MICROVIABLE THERAPEUTICS

Desarrollando terapias basadas en la microbiota como medicina de precisión

EQUIPO

Hemos construido un equipo sólido y experimentado con líderes en el campo de la microbiota y los probióticos para desarrollar soluciones innovadoras en el ámbito de la salud.

Claudio Hidalgo Cantabrana, PhD

Presidente

Noelia Martínez, PhD

Secretaria

Rafael M. Permuy, MBA

Consejero

Luis Buznego

Consejero

Manuel Monge

Consejero

Luis Prieto Jiménez

Consejero

Mehdi Chouikh Skalli

Consejero

José Vigaray Conde, MD

Consejero

Francisco Morís, PhD

Consejero

Abelardo Margolles, PhD

Co-fundador Científico

Susana Delgado, PhD

Co-fundador Científico

Borja Sánchez, PhD

Co-fundador Científico

Claudio Hidalgo Cantabrana, PhD

Co-fundador Científico y Director General

Rafael M. Permuy, MBA

Co-fundador y Desarrollo de Negocio

Noelia Martínez, PhD

Co-fundador Científico y Directora de I+D

Rosa del Campo, PhD, MD

Asesora científica
Clínica en Hospital Ramón y Cajal, Madrid, España

Carlos López Otín, PhD, MD

Asesor científico
Catedrático de Bioquímica en Universidad de Oviedo, España

Josbert J. Keller, MD, PhD

Asesor científico
Gastroenterólogo en Haaglanden Medisch Centrum. La Haya, Netherlands.

Luis Gosálbez

Luis Gosálbez, PhD, MBA

Asesor de negocio
Director General de Sandwalk BioVentures

Noelia Martínez, PhD

Directora de I+D

David

David Ríos Covián, PhD

Director técnico

Rafael M. Permuy, MBA

Desarrollo de Negocio

Desirée Barrientos

Técnico de laboratorio

Ignacio Alberti

Comercial y desarrollo de negocio

Ignacio Montero, PhD

Biólogo Computacional

Manuel Arenal, MBA

Contabilidad y administración

Marta Fernández Gosende, MS

Personal científico

Pilar Manrique Ronquillo, PhD

Personal científico

Alejandro Ojeda

Alejandro Ojeda Suárez

Técnico de laboratorio

TRABAJA CON NOSOTROS

Equipo sólido, innovador y dinámico

Queremos revolucionar el campo de la microbiota y los probióticos y para eso necesitamos gente inteligente, con alta capacidad de trabajo y dispuesta a unirse a un equipo en continua evolución.

Talento, diversidad e igualdad son los pilares que sostienen nuestras contrataciones y de manera continua buscamos candidatos con perspectiva multidisciplinar, con variedad de perfiles, formación y experiencia.

Job description
We are looking for a full-time, highly motivated individual to work as a Quality Assurance CMO specialist with cGMP experience for novel biotherapeutic products.

About Microviable
Microviable Therapeutics is a preclinical stage biotech company developing a novel class of orally administered biological drugs based on microbiota-derived products. Microviable is developing unique products based on complete microbiota ecosystem products and rationally defined and designed bacterial consortia, to address unmet challenges in human diseases. The current pipeline includes preclinical data for our lead candidate seeking to initiate cGMP manufacturing for first-in-human clinical trials.

Position
We are seeking a Quality Assurance specialist with experience in biological drugs manufacturing at cGMP to assist with the development and implementation of QA documentation in a new facility, monitor QA of the manufacturing process and supervise the already implemented ISO certifications of the company.

Responsibilities

  • Create, review, implement, approve, and maintain QA documentation
  • Provide QA oversight to ensure quality and cGMP compliance of manufacturing process
  • Batch record review and deviation management (creation, review, feedback)
  • Prepare and review API, raw materials, bulk, and finish product release specifications
  • Review and approval of pharma bulk and packaged batch records
  • General compliance activities to support on-site inspections
  • Develop and implementation of CAPA plans
  • Assists in development of appropriate Standard Operating Procedures, laboratory data collection & documentation systems (paper and electronic) and training of personnel to ensure cGMP compliance
  • Support ongoing programs and supervise current ISO certifications
  • Assist the technical team on daily QA items
  • Communicate with the team and ensure QA implementation across the organization and activities

Qualifications

  • More than 3 years of QA experience in a GMP environment in the pharma industry
  • Strong experience on manufacturing and related QA
  • Proven ability to develop and implement QA strategies
  • Experience generating manufacturing documentation and product data sheets
  • Knowledgeable on EU regulations for GMP manufacturing
  • Ability to work independently with minimal supervision.
  • Willingness to work collaboratively in a team environment
  • Highly motivated and organized
  • Fluency in Spanish and English

PROYECTO SUBVENCIONADO

Incentivos a proyectos innovadores 2023

Proyecto «Nuevos Ingredientes Bioactivos para aplicaciones cosmecéuticas» Cofinanciado por el Ayuntamiento de Gijón dentro del programa Incentivos a Proyectos Innovadores 2023 – Plataformas de Cooperación Empresarial.

MICROVIABLE THERAPEUTICS

CONTACTA CON NOSOTROS