Head of Formulation Development (m/f/d)

Generic drug development

RefNr. 59011/IV |

24.11.2021

Our client is a successful international pharmaceutical company based in Eastern Europe with a leading position in the home market and a constantly growing market share in numerous export markets worldwide. To drive further growth a new EU competence center for pharmaceutical development of generic products based in Vienna will be established. We are looking for an experienced and innovative professional to manage the lab with a team of 10 scientists and engineers.

Arbeitszeit: Vollzeit

Ort: W

Jetzt bewerben

Your Responsibilities

  • Managing the formulation development of laboratory prototypes for complex generics for further industrialization and clinical trials
  • Leading the team of scientists and engineers to ensure the development of the projects
  • In-depth scientific preparation before project approval, including patent search and evaluation, literature survey, data analysis and pre-formulation studies
  • Development of robust, stable and cost-efficient formulations according to Quality by Design principle that aligns with ICH, EU and US pharmaceutical industry regulations and requirements
  • Characterization of drug substances and products including analytical, functional and optionally bioanalytical method development
  • Planning and supervision of scale-up and technology transfer to pilot or industrial plant of the company or CMOs
  • Reviewing and supporting registration dossiers for submission, communication with regulatory authorities
  • Compliance of day-to-day operations with Health Safety and Environment regulations

Your Experiences and Qualifications

  • 8 or more years of experience in Formulation development of a generic company or CDMO
  • Knowledge of ICH standard development, especially in liquid and solid dosage form development
  • Good working knowledge of ICH, US, and/or European drug regulations/guidance, GMP for active pharmaceutical ingredients and generic drugs development/life-cycle
  • Working knowledge of QA and quality management systems in the life science industry (pre-clinical, clinical, CMC during development and commercial operations)
  • Experience with development SOPs/work instructions
  • Demonstration of leadership and management abilities
  • Flexible for business trips, especially to Eastern Europe
  • Excellent English skills are required, German is an advantage

The offer from our client

  • Great opportunity to build up a formulation lab and to support the establishment of a new EU Reseach & Technology Unit
  • Chance to bring in your longstanding experience and know-how in a prosperous company and appreciative environment
  • A robust, reliable and financially strong setting
  • An attractive salary package starting from EUR 85.000,- with a commitment to a higher remuneration depending on skills and previous experiences

Leistungen

BF1 - Gute öffentliche Verkehrsanbindung
BF4 - Home-Office Option
BF5 - Modernes Office bzw. IT Infrastruktur
BF8 - Weiterbildungs- u. entwicklungsmöglichkeiten / Coaching

Monatliche Gehaltsspanne

€ 6.071
Mindestgehalt Überzahlung lt. Qualifikation möglich

Ansprechpartner

Teresa Czernin, MA

Teresa Czernin

Recruiting & Research Specialist

+43 (316) 90 80 10-454

Mag. Sandra Zach-Rabl

Sandra Zach-Rabl

Director Personalberatung, Prokuristin

+43 (316) 90 80 10-456

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