Senior Scientific Project Manager - Molecular

LabConnect is a global company focused on delivering Central Laboratory Services to pharmaceutical and biotech companies, as well as clinical research organizations. The Senior Scientific Project Manager – Molecular will oversee project management for analytical testing and method development, ensuring compliance with Good Laboratory Practices while coordinating with teams and managing documentation.

Responsibilities:

• Lead the design and optimization of bioanalytical assays, addressing critical challenges in tissue handling/processing, sensitivity and specificity, and multiplex assessment of multiple endpoints in a single sample
• Spearhead the strategic planning and execution of ex vivo bioanalytical projects, including the selection of appropriate CROs and assay platforms with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement
• In collaboration with CROs, develop and optimize mRNA, protein, and oligo exposure assays specifically for tissues treated ex vivo with oligonucleotides or gene therapies, with emphasis on nervous system-related tissues
• Coordinate with internal stakeholders including chemistry, biology, and ADME teams
• Develop and validate Protein Biomarker assays for DRG, nerve, and skin tissues
• Leverage expertise in platforms with high levels of sensitivity, including single cell and spatial RNAscope endpoints, to provide a deep, nuanced understanding of RNAi delivery
• Retrospectively evaluate and compare datasets across past experiments to generate understanding of assays performance
• Work with large data sets, using database and/or coding approaches, to organize, interpret, and share results
• Move oligonucleotide projects from preclinical to first-in-human studies, leveraging experience in the use of rodent NHP intrathecal models to rapidly actively advance projects into the clinic
• Interact with U.S. and international CROs and effectively communicate updates, reports and recommendations to management teams
• Provide analytical project oversight by performing data review and trending analysis, evaluate assay quality, monitor performance and manage timelines
• Recommend and implement new processes and procedures to standardize, simplify and enhance quality and compliance of the department’s operations
• Participate in the management and control of GLP documentation and records, and contribute to and (co)author scientific and/or operational documents such as SOPs, validation protocols and reports, transfer protocols and reports, posters, journal publications and other technical reports

Requirements:

• PhD in Molecular Biology, Biochemistry, Genetics, or a related field is required, and a focus on RNA biology, RNA therapeutics, and ex vivo tissue analysis is strongly preferred
• Minimum of 5 years of experience in bioanalytical assay development for RNA based therapeutics in a pharmaceutical or biotechnology setting
• Alternatively, MS or BS/BA in indicated fields with a minimum of 10 years of experience will be considered
• Proven experience in overseeing collaborations with external Contract Research Organizations (CROs) and internal ADME teams
• Deep experience in bioanalysis of tissues from rodent and NHP models
• A thorough understanding of bioanalytical methods with a focus on designing, optimizing, validating, and overseeing molecular, biochemical, or cell-based assays to advance research and drug discovery
• Hands-on expertise in nucleic acid quantification methods including LC-MS, RT-qPCR, SL-qPCR, RNAseq, DNA, and ELISA
• Demonstrated skill in selection, development, and troubleshooting of molecular assays such as ELISA, capillary electrophoresis, bead-based multiplex platforms (e.g. Luminex), Simoa, and MSD
• Proficiency in data handling, analysis, and presentation for large in vivo datasets, using database and/or coding tools (e.g. Spotfire, python)
• Entrepreneurial mindset, eager to quickly and efficiently develop and apply endpoints within fast-moving projects
• Adept at adapting strategies based on evolving data, technologies, and portfolio requirements
• Exceptional communication skills, both written and verbal, with the ability to articulate complex scientific concepts to a variety of audiences and demonstrate proficiency in scientific documentation and reporting
• Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA)
• Strategic project oversight in regulated scientific environments
• Strong cross-functional leadership and stakeholder coordination
• Advanced problem-solving and analytical thinking
• Ability to manage vendor relationships and performance
• Adaptability in fast-paced, remote work settings