105 days ago on roche.com

Bioanalytical Manager, Large Molecule Bioanalysis

Roche AG

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Bioanalytical Manager, Large Molecule Bioanalysis

Bioanalytical Manager, Large Molecule Bioanalysis

Switzerland, Basel-Town, Basel

In a regulated bioanalysis environment, act as Bioanalytical Expert to deliver high quality and timely bioanalytical strategies, data and reports to non-clinical and clinical project teams.  Interact with external CROs and internal project teams for conducting bioanalytical work according to regulatory guidances. They will Manage full bioanalytical support for assigned multiple large molecule projects (biologics, LNAs, peptides and ADCs) by providing support to internal project teams and directing bioanalytical work at CROs. This role will report to the Head of Large Molecule Regulated Bioanalysis.
  • Ensure the transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies, soluble targets and any concomitant/ interaction compound in the given project, from internal assay development labs to external CROs
  • Manage and direct analysis of samples and timelines from non-clinical and clinical studies for the project at CRO labs
  • Participate actively in DMPK, clinical and study management sub-teams
  • Review protocols and guide project teams in all aspects of bioanalytical work required for the project, including the interpretation of immunogenicity data
  • Ensure full compliance with the current global and local bioanalytical regulatory guidances and GxP’s
  • Leadership in Bioanalysis: Remain current and continually develop expertise in bioanalytical science of large molecules, including immunogenicity testing. Guide and manage the bioanalysis of large molecules at CROsand ensure that most advanced and most efficient procedures are used
  • Review and write reports for regulatory submissions; support filings and answer any questions coming from the regulatory agencies
  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
    A PhD degree or equivalent with strong background in analytical chemistry of large molecules and at least 5 years of experience in a Bioanalytical or DMPK department of a Pharma company is preferred.
    • Demonstrated experience in the area of bioanalytics of large molecule drugs (ELISA) including immunogenicity testing and CRO monitoring
    • Excellent communication skills and ability to work in a matrix organization
    • Sound knowledge of the regulatory environment specific to bioanalytical work
    • Recent and relevant work in a Pharma company lab or outsourcing function where regulated bioanalysis is run according to the FDA and EMA guidelines
    • Strong people skills; ability to represent function and provide leadership in a multidisciplinary project team
    • Commitment to maintain high quality of delivered data, compliance and scientific quality, optimal use of resources
    • Self-motivation, ability to work independently in a matrix organization, goal setting, sense of responsibility, team player, attention to details, interest in continuing improvements, ability to focus and prioritize, excellent communication skills
    • Very good knowledge of English (spoken and written)
  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Research
    • Subfunction Toxicology / Preclinical Safety / Pathol
    • Schedule Full-time
    • Job level Individual Contributor
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Date 2016/10/11
    • Job-ID 3243962955
  • Get in touch
    D. Ferreira +41 61 688 21 90