Associate Principal Investigator / Principal Investigator GMP Regulations (m/f/d) (full time)

BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, Hamburg, Germany Req #112
Friday, November 12, 2021
BioAgilytix is a leading contract research organization (CRO) that specializes in large molecule bioanalysis. Our fully integrated laboratory services support every stage of biologics development, from early discovery through pre-clinical studies and clinical phases, in a fully regulated environment. The best science demands the best people, and our global team of professionals in Hamburg, Germany; Durham, North Carolina; Boston, Massachusetts; San Diego, California; and Brisbane and Melbourne Australia bring a passion for helping pharma and biotech companies achieve more for the patients they serve. Outstanding science requires great people. At BioAgilytix, you will be part of a highly professional team that supports cutting-edge bioanalytical methods with world-class biopharmaceutical services.

Essential Responsibilities:

  • Establish and maintain GMP related processes within Bioanalytical Operations on the regulatory aspects and support the scientific team on practical aspects
  • Develop and validate/supervise potency bioassays biomarker, cell-based, immunogenicity, immuno- and assays for support of preclinical, clinical and product release studies
  • Conduct/supervise routine sample analysis in GxP regulated environments
  • Fulfills the role of responsible project leader / analytical project manager for multiple projects
  • Full scientific responsibility for the assigned projects
  • Write plans/reports for method validations and sample analysis
  • Act as single point of contact for customers
  • Meet client expectations/timelines
  • Ensure deliverables are accurate and on-time
  • Present data to clients
  • Serve in a supervisor role and leading teams in a limited capacity
  • Apply knowledge of regulatory guidance to experimental planning and design
  • Responsible for budget achievement of the group
  • Familiar with the quote/contract and communicate with sales team and/ or clients accordingly
  • Communication with the sales team regarding proposal, timeline, and / or other project related issues, report to line manager when any issues are identified
  • Support the sales team with preparation and presentation of proposals in terms of science/technology
  • Present data in conferences, presentations, reports and posters
  • Participate in audits and customer visits



  • Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 8 years’ experience in a regulated laboratory environment; or
  • Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 6 years’ experience in a regulated laboratory environment; or
  • PhD in molecular biology, biochemistry, immunology, biotechnology, or related field 0-2 years’ experience in a scientific laboratory environment
  • Experience in leading a team, bioanalytical operations, and product/project management in the pharmaceutical/biotechnology industry, 2+ years’ internal Associate Principal Investigator experience, with exceptions
  • Ability to develop bioanalytical and/or immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, GyroLab, ELISPOT
  • Knowledge and experience of GxP regulations and guidelines related to bioanalytics preferred
  • Understanding and experience with assay development and GCP, GLP and/or GMP procedures is preferred
  • Experience with software PLA and/or Watson LIMS preferred
  • Must work effectively within team to meet objectives under time constraints
  • Ability to take direction well and multi-task
  • Detail oriented and highly organized
  • Excellent oral and written communication skills
  • Proficient in the use of MS Office programs
  • Demonstrated experience serving in a supervisor role and leading teams
  • Fluency in German and English is required as well as in German


Personnel responsibility for up to 4 employees

  • Analysts, Senior Analysts, Scientists

Place of work: 

  • Laboratory / Office in Hamburg, Germany
  • Occasional weekend, holiday, and evening work required
  • Occasional travel
What we offer you: Unlimited employment relationship Flexible working hours Collegial work in a highly motivated team Structured induction (onboarding, mentoring and briefing) Subsidy for the public transport network / profit ticket and company parking spaces Participation in company pension scheme and/or capital-forming benefits Additional company health insurance Team events Corporate benefits Employee referral program Good working atmosphere in an international environment Free drinks and fruit

Other details

  • Pay Type Salary
Location on Google Maps
  • BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, Hamburg, Germany