Analytical Development Senior Scientist

Actual Talent; Laza; Presencial; EUR 52.000 - 72.000; Jornada completa

Descripción de la vacante

Actual Talent is seeking an Analytical Development Senior Scientist for a leading European CNS-focused pharmaceutical company. You will design, develop, organize, perform, review, evaluate and report analytical tests per GxP and ICH guidelines, ensuring reliable data for regulatory submissions and product approvals.

You will lead development studies, validations, and stability assessments, write SOPs, contribute to Registration Dossier sections, and maintain instruments.

Formación

• 3+ years developing analytical functions in pharma under EU GMP.
• Experience with HPLC, GC, and ICP-MS analytical techniques.
• Degree in chemical or pharmaceutical sciences.

Responsabilidades

• Distribute, review, analyze and report results from projects to meet deadlines.
• Develop, verify and/or validate analytical methods.
• Work independently in a fast-paced, changing environment, reporting to the team lead.
• Write and/or review SOPs and other analytical validation documents.
• Prepare sections of Module III of the Registration Dossier with Galenical scientists.
• Ensure calibration and maintenance of analytical instruments and equipment.
• Represent the Analysis Section in project team meetings.

Conocimientos

Analytical method development

Regulatory compliance (GxP)

Data analysis

Educación

Degree in chemical or pharmaceutical sciences

Herramientas

HPLC

GC

ICP-MS

Descripción del empleo

Actual Talent is a talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.

Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.

About the client:

We are working with a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders that is currently seeking an Analytical Development Senior Scientist.

Your Mission:

Design, develop, organize, perform , review, evaluate and report any analytical test according to the established quad guidelines (GxP, ICH, etc.) and following the corresponding SOP to ensure reliability and quality data for the regulation and marketing of new pharmaceutical drug products.

Your Major Accountabilities:

• Distribute, review, analyze and report all the results obtained of the assigned projects to accomplish the deadline (development studies, validations, stability studies, etc.) agree with the project team.
• Develop, verify and/or validate the required analytical methods.
• Work effectively independently being able to adapt to fast pace rapidly changing environment, reporting to the team leader.
• Write and/or review SOP's and other relevant documents as analytical validation report.
• Write different sections of Module III of the Registration Dossier in collaboration with Galenical scientist.
• Assure the correct calibration and maintenance of the assigned instruments and equipment.
• Represent the Analysis Section in the meetings of the project team s assigned.

We Would Like You To Have:

• At least 3 years developing similar functions to those described in Major Accountabilities in pharmaceutical industry working to EU GMP standards.
• Educational background in analytical techniques: HPLC. GC, ICP. MS IFL etc.
• User-level computers tools
• Risk assessment knowledge
• Degree In chemical or pharmaceutical sciences