Senior Scientist Bioanalysis - 12 months (T2305)
Debiopharm, Switzerland

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique development only business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

Here: https://apply.workable.com/debiopharm-group-sa/

For our Translational Medicine organization based at our Headquarters in Lausanne, we are looking for a

Senior Scientist, Bioanalysis (temporary 12 months)

In this role, you will contribute to the development of the bioanalytical scientific strategy and manages assigned bioanalytical activities to add value to, support, and accelerate the development of Debiopharm’s innovative therapeutics, mainly in Oncology, in accordance with development plans, regulatory requirements and internal procedures and policies.

Your responsibilities will be but not limited to:

• Leads the bioanalytical activities defined in the Translational Medicine Development
• Plan for assigned projects
• Manages finance, budget and timelines related to assigned bioanalytical activities
• Designs, plans, manages and reports the bioanalytical studies of DPI compounds in development (either small molecules or biologics) and, as applicable, related moieties (metabolites or biological moieties); anti-drug antibodies (for immunogenicity evaluation); other drugs (SOC, comedication, probes); or biomarkers
  • Method development
  • Method qualification and validation
  • Method transfer and cross-validation
  • Study sample analysis (bioanalytical phase) of non clinical pharmacokinetic (PK), toxicokinetic and other ADME studies, either exploratory or regulatory studies;
• may support PK data and results interpretation in these studies
• Manages the bioanalytical phase of assigned clinical studies
  • Participates in the preparation of IB, informed consent forms, lab manual and clinical protocol, SAP and CSR, and other study-related documents
  • Determines/develop the methodology, implement and manage the PK samples analysis and reporting according to GCPs and GCLPs
  • Implement appropriate data transfer to Data Management
  • Ensures adequate filing of bioanalytical study documents in the e-TMF
  • Member (as Bioanalyst) of the Clinical Study team
  • May support clinical PK data interpretation and represent the Clinical
• Pharmacology function in Clinical Study teams
• Manages outsourcing activities to an international network of CROs or through academic collaborations or consultants
  • Preparation of requests for proposal
  • Leads vendor selection
  • Audits technically the vendor sites and processes, collaborate with external auditors, review audit report and contribute to CAPA plan
  • Participates in contracts review and budget negotiation
• Identifies the intellectual property, inventions and innovation opportunities, and collaborates with legal department to feed DPI’s patent portfolio
• Supports to Regulatory Affairs, Market Intelligence amp; Market Access activities
  • Contributes to the preparation of the bioanalytical documentation (IB, summaries for IND and IMPD, briefing documentation)
  • May participate in interactions with health authorities and health technology assessment (HTA) bodies
• Participates in external scientific communications (publications, poster and oral presentations, and press releases)
• Contributes to in/out licensing activities
  • Participation in the evaluation of new external opportunities
  • Participation in due diligences
  • Participation in out-licensing activitie

Requirements

• PhD in Sciences and at least 5 years professional/industry experience in bioanalysis with one strong expertise for one technology and good knowledge for others, at least in LC-MS/MS and in immunoanalytical
• Knowledge and understanding of GCP, GCLP, GLP and ICH guidelines for bioanalysis across phases of developm

Job Rewards and Benefits