Bioanalytical Manager in Large Molecule (m/f/d)

REFERENCE NUMBER:

491036/1

MY DUTIES:

- 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

MY QUALIFICATIONS:

- Profound experience in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis (first option preferred), focusing on large molecules
- Excellent work experience of large molecules bioanalysis
- Strong vendor management experience, looking after outsourced studies to external CROs
- Degree in biology/biochemistry

MY BENEFITS:

- You will work in an international environment
- This is a long term contract with a potential internal opportunity afterwards

PROJECT INFORMATION:

- One of the biggest pharmaceutical company of the world 

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Natascha Hanser

Reference number
491036/1

Contact
E-Mail: [email protected]