MSAT NPI Process Validation PPQ

Toulouse - France

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: MSAT NPI Process Validation PPQ

Location: Toulouse
Department: : MSAT
Reports To: Senior Manager-NPI

Wereexcitedto share thisopportunityispart of the Sandoz acquisition of Just-EvotecBiologicsin Toulouse.Throughthisopportunityyouwillimpact thelivesofhundredsof millions of peoplethroughboldideassupportedby an inclusive agilecompanyculture.Joinus to helpmakehealthcarefairerandfaster help us topioneeraccesstomedicine!

What Youll Do:

Lead Upstream/ Downstream stakeholders for Process Validation at Toulouse to support commercial GMP manufacturing activities.
Acting as a subject matter expert and as a leader for PPQ preparation and execution.
Partner with Product and Process Design Quality CQV and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.
Partner with Product and Process Design and with with Manufacturing to coordinate successful efficient scale-up and technology transfer to ensure the successful integration of process knowledge into manufacturing operations.
Partner with Supply Chain and with Manufacturing to support Bill of Material definition and to develop high-quality batch records innovative and robust processes
Acting as a subject matter expert for regulatory and client inspection audits.
Utilize the teams technical skills and process knowledge to participate and/or lead investigations related to NPI activities. Collaborate with impacted groups to develop and execute effective CAPA.
Apply Operational Excellence principles to lead continuous improvement in NPI activities.

Who You Are:

Ph.D. (or Masters) degree in relevant field or related program with 10 (15) years of pharmaceutical/biotech validation experience including a minimum of 3-5 years of experience leading process validation program PPQ and commercial manufacturing for biopharmaceutical products.
Demonstrated leadership capabilities to build and mentor high-performing multi-disciplinary teams drive change and influence internal and external stakeholders in GMP pharmaceutical or biotechnology
Knowledge of US FDA CFRs and European EMA including ICH guidelines as they relate to drug substance biological manufacturing
Experience in developing submission packages for pharmaceutical product registration
Experience in audits and inspections by health authorities clients and other external auditors as a presenter or audit support staff.
Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.
Technical mastery of cell culture purification and solution preparation operations using disposable-based manufacturing technologies.
Excellent interpersonal team and collaborative skills are required.
Excellent verbal and written communication skills in French and English; ability to interface with all levels of the organization.

WhySandoz

GenericandBiosimilarmedicinesare the backbone of the globalmedicinesindustry. Sandoz a leader in thissectortouchedthelivesofalmost500million patientslast year andwhilewe areproudof thisachievement we have an ambition to domore!

Withinvestmentsin newdevelopmentcapabilities state-of-the-art production sites new acquisitions and partnerships we have theopportunitytoshapethe future of Sandoz and help more patients gainaccessto low-cost high-qualitymedicinessustainably.

Ourmomentumand entrepreneurial spiritispoweredby an open collaborative culturedrivenby ourtalentedandambitiouscolleagueswho in return forapplyingtheirskillsexperiencean agile andcollegiateenvironmentwithimpactful flexible-hybridcareerswherediversityiswelcomedandwherepersonalgrowthisencouraged!

The futureisours toshape!

FR : Dans le cadre de sa politique Diversité Evotec étudie à compétences égales toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy Evotec considers with equal competences all applications including people with disabilities.

Job Title: MSAT NPI Process Validation PPQLocation: ToulouseDepartment: : MSATReports To: Senior Manager-NPIWereexcitedto share thisopportunityispart of the Sandoz acquisition of Just-EvotecBiologicsin Toulouse.Throughthisopportunityyouwillimpact thelivesofhundredsof millions of peoplethroughboldide...