Hybrid Project Manager – Immunology, Bioanalysis

Posted 2 hours ago

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About the role

  • Project manager overseeing bioanalytical projects in Immunology using LBA and cell-based assays. Leading responsibilities under GLP/GCP, collaborating with business development and quality assurance teams.

Responsibilities

  • Planning, execution, analysis and reporting of bioanalytical projects to support immunogenicity bioanalysis using LBA (ligand-binding) and cell-based assays as the responsible scientist
  • Serving as Principal Investigator in accordance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  • Managing the development and validation of bioanalytical methods for the quantification/qualification of large-molecule therapeutics in line with international guidelines and internal procedures
  • Providing scientific support to technical staff during sample analysis; reviewing and discussing analytical results and ensuring adherence to project capacities
  • Writing, editing and reviewing bioanalytical protocols, reports and (on request) regulatory documents
  • Discussing new project opportunities and advising clients on optimal project designs in collaboration with colleagues from Business Development
  • Reviewing service cost estimates with particular consideration of clinical study designs and translating these into appropriate bioanalytical protocols
  • Presenting results and observations from projects to clients
  • Representing bioanalytical projects during client audits and regulatory inspections in cooperation with Quality Assurance (QA)

Requirements

  • PhD / Postdoc in a scientific discipline (e.g., biotechnology, biology, biochemistry) or equivalent background
  • At least 2 years of hands-on experience in bioanalysis with a focus on immunogenicity (ADA, NAb)
  • Initial experience with GLP/GCP and relevant regulatory guidelines (FDA, EMA)
  • Scientific expertise in immunology and immunological methods
  • Excellent project management skills, analytical thinking, problem-solving abilities and strong self-organization
  • Very good German and English skills, both written and spoken
  • Very good communication skills
  • High personal commitment and a strong sense of urgency in a fast-changing environment
  • High initiative and strong team spirit

Benefits

  • Permanent employment contract
  • 30 days annual leave
  • Flexible working hours (flexitime)
  • Bike leasing
  • Company pension contribution of €72.00 per month
  • Comprehensive onboarding and tailored training and development opportunities
  • Flat hierarchies and an informal "Du" culture

Job title

Project Manager – Immunology, Bioanalysis

Job type

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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