Description
Bioanalytical Manager in Large Molecule (m/w/d)- bioanalysis/pharma/ SAP/English /GermanProject:
For our customer a big pharmaceutical company in Basel we are looking for a Bioanalytical Manager in Large Molecule.
Background:
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 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.
Perfect Candidate:
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. 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 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 (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 - Excellent written and oral communication in German and English
- Work experience in GMP environment, supply chain, life science, industrial engineering or equivalent is beneficial.
- Ability to work independently. Self-motivated, proactive, quick thinking, adaptable and well-organized individual. Ability to set priorities and to remain flexible in stressful situations
- Excellent team player with a high level of communication and negotiation skills
- Customer-focused, ability to create trustful relationships with business partners
- Demonstrated problem solving and decision making skills
- Project management skills and experience in lean tools application is beneficial
- Knowledge of SAP R3, APO knowledge is beneficial
Reference No.: 919645SGR
Role: Bioanalytical Manager in Large Molecule
Industry: Pharma
Location: Basel
Workload: 100%
Start: ASAP
Duration: 18++
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: .