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

AiCuris GmbH; Wuppertal; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Wuppertal seeks a Drug Product Manager to oversee development projects related to drug supply. The ideal candidate will have a PhD in Chemistry or similar, 5+ years of experience in pharmaceutical development, and strong GMP expertise. This role offers opportunities for personal growth, flexible working arrangements, and attractive benefits including an employer-funded pension.

Leistungen

Unique company culture

Personal growth opportunities

Flexible working arrangements

Employer-funded pension

Qualifikationen

• Minimum of 5 years post-graduate experience in pharmaceutical/biotech industry.
• Extensive experience in CMC development for drug product activities.
• Knowledge of QbD and DoE principles.

Aufgaben

• Manage CMO / CDMO / CRO relationships for drug product manufacturing.
• Oversee technical drug product development, including analytics.
• Support regulatory filings in the US and EU.

Kenntnisse

Pharmaceutical development

Project management

Regulatory knowledge (US/EU)

Strong GMP expertise

Communication skills

Fluent English

Ausbildung

PhD in Chemistry or related field

Jobbeschreibung

Your mission

As a Drug Product Manager

• Support all development projects related to clinical and commercial drug supply, ensuring product quality, managing CMOs / CDMOs / CROs, and preparing CMC documentation for regulatory dossiers.

Responsibilities

• Manage CMO / CDMO / CRO relationships for pharmaceutical development and drug product manufacturing for clinical and early commercial phases.
• Oversee technical drug product development, including analytics, galenic forms, and formulations (solid and i.v.).
• Coordinate with QA / QC to manage CAPAs, change controls, quality incidents, SOP writing, and audits as a technical expert.
• Lead pre-formulation and compatibility studies within formulation development.
• Collaborate with clinical teams on quality aspects and clinical supplies handling.
• Support the selection and evaluation of CMOs / CDMOs / CROs for GMP manufacturing and testing.
• Assist in regulatory filings in the US and EU (e.g., CTD module 3) and review relevant quality documentation.

Your profile

• PhD (or equivalent) in Chemistry, Pharmaceutical Technology, or related field.
• Minimum of 5 years post-graduate experience in the pharmaceutical/biotech industry.
• Extensive experience in CMC development for various phases, focusing on drug product activities.
• Knowledge of QbD and DoE principles.
• Experience managing external partners like CMO / CDMO / CRO.
• Experience supporting US and EU regulatory filings.
• Strong GMP expertise in drug manufacturing and testing, including validation and transfer.
• Ability to manage multiple projects efficiently.
• Motivated, independent, and team-oriented.
• Excellent organizational and communication skills.
• Fluent in English; German skills are a plus.

Why us?

• Unique culture emphasizing scientific excellence, collaboration, and patient impact.
• Opportunities for personal growth and development.
• Flexible working arrangements.
• Attractive benefits, including employer-funded pension.