Bioanalytical Manager Small Molecules (f/m/d)
Posted on Aug 31, 2021 by ITech Consult
Bioanalytical Manager Small Molecules (f/m/d) - bioanalysis/small molecules/ pharma industry/biochemistry/ CRO
For our customer a big pharmaceutical company in Basel we are looking for two highly qualified Bioanalytical Manager
As part of the Pharma Research and Early Development organisation in Basel, the department of Bioanalytical R&D, within the unit Pharmaceutical Sciences is responsible for characterising 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 internal pre-clinical and clinical stakeholders, external contract research organizations (CROs) and health authorities.
The successful candidate will interact with external CROs and internal project teams for conducting small molecules bioanalytical work according to regulatory guidance. He/she will manage full bioanalytical support for the assigned multiple projects by providing support to internal project teams and directing bioanalytical work at CROs.
The perfect candidate is someone who had a similar position in bioanalysis previously within a pharma (preferred) or a CRO or an experienced scientist with experience with small molecule bioanalysis very keen to learn and with a positive attitude. Please note the preference goes to the first profile (experience in pharma/CRO). The successful candidate will have an education within chemistry/biology/biochemistry. This is a contract with potential internal opportunity afterwards.
Please note onsite work will be required. The specifics (days onsite vs home office) will be discussed with the manager. Please note remote work is not an option and we expect candidates to be able to be onsite.
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 development compounds (drugs) and any concomitant/interaction compound in the given project.
. Manage and direct analysis of samples and timelines from preclinical and clinical studies for the project at CRO labs.
. Participate actively in expert teams; act as primary contact person for DMPK and clinical project leaders.
. Interact proactively with the assay development team.
. Ensure full compliance with the current global and local bioanalytical guidance and GxP.
. Leadership in Bioanalysis.remain current and continually develop expertise in bioanalytical sciences. 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 the 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.
* 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 small molecule bioanalysis
. Strong vendor management experience, looking after outsourced studies to external CROs
. Degree in chemistry/biology/biochemistry
- experience in Regulated Bioanalysis (eg experience in pharma industry is highly advantageous).
-experience with Small Molecules is needed.
Reference No.: 920599SGR
Role: Bioanalytical Manager Small Molecules
Industry: Pharma Location: Basel
Duration: 18 months
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.
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.