Beschreibung
Bioanalytical Manager (f/m/d) - bioanalysis /large and small molecules / biology/biochemistry/ vendor managementProject:
For our customer a big pharmaceutical company in Basel we are looking for two highly qualified Bioanalytical Manager
Background:
The department of Bioanalytical R&D, within the unit Pharmaceutical Sciences is 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 will be on both small and large molecules. Please note we have two (potentially more) positions opened.
Perfect Candidate:
The perfect candidate is someone who has done a similar position in bioanalysis previously within a pharma (preferred) or a CRO or an experienced scientist with experience with small and/or large molecules very keen to learn and with a positive attitude. Please note the preference goes to the first profile (experience in pharma/CRO). In any case, the successful candidate will have an education within biology / biochemistry. On this position, the perfect candidate has strong experience on both small AND large molecules. However, because we have different openings we welcome candidates with experience either on small OR large molecules. Please note though that the perfect candidate will have experience on both.
This is a long-term contract with a potential internal opportunity afterwards.
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
Must haves:
* Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis
* Excellent work experience on both large and small molecules bioanalysis
- Strong vendor management experience, looking after outsourced studies to external CROs
* Degree in biology/biochemistry
Reference No.: 920313SGR
Role: Bioanalytical Manager
Industry: Pharma
Location: Basel
Workload: 100%
Start: 01.06.2021
Duration: 18 month
Deadline: 20.05.2021
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.