Pharmacokinetics and Drug Metabolism Specialist 1

hace 2 semanas

SFEL RD SANT FELIU DE LLOBR, España Almirall A tiempo completo
Mission
  • Be a member of R&D teams to provide an expert DMPK & Bioanalysis support to Large Molecule therapy projects.
  • Implementation and validation of adequate bioanalytical strategies, with focus on PK assays, PD assays and immunogenicity assays, across the project lifecycle in a multidisciplinary environment.
  • Coordinate sample analysis including non-regulated or regulated pre-clinical and clinical studies.
  • Supervision and monitoring of external bioanalytical and ADME/DMPK studies.
Tasks and Responsibilities
  • Participation, performance, direction or outsourcing of studies to improve the knowledge of ADME/DMPK of drugs under development.
  • Implement, develop, optimize, validate, or outsource Ligand Binding Assays for PK, PD or Immunogenicity testing.
  • Take responsibility of all bioanalytical needs in house or from external vendors to support non-clinical and clinical studies.
  •  Responsible for the analysis, interpretation and reporting of data generated both internally and from external vendors.
  • Ensure that PK, PK/PD, dose predictions or other related non-clinical or clinical PK deliverables are undertaken to best practice standard for study design and regulatory submissions.
  • Ensure the correct fulfillment of GLPs for regulated bioanalytical activities and the alignment with international regulations when necessary.
  • Preparation and approval of SOPs (Standard Operating Procedures) in the field of Bioanalysis and Pharmacokinetics/Metabolism.
  • Collaborate with and support Non-Clinical, Clinical, Regulatory, Project Management or other R&D disciplines.
  • Author high quality reports, including support to regulatory documents including INDs, CTAs and NDA filings when needed.
Education
  • PhD in Pharmacy, Chemistry, Biochemistry or Biology
Specific Knowledge

 

  • Good knowledge of regulatory bioanalysis and excellent expertise/hands-on in the development/validation of Ligand Binding Assays for PK, PD or Immunogenicity testing.  
  • Experience in Biomarker assays using LBA or other bioanalytical platforms will be valued.
  • Specific bioanalytical knowledge applied to both small and large molecules (LC-MS/MS) is a plus.
  • Experience in the use of pharmacokinetic analysis software, such us Phoenix, and good understanding of the PK and PK/PD principles to interpret results. 

 

Experience
  • 5+ years of experience in the field of ADME/DMPK/Bioanalysis of Large Molecule Drugs.
Competencies
  • Teamwork and personal leadership.
  • Ability to work in a matrix environment, multi-task, meet deadlines and deal with evolving priorities.
  • Excellent communication and written skills in English
Values
  • Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
  • Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
  • Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets. 
  • Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.

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