ops and PMO.
• Work with the Director, Manufacturing Operations, and Production Planning to ensure proper staffing capacity to fulfill on?going production needs resulting in timely revenue generation.
• Play 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.
• Serve as needed on Leadership Team meetings to help set technical operations priorities and focus for Cell Solutions.
• Ensure best industry practices are followed, detect areas for improvement and act on them timely; map and update workflow and processes to align with global practices as applicable, maximizing productivity and efficiency while minimizing costs and downtime.
• Execute on laboratory?related audit findings and drive timely completion of deviations, CAPAs and change controls within 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.
• Apply 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.
• Supervise the facility, equipment, and personnel, ensuring consistent laboratory presence and direct line?of?sight with personnel in each directly?reporting department through daily walk?arounds, 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, FDA 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: $150,000 $160,000 per year. Salary varies within this range based on experience, skills, education, certifications, and location.

About HemaCare

HemaCare 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. HemaCares 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. The combined portfolio creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide.

We are passionate about improving the quality of peoples lives. 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.

Benefits

Benefits may include bonus or incentives based on performance, 401(k), paid time off, stock purchase program, health and wellness coverage, employee and family wellbeing support programs, and work?life balance flexibility.

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 need special assistance or an accommodation due to a disability to complete any forms or otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e?mail 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, visit https://www.criver.com and https://www.hemacare.com.