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

Permanent employee, Full-time · Hybrid

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

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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, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.

Passionate about our mission to develop anti-infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other's personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.

*AiCuris is an employer that supports equal opportunities, diversity and inclusion. We welcome applications from people regardless of their national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity or other legally protected characteristics.

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Your application!

We appreciate your interest in our company. Please fill in the following short form. Should you have any difficulties in uploading your files, please contact us by mail at jobs@Aicuris.com.