07.05.2020

GMP Development and Manufacture of APIs Expert (small molecules) (m/f/d)

(in Full-time) (unlimited contract)

The Powerhouse for Anti-infectives –
Committed to making the difference

 

AiCuris is a pharmaceutical company specializing in the discovery, research, and development of novel, resistance‐breaking antiviral and antibacterial agents for the treatment of serious and potentially life-threatening infectious diseases. Founded in 2006 as a spin‐out from Bayer Infection Research, AiCuris today manages an innovative pipeline of anti-infective agents with a team of internationally recognized scientists in Research and Development. We are one of the few European biotech companies which has brought a drug with “block buster” potential to the market (Prevymis® 2017/18).

 

AiCuris is offering the position of a: 

GMP Development and Manufacture of APIs Expert (small molecules) (m/f/d) 

(in full time)


Reporting to the Head of Chemistry, Pharmaceutical Development and Patent Affairs

 

In this role you will be responsible for the co-ordination of all GMP-related internal and external CMC formulation activities for all the AiCuris small molecule research and development projects.

 

Responsibilities

 
  • Route-finding and process development activities with external partners
  • Support of internal project teams in the candidate selection phase
  • Selection and evaluation of suitable GMP CROs
  • Supervising external CROs during the GMP manufacturing phase for clinical study supply and early commercial phases
  • Specific experience in impurity profiling and assessment
  • Documentation and quality control of all dossier-relevant reports (external and internal ones) including Master Batch records and Analytical Validation Protocols and Reports
  • Supervising the preparation of regulatory documents (IMPDs, CTD Module 3 documentation for drug substance, support IP preparation)
  • Organizing and conduct of GMP audits
  • Close interaction with QA/QC and regulatory department to follow up CAPAs, change controls and any other related activities in the drug substance manufacturing process
  • Update of all relevant internal SOPs and preparation of new SOPs for further quality improvement
  • Support of QP release

 

Requirements

 
  • PhD (or other adequate title) in Chemistry or other adequate title
  • 5-8 years proven experience in her/his area of responsibility with specific focus on process development and GMP manufacturing
  • Broad experience in route scouting and proven records in process development with additional experience in green chemistry trends
  • State of the art knowledge in industrial process chemistry (modern and scalable synthesis experience)
  • Leadership skills leading a team of at least 2-5 people
  • Experience in different regulatory areas: EMA, FDA and cFDA
  • Regulatory experience with proven record in Quality Control activities
  • Experience in CTD Module 3 writing for EMA, FDA and cFDA submission
  • Sound expertise in route finding, process development, GMP manufacturing for clinical study supply and early commercial phase, analytical method development and validation is essential
  • Ability to efficiently evaluate, prioritize and handle multiple project tasks
  • Experience in managing alliances with international external partners
  • Highly motivated, able to work independently and in a team
  • Ability to lead larger (project) teams having sole responsibility
  • Ability to think strategically about projects and business issues
  • Strong analytical and project management skills
  • Business fluent in English; German skills would be beneficial

 

What we can offer

 
  • Cooperation in multinational and interdisciplinary teams
  • An exciting and challenging job in a promising research and development company with an excellent R&D portfolio
  • Flexible working hours and self-determined time management
  • Regular and targeted further training and individual development opportunities
  • Attractive company pension scheme
  • A wide range of services relating to health and reconciling work and family life

 

How to apply

You can find a PDF of the job description here.
 
Interested to join our team?
Then apply online (click here ).
If you have any questions, please do not hesitate to contact us at +49 (0)202 317 63 - 0.
 

 

Note for headhunters: We are not interested in support. Thanks!

 

AiCuris Anti-infective Cures AG

Human Resources
Anna Frey
Friedrich-Ebert-Str. 475 / Build. 302
42117 Wuppertal
Germany

www.aicuris.com

 


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