Associate Director, Technical Excellence

Join to apply for the Associate Director, Technical Excellence role at Charles River Laboratories.

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.

#J-18808-Ljbffr\n\nIn Summary: The Associate Director, Technical Excellence is responsible for oversight of Technical Operations following current Good Laboratory Practice and current Good Manufacturing Practice (cGMP) compliant Cell & Gene Therapy (C) products . 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 .\n\nEn Español:

Director asociado, Excelencia técnica

Participar para solicitar el Director asociado, Excelencia técnica papel en el Laboratorios del Río Charles- ¿ Qué ?

Durante más de 40 años, HemaCare ha trabajado para tener un impacto positivo en el mundo proporcionando material y servicios celulares de la más alta calidad a las compañías biotecnológicas y farmacéuticas y organizaciones de investigación que desarrollan investigaciones innovadoras y nuevas terapias basadas en células. Reconocemos que nuestro éxito depende de la visión y pasión de nuestros empleados; por eso nos dedicamos a hacer de HEMACare un lugar de trabajo gratificante y valioso.

El Director asociado, Excelencia técnica es responsable de la supervisión de las operaciones técnicas que siguen los productos de terapia celular y génica (C>) conformes con las buenas prácticas de laboratorio actuales (cGLP, por sus siglas en inglés) y las buenas practicas de fabricación actual (cGMP).

Responsabilidades esenciales

Apoyar las necesidades de los departamentos que informan directamente, según corresponda, pero no limitándose a laboratorio clínico, control de calidad, sala limpia, planificación productiva y I+D.
Colaborar con el Director General en proyectos especiales, alcanzar iniciativas de objetivos estratégicos y impulsar la ejecución en colaboración con el personal de Operaciones, Servicios al Cliente, Ops donantes y PMO.
Trabajar con el Director de Operaciones Fabricantes y Planificación Productiva para garantizar una adecuada capacidad de personal para satisfacer las necesidades continuas de producción que resulten en la generación oportuna de ingresos.
desempeñar un papel crítico de patrocinio en múltiples proyectos complejos para impulsar las iniciativas de crecimiento de los ingresos (por ejemplo, Operaciones técnicas, proyectos personalizados, I+D).
Proporcionar soporte técnico según sea necesario para todas las operaciones de laboratorio, incluida la solución de problemas, preocupaciones sobre la calidad del producto y resolución de los problemas con el cliente.
Servir según sea necesario en las reuniones del Equipo de Liderazgo para ayudar a establecer prioridades técnicas de operaciones y enfoque para soluciones celulares.
Asegurar que se sigan las mejores prácticas de la industria, detectar áreas de mejora y actuar sobre ellas a tiempo; mapear y actualizar los flujos de trabajo y procesos para alinearse con las prácticas globales según corresponda, maximizando la productividad y eficiencia al mismo tiempo que minimiza los costes y el tiempo de inactividad.
Ejecutar los hallazgos de auditoría relacionados con el laboratorio e impulsar la finalización oportuna de las desviaciones, CAPA y controles de cambios dentro del plazo estándar.
Apoyar y impulsar la innovación científica y la eficiencia, incluida la producción de KPI para mantener una excelencia operativa óptima e informar a las operaciones QMR.
Garantizar el cumplimiento de los protocolos y todas las SOP aplicables.
Introducir nuevas tecnologías o mejorar las existentes.
Mejorar los procesos, implementar nuevas tecnologías, desarrollar nuevos productos y otras estrategias críticas de desarrollo.
Aplicar el conocimiento científico y técnico pertinente en las aplicaciones de células primarias humanas a través de ensayos basados en células, inmunología, biología de células madre, genómica, biología celular, neurociencias y otros campos científicos.
Supervisar las instalaciones, los equipos y el personal, asegurando una presencia de laboratorio consistente y un contacto directo con el personal de cada departamento que informa directamente a través de paseos diarios, reuniones semanales en grupos de laboratorio.

Qualificaciones del trabajo

M.S. o superior en las disciplinas de Ciencias de la Vida, con 10 años de experiencia farmacéutica, biología celular, inmunología, biotecnología o industria de terapia celular y genética requerida.
Minimum 5+ años de experiencia en gestión del personal en el ámbito industrial.
Experiencia con las buenas prácticas de fabricación actuales (cGMP)/21 CFR210-211, los requisitos de la FDA y de la UE, el cumplimiento del USP e ISO; experiencia directa con inspecciones o auditorías regulatorias en persona muy deseadas.
Se especializa en análisis de procesos, desarrollo y mejora.
Experiencia práctica con la biología celular y molecular, así como las técnicas de equipos bioquímicos.
El historial del procesamiento de grandes cantidades de información y datos complejos para proporcionar resúmenes accesibles a otros empleados y gerentes.

CompensaciónEl salario varía dentro de este rango en función de la experiencia, las habilidades, la educación, los certificados y el lugar.

Sobre HemaCare

HemaCare es un líder mundial y una marca de confianza en la personalización de productos biológicos derivados del ser humano y servicios para investigación biomédica, descubrimiento de fármacos y desarrollo de terapia celular y génica.

En enero de 2020, HemaCare fue adquirida por Charles River Laboratories. La cartera combinada crea una solución única e integral para investigadores y desarrolladores y fabricantes de terapia celular en todo el mundo.

Estamos apasionados por mejorar la calidad de vida de las personas.Nuestra misión es proporcionar una cartera de materiales y servicios celulares humanos de alta calidad y personalizables para apoyar el descubrimiento de fármacos, la investigación científica y la terapia celular.

Beneficios

Los beneficios pueden incluir bonificaciones o incentivos basados en el rendimiento, 401 ((k), tiempo libre remunerado, programa de compra de acciones, cobertura de salud y bienestar, programas de apoyo al bienestar del empleado y la familia y flexibilidad en el equilibrio entre trabajo y vida.

Igualdad de oportunidades laborales

Charles River es un empleador de igualdad de oportunidades y se compromete a proporcionar oportunidades de empleo iguales para todos los solicitantes y empleados calificados sin tener en cuenta la raza, el color, el sexo, la religión, el origen nacional, la ascendencia, la edad, discapacidad mental o física, estado familiar, embarazo, estatus militar o veterano, u otra característica protegida por leyes federales, estatales o locales.

En algunos estados (incluyendo Massachusetts) es ilegal exigir o administrar una prueba de detección de mentiras como condición para el empleo o la continuación del trabajo.

Si necesita asistencia especial o un alojamiento debido a una discapacidad para completar cualquier formulario o participar de otra manera en el proceso de presentación del currículum, póngase en contacto con un miembro de nuestro equipo de Recursos Humanos enviando un correo electrónico a crrecruitment_US@crl.com.

Para obtener más información, visite https://www.criver.com y https:// www.hemacare.com.

#J-18808-Ljbffr","

Associate Director, Technical Excellence

Join to apply for the Associate Director, Technical Excellence role at Charles River...","Charles River Laboratories is hiring: Associate Director, Technical Excellence i",[125],["B","2211918885"],"Creative & Design","/jobs/2211918885-charles-river-laboratories-is-hiring-associate-director-technical-excellence-i","Charles River Laboratories is hiring: Associate Director, Technic...","Los Angeles, CA, United States","/jobs?location=Los+Angeles%2C+CA%2C+United+States","/jobs?keyword=Charles+River+Laboratories+is+hiring%3A+Associate+Director%2C+Technic...",{"_65":66,"_67":126,"_69":127,"_71":99,"_73":128},"Los Angeles","Los Angeles, CA, United States, 90079","90079",8752,"name","Newsday Media Group","agency","logo","https://production-rails-default.s3.us-east-2.amazonaws.com/public/legacy-logos/351727.GIF","slug","newsday-media-group","

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