Director - Analytical Lifecycle Strategy - Vaud, Schweiz - Randstad

Beschreibung

For our client specialized in Life Science industryand based in Vaud canton, we're looking for a Director - AnalyticalLifecycle Strategy

Mainstasks

• Development and implementationstrategies to ensure analytical methods remain compliant with MAAs/ BLAs and with evolving regulatoryrequirements.
• Ensure cross-productdeployment of strategy. Collaborate with interdisciplinary teams toprovide strategicanalytical direction andguidance.
• Coordination of a group of subjectmatter experts in charge of product-specific analytical lifecyclemanagement. Mentor and develop staff in their careerpath.
• Represent the group, work with peers andmanager to ensure delivery on the objectives and smoothinteractions within BPD.
• Method transfer:Oversee the effective and compliant transfer of analytical methodsfor release and stability testing between laboratories orsites.
• Routine maintenance and monitoring: Inconjunction with QA / QC departments at site ensure oversight oftrending, review and assessment of the performance of establishedanalytical methods across the DS/DP manufacturingchain.
• Ensure implementation of necessaryadaptations based on product, process or methodchanges.
• Identify method gap and riskassociated with existing / modification of existing methods andtowards implementation of new analyticalmethods.
• Provide expertise in resolvingtechnical issues related to analytical methods, instruments orprocesses.
• Stay updated with regulatoryguidelines and industry best practices.
• Ensureall analytical methodologies meet current pharmacopeial andregulatory requirements. Support filing of dossier variations /updates.
• Draft / review response to queries andobservation from Health Authorities.
• Providesupport during inspections andaudits.
• Participate in analytical deviation andOOx investigation, root cause identification, appropriate CAPA, andCAPA effectiveness check
• Participate in reviewof change control and associated risk and impactassessment
• Ensure maintenance of comprehensivedocumentation of method development, validation, transfer andmonitoring activities.
• Review / approvetechnical studies at internal and various external laboratories.Review / approve stability and comparability protocols andreports.
• Build and sustain strong interfacewith CROs and CMOs critical to the success of product maintenance.Manage project activities, supervise and coordinate varioussponsored / external laboratories.
• Collaboratewith quality and regulatory teams to ensure a holistic approach toproduct life cycle management.
• Provideexpertise and assistance to TechnicalOperations.
• Collaborate with RegulatoryAffairs to ensure alignment with global regulatoryexpectations.

Travel (up to 10%) mayoccur between the different sites

Education

• Master'sdegree in Analytical Chemistry, Pharmaceutical Sciences, or arelated field.
• PhD degree is aplus.

Languages

• Fluencyin English essential, both oral and written to a high professionalstandard; additional languages (French, German,Spanish) are anasset

Workexperience

• Minimum of 10 yearsexperience in pharmaceutical analytical development or a relatedfield in the biopharma industry, essential within thebiotherapeutic field includingantibodies.
• Demonstrated experience inanalytical method development, validation, tech transfer andtroubleshooting in QC environment. In depth experience inanalytical sciences applied to proteins / mAbs and familiar withstate of the art biochemical and biophysical analyticalmethods
• People management experience and/orcompetencies required
• Strong understanding ofglobal pharmaceutical regulations, ICH guidelines and GMPrequirements
• Significant exposure to /understanding of cross-functional CMC development ofbiotherapeutics
• Track record of successfulinteractions with Health Authorities in highly regulatedmarkets
• Demonstrated success operating in aglobal matrix organization with the full breadth of functionscontributing to drugdevelopment