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.
- 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
- 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?
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
Friedrich-Ebert-Str. 475 / Build. 302