Drug Substance Manager*

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Overview

As a Drug Substance 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 API manufacturing of small molecules and Tides (mainly Oligonucleotides) for clinical study supply and early commercial phases
• Management of all aspects of technical drug substance development (e.g., analytics, solid state assessment, impurity profiling, route finding)
• Close interaction with QA/QC to manage CAPAs, change controls, quality incidents, writing of SOPs and participating in audits as technical expert
• Supply chain management of APIs, Regulatory Starting Materials, and other critical reagents
• Support of 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 filings in US and EU (e.g., CTD module 3) and review of quality documentation relevant for manufacturing and testing (e.g., MBR, validation protocols)

Your profile

• PhD (or equivalent) in Chemistry or Pharmaceutical Technology or similar
• At least 5 years of post-graduate professional experience in the pharmaceutical/biotech industry
• Profound experience in CMC development for early- and late-phase programs, specifically with drug substance related activities
• Exposure to the principles of QbD (Quality by Design) and DoE (Design of Experiment)
• 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 substance 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. You can work with innovation-awarded experts who translate science into commercial success, with diversity, inspiration and trustful collaboration.
• Development: We encourage people to grow and strongly support individual development and learning opportunities.
• Flexibility: We enable our people to integrate business into their personal life.
• Benefits: Employer-funded pension along with an attractive benefits package

About us

AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS, is marketed by our partner MSD, and our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad patient population. AiCuris is committed to providing therapeutic solutions now and in the future.

We hire people who are collaborative, adaptable, communicate well, and love to learn. AiCuris is an equal opportunity employer that supports diversity and inclusion. We welcome applications from people regardless of national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity or other legally protected characteristics.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Science and Research

Industries

• Biopharma and Healthcare

Cologne, North Rhine-Westphalia, Germany