07.05.2020

CMC Expert, Biologicals (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 

CMC Expert, Biologicals (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 CMC activities (outsourcing) for all the AiCuris biological development projects.

Responsibilities

  • To support development and subsequent manufacturing of biological processes from cell line development through upstream and downstream processing
  • Conceptualize and lead early and late stage formulation development (liquid, lyophilized, high concentration etc.) for macromolecules (Proteins and antibodies)
  • Develop and optimize processes for drug substance
  • Manage activities relevant to drug product development (mixing studies, filtration studies, extractable/leachable studies etc.)
  • Responsible for technology transfer from the early stage CROs  to late stage CMOs during different phases of product development
  • Actively contribute to relevant part of CTD section 3 of IND/IMPD’s.
  • Interpret and report results of work carried out in written and verbal format performed with  external partners
  • Evaluate external developments in the area of drug substance manufacturing and formulation development

 

Requirements

  • PhD in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 3-5 years of industrial experience or MSc or equivalent in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 8 years industrial experience
  • Significant experience in protein/monoclonal antibodies/bispecifics formulation for both early and late phase development
  • Experience in process development related to drug substance and drug products (lyophilization) manufacturing
  • Knowledge of technology transfer and regulatory submissions in USA/EU for sections relevant to drug product development/manufacturing
  • Exposure to the principles of QBD (Quality By Design) and DOE (Design of Experiment)
  • Ability to manage development and manufacturing with external partners
  • Experience in regulatory relationships (scientific advices)
  • Fluency in English, both written and verbal
  • Excellent communication skills and strong diplomacy skills required

 

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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