Massachusetts, United StatesOperations
ProtaGene is a world-leading analytic CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and Quality system driven analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021, GeneWerk GmbH’s unique capabilities in vector safety, integration site analysis, and bioinformatics were integrated into our platforms and service offerings, establishing ProtaGene. The organization operates over four sites in Germany and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.
We are seeking a talented individual to play an important role in expanding ProtaGene’s cell and gene therapy business in the United States alongside CGT team members. In 2024, ProtaGene will continue to offer our clients an expanded cell and gene therapy portfolio, including biodistribution and integration site analysis capabilities.
Title and pay rate commensurate with experience.
- Knowledge of the GCP/GLP/GCLP regulations and principles.
- Generate project/trial plan according to SOPs and guidance documents according to the scope of participation in the clinical trial / preclinical study.
- Help execute and support GCP/GLP/GCLP compliant or research projects.
- Participate in the establishment, transfer, standardization, and optimization of assays.
- Report and document unexpected assay occurrences, deviations, and out-of-specification results in compliance with existing regulations.
- Support the lead Scientist and Project Manager in customer relationships.
- Support the lead Scientist in the analysis of Molecular Bioanalytic assay project data.
- Assist in the generation and update of laboratory SOPs.
- BS degree in life sciences or related field with some biopharmaceutical experience.
- 2-3 years’ experience in a similar role or field.
- Experience working in GCP/GLP/GCLP compliant settings, including the generation of controlled documents and project documentation.
- Experience with analytical method planning and analysis.
- CRO experience a plus but not required.
- Highly motivated team member with high degree of initiative and ability to work independently within a global work environment.
- Excellent interpersonal and communication skills.
- Enthusiasm for scientific excellence with motivation for making contributions in a team environment.