Drug Product Manager* (Reporting to the Vice President CMC & IP)

AiCuris GmbH; Wuppertal; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der Pharmaindustrie sucht einen engagierten Drug Product Manager, der Teil eines dynamischen CMC-Managementteams wird. In dieser spannenden Rolle sind Sie verantwortlich für die Verwaltung der klinischen und kommerziellen Arzneimittelversorgung, die Sicherstellung der Produktqualität sowie die Zusammenarbeit mit externen Partnern. Sie werden an innovativen Projekten arbeiten, die darauf abzielen, das Leben von Patienten zu verbessern, und haben die Möglichkeit, sich in einem unterstützenden und flexiblen Arbeitsumfeld weiterzuentwickeln. Wenn Sie eine Leidenschaft für wissenschaftliche Exzellenz haben und in einem kollaborativen Team arbeiten möchten, könnte dies die perfekte Gelegenheit für Sie sein.

Leistungen

Arbeitgeberfinanzierte Altersvorsorge

Attraktives Leistungspaket

Flexible Arbeitszeiten

Individuelle Entwicklungsmöglichkeiten

Qualifikationen

• Mindestens 5 Jahre Erfahrung in der pharmazeutischen/biotechnologischen Industrie.
• Erfahrung in der CMO/CDMO/CRO Verwaltung und Zusammenarbeit mit externen Partnern.

Aufgaben

• Management von CMO/CDMO/CRO für pharmazeutische Entwicklung und Herstellung.
• Koordination von Pre-Formulierungs- und Kompatibilitätsstudien.

Kenntnisse

Pharmazeutische Entwicklung

CMC Projektmanagement

GMP-Compliance

Analytik

Regulatorische Einreichungen

Kommunikationsfähigkeiten

Ausbildung

PhD in Chemie oder Pharmatechnologie

Jobbeschreibung

Your mission

As a Drug Product Manager* you will be part of our CMC management team supporting all development projects with respect to managing clinical and commercial drug supply, ensuring product quality, managing CMOs/ CDMOs/ CROs, and preparing CMC documentation for regulatory dossiers.

Responsibilities

• CMO/ CDMO/ CRO management for pharmaceutical development and drug product manufacturing for clinical study supply and early commercial phases
• Management of all aspects of technical drug product development (eg, analytics, galenic forms and compositions, in particular: solid and i.v. formulations)
• Coordination of pre-formulation and compatibility studies within the formulation development
• Collaboration with clinical development teams to give advice on quality aspects and clinical supplies handling
• CMC project management, including clinical supply demand and timeline planning and representation of CMC in project teams
• Selection and evaluation of suitable CMOs/ CDMOs/ CROs for GMP manufacture and testing
• Cost of good assessment, support of commercial phase preparation, and post-approval activities
• Support of regulatory fillings in US and EU (eg, CTD module 3) and review of quality documentation relevant for manufacturing and testing (eg, MBR, validation protocols)
• Close interaction with QA/QC to manage CAPAs, change controls, quality incidents and participating in audits as technical expert

Your profile

• PhD (or equivalent) in Chemistry or Pharmaceutical Technology or similar
• At least 5 years of professional experience in the pharmaceutical / biotech industry
• Profound experience in CMC development for early- and late-phase programs, specifically with drug product related activities
• Experience in CMO/CDMO/CRO management and collaboration with external partners
• Experience with supporting regulatory filings in US and EU
• Sound expertise in GMP-compliant drug product manufacturing and testing, including validation and transfer
• Ability to efficiently evaluate, prioritize and handle multiple project tasks
• Highly motivated and ability to work independently as well as in the team
• Excellent organizational and communication skills
• Business fluent in English; German skills would be beneficial

Why us?

• Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration.
• Development:We encourage people to grow and strongly support individual development and learning opportunities.
• Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life.
• Benefits: Employer-funded pension comes along with an attractive benefits package