General responsabilities:
This individual will be responsible for the development, qualification and eventual validation of new analytical methods, co-ordination of sample testing to support process development and other developments activities at all stages of development.
Review and familiarization of external analytical data packages provided by customers.
The analytical techniques include, but are not limited to: reverse and normal phase (U)HPLC-UV, GC-FID, LC-MS, GC-MS etc. that may be applied for comprehensive understanding of drug substance development, análisis and control.
This individual will be required to present and interpret scientific data, write technical reports and represent the Analytical Development team in matrix team or R&D group meetings when needed.
Specific Responsibility:
Laboratory work as Analyst within the Analytical development department.
Performs the assigned analytical tasks individually in support of process development, registration, lot release, pre and post regulatory submission activities.
Performs activities within the assigned timelines and in compliance with cGXP’s, regulatory requirements and company practices and procedures.
Development, qualification and validation of new analytical methods. Identifies technical challenges during analytical method development and perform method trouble shooting.
Proactively participates in activities in support of process development
Communicates effectively with peers, supervisor and management about the status of the assigned activities.
Write and review technical and data analysis reports, SOPs, Tech Transfer documents and maintain accurate, precise, legible documentations when required.
Experience and personal skills:
Education: Preferably holds a degree in chemistry, analytical chemistry or other related disciplines preferred.
Languages: Excellent communication and interpersonal skills in English and Spanish, both written and verbal are required. (Spanish is not a must).
Experience: Minimum of 2-3 years within Analytical Development laboratory, experience in QC laboratories will also be valuable
Hands-on experience and expertise in analytical methods such as (U)HPLC-UV, GC-FID, LC-MS, GC-MS and other related drug substance characterization techniques.
Basic Information on Data Protection
In compliance with Organic Law 3/2018 of 5 December on the Protection of Personal Data and Guarantee of Digital Rights and Regulation (EU) 2016/679 on the protection of individuals with regard to the processing of personal data and the free circulation of these data, FARMHISPANIA, S.A., ROLABO OUTSOURCING, S.L. and FARMHISPANIA GROUP, S.L. inform you that your data will be incorporated into a register of processing activities of which they are co-owners and co-responsible in order to meet your request. The CVs received will be incorporated into the register of processing activities called “SELECTION OF STAFF” for the purpose of evaluating potential candidates for current or future jobs in the company and to carry out personnel selection processes.
You have the right to access, rectify, limit, oppose, take and delete the data, as well as other rights, indicated in the additional information, which can be exercised by contacting the postal address of the person responsible indicated below or by means of the email dpo@fhrt.com You can consult additional and detailed information on the treatment of your data in the Privacy Policy of our web page or requesting it from the HR department of Passeig Del Riu Besòs 9-10, Montmeló (08160), Barcelona.
Información básica sobre protección de datos
En cumplimiento de la Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y Garantía de los Derechos Digitales y el Reglamento (UE) 2016/679 relativo a la protección de las personas físicas en lo que respecta al tratamiento de datos personales y a la libre circulación de estos datos, FARMHISPANIA, S.A., ROLABO OUTSOURCING, S.L. y FARMHISPANIA GROUP, S.L. le informan de que sus datos serán incorporados a un registro de actividades del tratamiento del que son cotitulares y corresponsables con la finalidad de atender su solicitud. Los CV recibidos se incorporarán al registro de actividades del tratamiento denominado “SELECCION DE PERSONAL” con el objetivo de evaluar posibles candidatos para trabajos actuales o futuros en la empresa y realizar los procesos de selección de personal.
Tiene derecho a acceder, rectificar, limitar, oponerse, portar y suprimir los datos, así como otros derechos, indicados en la información adicional, que puede ejercer dirigiéndose a la dirección postal del responsable indicada más abajo o mediante el correo electrónico dpo@fhrt.com. Puede consultar información adicional y detallada sobre el tratamiento de sus datos en la Política de Privacidad de nuestra página web o solicitándola al departamento de RRHH de Passeig Del Riu Besòs 9-10, Montmeló (08160), Barcelona.
