Project Manager (m/w/d) Immunology - Large Molecules

at  Nuvisan GmbH

QUALIFICATIONS

PhD / post-doc in life sciences (e.g. food chemistry, chemistry, pharmacy, bi-ochemistry, biology) or equivalent
Experience in modern LBA methods
Expertise in relevant analytical software (e.g.MSD Discovery Workbench) for data analysis is required
Strong personal commitment and high sense of urgency in a quickly evolving environment
High personal initiative and team spirit
Distinct project management, problem-solving and analytical skills
Excellent self-organization skills
Excellent communication skills
Fluent German and English in speaking and writing is required

Plan, conduct, evaluate and report bioanalytical projects in support of PK and Biomarker bioanalysis as responsible scientist
Assume responsibilities as a Principal Investigator according to the principles of Good Laboratory Practice (GLP) or Good Clinical Practice (GCP)
Supervise the development and validation of bioanalytical methods for quan-tification/qualification of large molecule drugs according to applicable guide-lines and internal procedures via Ligand Binding Assays (LBA)
Support the technical staff during the analysis, review and discuss the analyt-ical results and be responsible to meet the timelines
Author, edit, and review bioanalytical protocols, reports and (upon request) regulatory documents
Discuss new project opportunities and consult clients in order to develop op-timal project designs in association with business development colleagues
Review service estimates in knowledge of (particularly) clinical study designs and translate those in adequate bioanalytical protocols
Communicate results and observations in projects to clients
Represent bioanalytical projects during client audits and health authority in-spections in association with Quality Assurance