Introduction

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2’600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

To strengthen our Global team in Basel (CH) or Plankstadt (Germany) we are looking as soon as possible for an

Global Head of Toxicology (m/f/d)

  • Plankstadt
  • asap
  • Full-time
  • Permanent

Main activities and responsibilities

  • Provide occupational and environmental toxicology guidance to CordenPharma facilities in  Europe involved in the manufacture and handling of potent new chemical entities, pharmaceutical compounds and toxic materials. Develop occupational toxicology documents and product safety documents including: occupational exposure limits (OELs, long time and short time), PDE Limits, acceptable surface limits (ASLs), hazard categorizations, safety data sheets (SDSs) and related regulatory hazard communication documents and acceptable daily exposures (ADEs) in according to national and international guidlines. Perform computational analysis on impurities and raw materials to evaluate genotoxicity potential as per ICH / EMA / CHMP / SWP / CHMP / CVMP guidelines.
  • Conduct toxicological hazard assessments for drug development programs for worker safety to support generation of OELs and PDEs by critically evaluating clinical and non-clinical data from study reports, published literature, and benchmark data.
  • Categorize active pharmaceutical ingredients for occupational health purposes based on toxicity and potency according to established criteria; provide recommended handling practices for these compounds for laboratory, Pilot Plant and production settings
  • Review and summarize scientific literature and study reports from various analytical and toxicological testing. Integrate data from toxicologica studies and provide an assessment of the possible physiologic/toxicologic outcomes.
  • Experience conducting/interpreting in silico analysis (e.g Leadscope Model Applier, DEREK) is desirable.

Your Profile

  • Master's degree (Ph.D. preferred) in Chemistry, Pharmacy, Medicine, Biology or equivalent with extensive experience in the chemical/pharmaceutical industry with a focus on toxicology.
  • At least 5 to 10 years of relevant work experience.
  • Good knowledge of German and English.
  • Skilled in administrative tasks, standard documentation, basic knowledge of Finance.

What we offer

  30 days of vacation

  Dynamic and exciting work environment

  Positive working atmosphere and open management culture with focus on continuous improvement of processes to stay innovative

  Free Parking

  Subsidy for fitness studio

Interested?

If you enjoy working in a team and are interested in a varied area of responsibility, if you think and act beyond your own area of responsibility, then you should join our team.

Do you require more information?

In case of questions to your application, the position or something else I am very happy to support you. 

Karlheinz Kelsch
Global HR Business Partner