Molecular Bioanalytical Research Associate (Temp-to-Perm)

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’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 Europe 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. The candidate is expected to work closely with scientific team members within. The position will report to the Laboratory Manager for Cell & Gene Therapy, Research & Development in Burlington, MA.

Responsibilities:

• Successfully execute key Molecular Biology tasks, including nucleic acid isolation, qPCR and digital PCR on, as well as customized library preparation for DNA/RNA sequencing and library sequencing, preclinical and clinical samples for research grade and G(C)LP compliant projects.
• Participate in the establishment, transfer, standardization, and optimization of assays, as well as in the execution of method qualifications/validations.
• Report and document unexpected assay occurrences, deviations, and out-of-specification results in compliance with existing regulations.
• Document experiments, results and findings in laboratory notebook and LIMS system according to Good Documentation Practices and established QM procedures.
• Assist in the generation and update of laboratory SOPs.
• Collaborate in the setup, preventive maintenance and verification of lab equipment, and the preparation of device-related documentation (IQ/OQ, PQ and CSV documentation).
• Contribute to laboratory maintenance tasks, including ordering and maintaining stock and resources.

• BS degree in life sciences or related field with some biopharmaceutical or related CRO experience is preferred, but not critical.
• Background in sample processing and/or molecular assay development within G(C)LP compliant environments is preferred, but not critical.
• Experience with analytical method qualification, transfer, validation, and general understanding of regulatory requirements (GxP) for biotherapeutics development is a plus.
• 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.