05 ago
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Talent
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San Cugat del Vallés
05 ago
Talent
San Cugat del Vallés
MissionEnvíe su solicitud a continuación después de leer todos los detalles y la información de apoyo sobre esta ocasión de trabajo.The Analytical Development Scientist will be responsible for leading the development, validation, and transfer of analytical methods to ensure the quality, robustnessn and regulatory compliance of pharmaceutical products throughout their lifecycle. This role acts as a key analytical reference within cross-functional project teams, supporting product development from early stages through GMP manufacturing and regulatory submission.ResponsibilitiesLead the development and optimization of analytical methods, primarily using chromatographic techniques (HPLC, UPLC), providing technical guidance and support to analytical teams.Validate analytical methods in compliance with ICH guidelines (Q2(R2), Q14).Manage and support analytical method transfers to internal and external laboratoris, including deviation investigation and resolution.Coordinate and manage stability studies, ensuring appropriate planning, execution, data evaluation, and documentation.Perform analytical troubleshooting during development, validation, release testing, and stability studies.Analyze and interpret analytical data applying statistical tools and Quality by Design (QbD) principles to analytical methods.Prepare, review, and approve technical documentation, including development and validation protocols and reports, transfer documentation, SOPs, and risk assessments in accordance with ICH Q9.Operate in a GMP environment, ensuring compliance with international regulatory requirements (EMA, FDA) and managing activities within the Quality Management System (changes, deviations, CAPAs).Provide analytical support to regulatory activities, including dossier preparation, change controls,
and responses to health authorities.Drive continuous improvement initiatives within the analytical development area to enhance efficiency and performance.Collaborate closely with Formulation Development, QA, QC, Manufacturing, and Regulatory Affairs, assuming analytical leadership within cross-functional project teams.Manage and prioritize multiple projects simultaneously, ensuring timelines are met with high technical rigor.Why Ferrer?Make a positive impact in societyParticipate in volunteering activitiesGrow in a culture of trust, responsibility, and constructive feedbackEnjoy a flexible working model & collaborative office experience to enable innovation and teamworkMake a real difference to the team and to yourselfTake advantage of opportunities for development & learningDiscover a range of benefits to support your physical, emotional and financial wellbeingCustomize your remuneration and benefitWhat You’ll Need To SucceedYou will rock at this company if you are a person with empathy, humility, curiosity and optimism. You will rock at this role if you match with:Degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline.Minimum B2 level of English; C1 is highly desirable.Extensive senior- level experience in Analytical Development within the pharmaceutical industry, acting as a subject matter expert in analytical method development.Strong expertise in chromatographic method development, particularly HPLC and UPLC.Experience with HPLC-MS is highly valued.Strong autonomy, critical thinking, and decision-making skills.Proven ability to organize, prioritize, and manage multiple projects in parallel.Excellent written and verbal communication skills in multidisciplinary and international environments.Ability to scientifically justify analytical results and defend technical decisions.Strong team-oriented mindset, contributing proactively to shared objectives. xcskxlj At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.#J-18808-Ljbffr
📌 ANALYTICAL DEVELOPMENT SCIENTIST (San Cugat del Vallés)
🏢 Talent
📍 San Cugat del Vallés