Senior Scientist, Bioanalysis

3 weeks ago

Waltham, Massachusetts, United States Dyne Therapeutics Full time
Company Overview:

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).

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 successful candidate is expected to have hands-on experience in ligand binding assay development for PK and immunogenicity assessments in preclinical and clinical studies.

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

Primary Responsibilities Include:

Design, develop and/or optimize sensitive quantitative GLP-like ligand-binding assays (LBAs) according to bioanalytical guidance to industry to measure Dyne proprietary drugs in
Collaborate cross-functionally with Platform, Research and Non-Clinical teams.
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 in the field of GLP-like quantitative LBAs.
Hands-on assay development experience with different ligand binging assay formats and detection methods required (knowledge of LC/MS assay development is not a requirement for this position).
Broad, and in-depth knowledge of FDA bioanalytical guidance to industry.
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.

#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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