Senior Scientific Project Manager - Molecular

LabConnect•Johnson City, TN

About The Position

The Senior Scientific Project Manager – Molecular will be responsible for providing project management oversight to a biopharmaceutical client tasked with managing and executing analytical testing, method development and/or validation of such assays as immunoassays, bioassays, pharmacokinetic and/or flow cytometry assays under Good Laboratory Practices (GLP). He/she will provide project management and technical support to teams conducting training, technical transfer, data review and trending analysis. The Senior Scientific Project Manager – Molecular must have the ability to effectively monitor the performance of CROs and service providers. The incumbent will also be responsible for operational documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports. Essential Duties and 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, bDNA, and hELISA
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

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.