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

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

    

Skills:

• 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

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