Director, Technical Operations

5 Days Old

Overview For over 40 years, Charles River Cell Solutions 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 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 Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day. Job Responsibilities Provides technical oversight of the HemaCare Donor Center (main areas of donor operations and donor recruitment). Establishes with the guidance of the CS Medical Director(s) the Donor Center operations best practices and adjustments needed to meet regulatory requirements and to best support commercial revenue generation. In alignment with strategic goals and planning, plays a critical sponsorship role in multiple complex projects to drive revenue growth initiatives (eg. Donor Room Operations/ Donor Base Optimization, Technical Operations, custom projects), working with Cell Solutions PMO office as needed, to ensure capabilities and resourcing meets client demands and leads the market and competition. Serves on the Senior Leadership Team meetings to help set technical operations priorities and focus for Cell Solutions. Ensures that all departments supervised provide high-quality customer service, follow safety guidelines and perform tasks in compliance with the company’s quality program, SOPs, current Good Manufacturing Practices (cGMP) and regulatory agencies and AABB guidelines. Reports and investigates incidents, variances and complaints as outlined in the appropriate SOPs. Supports customer and regulatory audits. Reviews and approves error/accident reports, all related root cause analysis, corrective actions, preventive action and follow-up. Provides appropriate guidance, direction and training to ensure effective resolutions. Responsible, in collaboration with the Director, Manufacturing Operations, to ensure proper staffing capacity to fulfill on-going production needs resulting in timely revenue generation. Develops and manages budget and resources for departments under his/her control. Generates and analyzes reports regarding technical functions and KPIs. Develops production/service or operations and resource plans that meet goals in terms of safety, quality, output, and cost. Applies all applicable OSHA and related local safety requirements to all assigned work and ensures that the facility is within OSHA compliance. Performs additional duties as assigned. Job Qualifications To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience with current Good Manufacturing Practices (cGMPs), current Good Tissue Practices (cGTPs), 21 CFR 1271, FDA and EU cell therapy requirements. 5+ years’ experience in industry standard blood donor center operations including leukapheresis platforms preferred. 5+ years’ or more experience in revenue growth opportunities support with cell and gene therapy clients. 5+ years’ experience building relationships with customers within academic, biotechnology, and/or pharmaceutical organizations. Education, Experience, and Licensure Minimum Bachelor’s Degree in Biological, Chemical, Physical, or Medical Technology or Clinical Laboratory Science, or other technical field, or equivalent education and experience. Blood collection/banking experience is highly desirable. Technical Sales experience is a bonus. Compensation The pay range for this position is $190,000 - $210,000 per year. Salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Charles River Cell Solutions Charles River Cell Solutions 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. The company provides vertically integrated solutions to 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. Combined with Charles River’s integrated portfolio, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers to accelerate programs from basic research to regulatory approval and commercialization. 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 coordinate worldwide resources and apply multidisciplinary perspectives to resolve our client’s challenges. Our client base includes global pharmaceutical and biotechnology companies, government agencies, and hospitals and academic institutions. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying and need special assistance or an accommodation due to a disability to complete any forms or 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 accommodation contact is for individuals with disabilities only and cannot be used to inquire about application status. For more information, please visit www.criver.com.
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Location:
Los Angeles, CA, United States
Job Type:
FullTime
Category:
Management & Operations