07.05.2020

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

(in Full-time) (unlimited contract)

Committed to making the difference

AiCuris – founded in 2006 – is a specialist for infectious diseases. Its focus comprises discovery, research and development of novel antiviral and antibacterial agents in the indications human cytomegalovirus, herpes simplex virus, hepatitis B virus, adenovirus, and (multi-)resistant bacterial infections treated in the hospital. With its highly innovative pipeline, AiCuris addresses specialist markets and severe, potentially life-threatening infections with high medical need. Major steps for the company were signing a license agreement with Merck & Co. (MSD) and the marketing authorization for Prevymis™ (Letermovir) in the US and Europe.

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

Interested to join our team? Then apply online (click here ). If you have any questions, please do not hesitate to contact us at +49 202 317 63 2599.

 

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

 

Contact details:

AiCuris Anti-infective Cures GmbH
Daniela Boshoven
Friedrich-Ebert-Str. 475
Gebäude 302
DE-42117 Wuppertal

Tel.: +49 202 317 63 2599
Web: www.aicuris.com 

 


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