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.
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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.
Responsibilities
Leadthedevelopmentandoptimizationofanalyticalmethods,primarilyusingchromatographictechniques(HPLC, UPLC),providingtechnicalguidanceandsupporttoanalyticalteams.
ValidateanalyticalmethodsincompliancewithICHguidelines(Q2(R2), Q14).
Manage and support analytical method transfers to internal and external laboratoris, including deviation investigation and resolution.
Coordinateandmanagestabilitystudies,ensuringappropriateplanning,execution, dataevaluation, anddocumentation.
Performanalyticaltroubleshootingduringdevelopment,validation,releasetesting, andstabilitystudies.
AnalyzeandinterpretanalyticaldataapplyingstatisticaltoolsandQualitybyDesign(QbD)principlestoanalyticalmethods.
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.
Drivecontinuousimprovementinitiativeswithintheanalyticaldevelopmentareatoenhanceefficiencyand 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.
Benefits
Make a positive impact in society
Grow in a culture of trust, responsibility, and constructive feedback
Enjoy a adaptable working model & collaborative office experience to enable innovation and teamworking
Make a real difference to the team and to yourself
Take advantage of opportunities for development & learning
Discover a range of benefits to support your physical, emotional and financial wellbeing
Customize your remuneration and benefit
Requirements
What you’ll need to succeed
You 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:
DegreeinChemistry,Biochemistry,Pharmacy,orarelatedscientificdiscipline.
MinimumB2levelofEnglish;
C1ishighlydesirable.I>
Extensive senior- level experience in Analytical Development within the pharmaceutical industry, acting as a subject matter expert in analytical method development.
Strongexpertiseinchromatographicmethoddevelopment,particularlyHPLC and UPLC.
ExperiencewithHPLC-MSishighlyvalued.
Strongautonomy,criticalthinking, anddecision-makingskills.
Provenabilitytoorganize,prioritize, andmanagemultipleprojectsinparallel.
Excellent written and verbal communication skills in multidisciplinary and international environments.
Abilitytoscientificallyjustifyanalyticalresultsanddefendtechnicaldecisions.
Strongteam-orientedmindset,contributingproactivelytosharedobjectives. xhfqzwm
If this great challenge matches your profile, then we are waiting for you!
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.
Sector: Pharmaceutical and biopharmaceutical
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