Senior Scientist, Bioanalysis

Role Summary:

This role plays a critical role in advancing our pipeline of novel treatments through the application of cutting-edge bioanalytical techniques. This includes designing, developing, optimizing, and validating bioanalytical in complex biological matrices with a focus on muscle tissue and fluids. The person in this role is expected to utilize state-of-the-art LC-MS/MS instrumentation for the quantitative analysis of biomarkers, metabolites, and therapeutic compounds in preclinical and clinical samples.

This role is based in Waltham, MA without the possibility of being a remote role. Candidates must be able to relocate.

Primary Responsibilities Include:

• Provide bioanalytical support for portfolio, including complex method development and troubleshooting for PK and immunogenicity assays across several programs.
• Collaborate cross-functionally with Platform, Research and Non-Clinical teams.
• Design, develop and/or optimize sensitive quantitative assays to measure Dyne proprietary drugs in different matrices (plasma, urine, tissues) and from different species (rodents, non-human primates, human).
• Setup and maintain lab instrumentation.
• Evaluate assay performance, ability to troubleshoot issues.
• Perform data analysis and interpretation.
• Track progress against project timelines, generate regular status updates, and communicate progress and issues to management.
• Maintain a well-documented laboratory notebook.
• Effectively manage workload with minimal supervision.
• Adhere to safe laboratory practices.
• Multi-task across several projects and manage time effectively to achieve results.
• Collaborate to identify external vendors (CRO) for new outsourced projects and request contracts.
• Transfer bioanalytical assays to CROs, oversee assay validation and sample testing. 

Education and Skills Requirements:

• BS or MS in Pharmaceutical sciences with at least 6-8 years of experience in the pharmaceutical industry or PhD degree with at least 4 years of industry experience
• Broad, and in-depth knowledge of FDA bioanalytical guidance to industry
• Hands-on assay development experience with different ligand binging assay formats and detection methods required
• Strong assay troubleshooting, data analysis and interpretation skills
• Excellent verbal and written communication skills
• Ability to work collaboratively in a team-oriented environment
• Strong attention to detail, organizational skills, and ability to multitask
• Demonstrated ability to troubleshoot and solve problems

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