R&d Senior Cmc Associate
hace 3 semanas
Overview:
**mAbxience i**s a global, vertically integrated fully-fledged **biotechnology company,** with over a decade of experience in the development, manufacture and commercialization of biopharmaceutical medicines.
We incorporate the latest state-of-the-art technology in our development and manufacturing platform, across 3 multi product Drug Substance facilities and our partners filling sites.
We are committed to global quality standards to manufacture & supply our products worldwide.
Responsible for leading R&D CMC activities related to product development including demonstration of analytical similarity and comparability, coordinating activities with other R&D functions and project management to deliver activities on time. Provide input to the core team as required to ensure successful products development. Provide support to Regulatory Affairs for scientific advice, RA dossiers creation and updates, and deficiency letters. Suggest and develop teams SOPs. Mentor more junior members of the team.
**Responsibilities**:
- Design strategy for analytical similarity and comparability studies.
- Support analytical characterization studies for CDMO projects.
- Plan and execute studies with support from more junior members and input from other teams as required (e.g. project management): manage CROs, analyze and interpret analytical data, statistical analysis, identify and interpret trends or patterns in complex data sets, identify outliers, request complementary information, and seek clarifications as required. Look for scientific literature to support/illustrate findings.
- Write and review reports with high quality. Ensure data traceability.
- Prepare/review investigators brochures, data packages for scientific advice, regulatory dossiers/variations data packages, and respond to requests from regulatory agencies.
- Collaborate in the improvement of the R&D quality system.
- Actively participate in SOPs development and updates
- Lead/participate in scientific publications.
- Participate in trainings/presentations to other R&D teams or mAbxience departments.
- Mentor more junior members of the team.
Qualifications:
- **Education**: University Degree (Biochemistry, Chemistry, Pharmacy or Biology), PhD is a plus.
- ** Languages**: Fluent English. Spanish desirable
- ** Experience (years/area**)**:> 5 years’ experience in R&D > 2 years’ experience with biosimilars. Experience in QC/QA/Regulatory Affairs under GMP environment is valuable.****:
- **Specific Knowledge**:
- Strong knowledge of the pharmaceutical industry and biosimilars.
- Strong knowledge of physicochemical analytical methods applied to protein/antibody characterization (HCPL based methods, Mass Spectrometry and electrophoretic methods).
- Experience of working with third parties.
- Knowledge of binding assay/bioassays is a plus.
- Practical knowledge/experience as analytical laboratory technician is a plus.
- Experience of working with CDMO companies is a plus.
- Advanced knowledge of Excel including basic statistical analysis.
- Advanced use of Microsoft Word, PowerPoint, and Outlook.
- ** Personal skills**: Ability to lead projects, team player, able to work in multicultural team environment. Strong analytical skills and organization skills. Good attention to detail and accuracy. Disposition to learn.
-
[O285] Senior Associate/ Manager Infraestructuras
hace 2 semanas
Madrid, España Morgan Philips Executive Search A tiempo completoNuestro cliente, equipo líder de Deals de infraestructuras, está buscando un Senior Associate para sus oficinas de Madrid.**Los requisitos para esta posición son las siguientes**:La persona ideal será Licenciado/a en Administración y Dirección de Empresas o similar.Entre 3 años y 6 añosde experiência en estrategia/ Valoraciones/ M&A;/...
-
Senior R&d Engineer F/m
hace 2 semanas
Madrid, España Ansys A tiempo completo**Requisition #**: 13050 When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more than 50 years, Ansys software has enabled innovators across industries to push boundaries by using the predictive power of simulation. From sustainable transportation to...
-
Regulatory Cmc Liaison Manager
hace 6 días
Madrid, España NonStop Consulting A tiempo completoI am actively seeking an experienced RA professional with excellent communication skills and a business mind-set who will provided value-added input to internal stakeholders and clients for a medium-sized pharmaceutical company located in Basel that is growing rapidly. In this exciting and challenging position you will take full responsibility for your...
-
Research and Development Chemist
Encontrado en: beBee S ES - hace 3 semanas
Madrid, España F P Plastics A tiempo completoWe are seeking a Research & Development Technician to join our growing R&D team. This position will focus on working with other R&D staff members to create lab scale and pilot batches of polyurethane adhesives, sealants, elastomer and coatings. The successful candidate will be regularly meet senior R&D staff to obtain projects and to provide updates on...
-
Research and Development Chemist
Encontrado en: beBee jobs ES - hace 2 semanas
Madrid, Madrid, España F P Plastics A tiempo completoWe are seeking a Research & Development Technician to join our growing R&D team. This position will focus on working with other R&D staff members to create lab scale and pilot batches of polyurethane adhesives, sealants, elastomer and coatings. The successful candidate will be regularly meet senior R&D staff to obtain projects and to provide updates on...
-
Manager – R&D Transformation Consulting
hace 6 días
Madrid, España Sdi Digital Group A tiempo completoOverview IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. The team The R&D Transformation consulting team...
-
Cad Senior R&d Engineer F/m
hace 7 días
Madrid, España Ansys A tiempo completo**Requisition #**: 12959 When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more than 50 years, Ansys software has enabled innovators across industries to push boundaries by using the predictive power of simulation. From sustainable transportation to...
-
Delegado/a Comercial Senior
hace 3 semanas
Madrid, España R&S JOBS A tiempo completo**En R&S JOBS seleccionamos para nuestro cliente**: Importante Consultoría energética en expansión. DELEGADO COMERCIAL SENIOR Tareas Se responsabilizará de la información y comercialización de los productos de la compañía en su zona geográfica de influencia mejorando la experiência del cliente, identificando necesidades críticas, y...
-
Manager – R&D Transformation Consulting
Encontrado en: Talent ES C2 - hace 3 semanas
Madrid, España IQVIA A tiempo completoOverview IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. The team The R&D Transformation...
-
Senior Associate Director, Financial Support in Madrid
Encontrado en: beBee jobs ES - hace 1 semana
Madrid, Madrid, España IE University A tiempo completoOverview Senior Associate Director. Financial Support The Financial Support department is looking for a Senior Associate Director. He/She will be responsible for Project Management of VPE & HHRR areas. He/She must have experience in managing Finance & Economics projects.Responsibilities Key Action Areas:Project management: planning, coordinating and...
-
Portfolio Management Senior Associate
hace 4 días
Madrid, España Finsolutia A tiempo completo**_Position:_**_ Portfolio Management Senior Analyst_** At Finsolutia we believe that the key to success is to have the best professionals in our team. For this reason, we are looking for a Senior Associate with 3 to 5 years of experience to join our Portfolio Management Team in Madrid. Thus, we encourage you to sign up and become part of this great...
-
Senior Clinical Research Associate-pasate a Cro
hace 5 días
Madrid, España NonStop Consulting A tiempo completoTengo un par de vacantes como Senior CRA en CRO donde aceptan CRA que no tienen experiência en CRO, este es el rol perfecto para aquellos que estéis trabajando en fundaciones u hospitales y queráis dar el paso e ir a CRO. La empresa ofrece un salario muy competitivo junto con beneficios e incluso una bonificación anual. Buscan a gente para trabajar...
-
Senior Biostatistician- R Programming
hace 3 días
Madrid, España Oracle A tiempo completoSenior Biostatistician - R Programming-2300031X **Applicants are required to read, write, and speak the following languages***: English **Preferred Qualifications** Cerner Enviza is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting...
-
Clinical Research Associate-trabaja en La
hace 7 días
Madrid, España NonStop Consulting A tiempo completoTengo varios puestos como Clinical Research Associate en Madrid en los que no es necesaria experiência en industria o CROs, por tanto, si eres un CRA con al menos 1.5 años de experiência que quiere dar el salto y empezar a trabajar en CROs, con lo que ello conlleva (mejora de condiciones, flexibilidad de poder trabajar desde casa o office based, apoyo...
-
Senior Associate Director, Financial Support in Madrid | Careers at Madrid
Encontrado en: beBee S ES - hace 1 semana
Madrid, España IE University A tiempo completoOverview Senior Associate Director. Financial Support The Financial Support department is looking for a Senior Associate Director. He/She will be responsible for Project Management of VPE & HHRR areas. He/She must have experience in managing Finance & Economics projects. Responsibilities Key Action Areas: Project management: planning, coordinating...
-
Equity Research Associate
hace 22 horas
Madrid, España Jefferies & Company, Inc. A tiempo completo**The Team**: Our sector-based research teams operate with a goal to be our clients’ first call for investment ideas, longer-term thematic pieces and industry expertise. This role sits within the Latin American Research Team, which comprises 4 Senior Analysts and will include a similar number of Associates. The team is highly experienced, and having...
-
Equity Research Associate
hace 22 horas
Madrid, España Jefferies & Company, Inc. A tiempo completo**The Team**: Our sector-based research teams operate with a goal to be our clients’ first call for investment ideas, longer-term thematic pieces and industry expertise. This role sits within the Latin American Research Team, which comprises 4 Senior Analysts and will include a similar number of Associates. The team is highly experienced, and having...
-
Senior Financial Shared Services Associate
Encontrado en: Talent ES C2 - hace 2 semanas
Madrid, España Plug Power A tiempo completoSenior Financial Shared Services Associate - GL Operations Location: Madrid, Spain Status: Exempt (salaried) Department: EMEA Finance/Accounting Position Summary The Senior Associate GL Operations is a critical member of the EMEA FSS Team. This role will help build the team from the ground up, create strong processes and will work across...
-
Senior Clinical Research Associate
Encontrado en: Talent ES C2 - hace 2 semanas
Madrid, España Worldwide Clinical Trials A tiempo completoRequisition Number: 7739 Position Title: Senior Clinical Research Associate External Description: Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications –...
-
Senior Developer R
Encontrado en: beBee S ES - hace 4 semanas
Madrid, España Quental A tiempo completo¿Eres una persona a la que le gustaría afrontar nuevos retos y buscas desarrollar tu carrera profesional en el mundo de los entornos de datos en el área BA, Big Data, en un proyecto referente?¡En Quental tenemos la oportunidad perfecta para ti!Estamos seleccionando para nuestro laboratorio especializado, personas con pasión por la codificación de...