Bioanalytical Manager in Large Molecule (Pharma)
Posted on Sep 1, 2020 by NextLink Solutions
Are you looking for an interesting and challenging opportunity in Switzerland.
Next Link is looking for Bioanalytical Manager in Large Molecule to work in Basel, Switzerland for an 18 month contract (possible extension) for a multinational client.
Next Link Solution, a Swiss IT Consultancy Company that has been providing both IT services and IT staffing to major customers for the past 20 years, has an excellent opportunity that can take your career to the next level.
Job title: Bioanalytical Manager in Large Molecule
Location: Basel, Switzerland
Duration: 18 months contract (possible extension)
Remote/Home Office: up to a day normally (team still working from home now)
Deadline to respond: ASAP
The perfect candidate is someone who has done a similar position previously within a pharma (preferred) or a CRO, focusing on large molecules. The manager is also open to an experienced scientist with strong focus on large molecules very keen to learn and with a positive attitude.
Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis (first option preferred)
Excellent work experience of large molecules bioanalysis
Strong vendor management experience, looking after outsourced studies to external CROs.
Degree in biology/biochemistry
Tasks & Responsibilities:
Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needs
Responsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.
Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant/interaction compound in the given project.
Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.
Participate actively in PS subteams, act as primary contact person for DMPK project leader.
Act as Bioanalytical Leader when required. Interact proactively with the assay development team.
Ensure full compliance with the current global and local bioanalytical guidance and GxPs.
Leadership in Bioanalysis.remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required;.maintain current expertise in the validation and conduct of bioanalytical assays;.guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.
Provide technical leadership in issue resolution.
Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.
Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.
Maintain open links with other disciplines within the department and the organization.
Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issues