Employment Type: Permanent position

Career Level:

Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.

With over 1600 employees, the Octapharma site in Vienna is the largest production site, and successful research and development location.

Your main tasks and responsibilities

• Design and external outsourcing of pharmacological/toxicological studies
• Monitoring and evaluation of pharmacological/toxicological studies
• Preparation of regulatory documents, including Modules 2.4 and 2.6 of the Common Technical Document (eCTD), Environmental Risk Assessment, and responses to health authority inquiries
• Conduct Toxicological testing methods and Toxicological Risk Assessment (impurities, excipients, extractables & leachables)
• Providing advisory services and collaborate cross-functionally with internal teams and external partners to support product development and global regulator strategies
  

Your expertise and ideal skill set

• Completed degree (Master, PhD) in Life Sciences, Biology, Veterinary medicine, Chemistry, or a related discipline; additional qualification in Toxicology preferred
• First experience in the pharmaceutical industry, with a focus on preclinical product development and/or toxicological risk assessment, expertise in toxicological testing methods
• Familiarity with regulatory requirements (ICH, FDA, EMA) and knowledge of GLP guidelines
• Hands-on experience with regulatory authorities and expertise in medical writing
• Proficiency in MS Office 365 and ability to work with digital tools effectively
• Excellent communication skills in German and English (written and spoken)
• Strong organizational and interpersonal skills, combined with a proactive, results-driven mindset and exceptional problem-solving and critical-thinking abilities
• Willingness to travel, primarily within Europe

Your department - where you make an impact

• We, the Pharmacology & Toxicology (P&T) Department, manage all pharmacological and toxicological aspects of Octapharma products.
• We conduct preclinical research and perform toxicological risk assessments to ensure product safety and efficacy throughout the entire life cycle. Our mission is simple: to improve patient health and safety.