We are recruiting for a Bioanalytical Manager Large Molecules.
As part of the R&D, you will be responsible for characterizing and profiling new pharmaceutical compounds in pre-clinical and clinical development. The group of Regulated Bioanalysis acts as an interface for the conduct of bioanalytical development projects in cooperation with external contract research organizations (CROs), various internal pre-clinical and clinical stakeholders and health authorities.
This position will be focused on external CRO management. The successful candidate will look after studies done externally from a bioanalytical point of view (e.g measuring blood & tissue concentration in both humans & animals). This is focused on large molecules.
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. Please note the preference goes to the first profile. In any case, the successful candidate will have an education within 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 sub teams, 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 bioanalytic 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
• Start date: ASAP
• Latest start date: 3 months’ notice is acceptable
• End date: 18 months contract
• Extension: possible
• Work location: Basel
• Workload: 100%
• Onsite/Home Office: Hybrid model
• Travelling: No
• Team: 22 people
• Department: Bioanalytical R&D (PNR)
Pay rate: 70 CHF/h All in
• 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.
- analytical skill
- scientific analysis software
If you are interested, or you know anyone that might be interested, please contact me at email@example.com, or Andrea Toma at firstname.lastname@example.org
Job Title: Bioanalytical Manager Large Molecules
Location: Basel, Switzerland
Rate/Salary: 60.00 - 70.00 CHF Hourly
Job Type: Contract
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