Toxicology Expert, Biologics

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Granite Bio AG Vollzeit

GRANITE BIO is seeking a (Senior) Toxicology Expert, Biologics / Project in Immunology.

GRANITE BIO is a recently established biotechnology company in the Ridgeline Discovery incubator located in Basel (Switzerland). Based on fundamental research over the last two decades, GRANITE BIO's differentiated approach is to impact central disease biology nodes to transform inflammatory, autoimmune and fibrotic conditions. The lead therapeutic antibody received clinical trial approval by competent health authorities to initiate Ph1(b) trial in Q1/2024.

We are seeking a highly motivated and experienced Toxicologist Expert forBiologics human therapeutics to join our team. The successful candidate will play a critical role in advancing our biologics projects in immunology from preclinical to clinical stages.

RESPONSIBILITIES

  • Plan and execute (chronic) toxicology studies non-human primates to support Ph2 clinical development of our biologic project in immunology after both IV and SC administrations.
  • Develop a tailored toxicology strategy for antibody pre-clinical programs to enable IND/CTA and later clinical development until launch including special cases such as in vitro-only safety testing strategies.
  • Interpret and integrate in vitro and in vivo data from immuno safety and toxicology studies performed with antibody drug candidates and provide expert advice to project teams
  • Collaborate with cross-functional teams to ensure the successful progression of our biologic projects from discovery through to clinical development.
  • Prepare and review regulatory documents and responses to regulatory authorities taking the lead in all Toxicology-related aspects.
  • Stay current with new developments in toxicology and immunology for Biologics human therapeutics and apply this knowledge to the design of toxicology and immune safety studies for our antibody drug candidates.

WHO YOU ARE

  • PhD in Human Toxicology, Pharmacology, or Immunology
  • DABT or ERT certification preferred
  • Minimum of 5 years of experience in the biotech/pharmaceutical industry in leading toxicology programs for antibody drug development
  • Proven track record in designing and executing in vitro an in vivo immune safety and in vivo NHP toxicology studies for antibody drug candidates
  • Practical experience as Toxicology Study Monitor capable to manage multiple CROs and vendors in parallel
  • Strong knowledge of immunology and of toxicology regulatory requirements for the development of Biologics human therapeutics
  • Excellent communication and collaboration skills
  • We expect you to come on site at least 2x/week or, if living abroad CH, 3-4x/week (due to social securities and tax reasons)

WHAT WE CURRENTLY OFFER

  • Offices: Our well-equipped laboratories and offices are located at the Tech Park, a premier address for early-stage start-ups in Basel.
  • Commuter Benefits: We support our employees tailored to their personal needs in commuting to work and offer parking facilities or a commuter contribution.
  • Flexible Working: We support flexible working as appropriate.
  • Christmas Closure: In addition to the 24 holidays per year, our offices/labs are closed between Christmas and New Year.
  • Birthday Retreat: On top of that, your birthday is your personal holiday - our employees enjoy their birthday with a day off.
  • Food: We like get-togethers during lunch time. Enjoy tasty, subsidised meals from our FELFEL food fridge.
  • Coffee: Meet up with your colleagues and grab free coffee.
  • Development: We support the individual development of our employees.
  • Creativity: We offer an innovative and creative environment.
  • People: We are an international and diverse team with talented and passionate people.
  • Fun: From time-to-time we organise cool off-site summer and winter team events.
Only applications which full fill the above requirements and Toxicology experience in Biologic drug development will be considered.

To apply, please send us this application form together with your CV, Cover Letter and Reference Letters (Arbeitszeugnisse).

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