Biopharmaceuticals – Preclinical Toxicologist (m/w/d)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 270449BR


Stellenbeschreibung

8 biosimilars across immunology, oncology and endocrinology are already on the market, Sandoz Biopharmaceuticals has a leading biosimilars pipeline with additional molecules in various stages of development. As Preclinical Toxicologist you contribute to the future success of our biosimilars development and you are responsible for safety relevant aspects related to e.g. excipients, impurities, particles and leachables/extractables. In addition, you provide nonclinical expertise to assigned biosimilar program teams and lead the timely planning of the nonclinical development programs.

Your responsibilities:

The Preclinical Toxicologist supports all international Biopharma development teams with respect to safety relevant aspects related to e.g. excipients, impurities, particles and leachables/extractables. In addition, he is/she provides nonclinical expertise to assigned biosimilar program teams and leads the timely planning of the nonclinical development programs.

• Is the primary toxicological contact and interface and independently works with all Biopharma project teams from project approval to post-marketing pharmacovigilance to identify and define safety risks, prepare or coordinate toxicology assessments, perform data-based decision making, and support regulatory submissions

• Sets up and leads the execution of the nonclinical in vivo toxicology studies, if required

• Independently leads the interface between the Biopharmaceuticals Preclinical Development and other Sandoz line-functions, as well as Preclinical Safety (PCS) in NIBR, with regard to toxicology and general safety topics

• Leads the generation of nonclinical documents with regards to safety and compiles nonclinical documentation for regulatory dossiers incl. answers to health authority questions
• Is the contact person for toxicological questions during submissions to obtain market authorizations for Sandoz Biopharma products

• Is, in addition, the Preclinical Development representative in global cross-functional and clinical project teams and provides general nonclinical expertise to assigned biosimilar programs from early strategic planning to post-approval in close collaboration with Analytical Characterization, Clinical Development, Medical Affairs and New Products and Strategy
• Sets up and leads the timely, quality planning and execution of the nonclinical development programs which includes a thorough assessment of the requirement for animal studies according to guidelines and 3R principles using a step-wise approach (in silico knowledge-based, in vitro, in vivo)
• Interprets the nonclinical in vitro and in vivo pharmacology and safety data, including decision analysis, regulatory acceptability and issue resolution and translates nonclinical study data into clinical strategy and study design
• Provides pharmacology expertise for in vitro functional characterization and bioassay strategy and ensures an integrated assessment of nonclinical and in vitro bioassay data
• Assures quality of studies and study results according to the appropriate SOPs, GLP and other guidelines/regulations in compliance with Sandoz/Novartis guidelines.

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Research & Development


Mindestanforderungen

What you’ll bring to the role:

• Doctoral degree in biological / life sciences, certified toxicologist preferred
• Excellent communication skills in English, knowledge of German a plus
• 8+ years of previous industry experience in biotherapeutic drug development in a global matrix environment and in toxicological assessments
• 5+ years or equivalent multi-/cross-functional team experience
• Excellent knowledge of current literature, regulatory guidelines, concepts and controversies in nonclinical pharmacology and safety
• Knowledge of innovative nonclinical study design (in vitro, in vivo), statistics and pharmacokinetics
• Experience in the development of monoclonal antibodies is preferred
• Experience as company representative during interactions with regulatory authorities


Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Join us, and help reimagine access to medicine.


Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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