Dyne Therapeutics
Senior Scientist, Process Development - Bioconjugation
Waltham, MA · Senior
Sponsorship not specified$147k-$180kDetected 21 days ago
Project ManagementNegotiationSupply ChainGMPFDA RegulatoryResearchMass SpectrometryProtein AnalysisAnimal StudiesCommunicationRegulatory Affairs
About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Requirements
- Experience in biopharmaceutical CMC management and/or Research & Development preferably in a clinical-stage biotechnology company.
- Familiarity working with oligonucleotides including but not limited to morpholino oligonucleotides, antisense oligonucleotides, and siRNA is desired.
- Hands on experience with analytical techniques for characterization of conjugates including HPLC/UPLC, SEC, SDS-PAGE, ion exchange chromatography, and UV/vis.
- Experience with oversight of external contract development and manufacturing (CDMO)
- Ability to problem solve emerging issues related to drug substance development.
- A strong understanding of biologics and small molecule manufacturing, analytical development, quality control, quality assurance, and regulatory functions.
Skills
- Represent bioconjugation Drug Substance process as a technical leader in internal cross-functional CMC teams.
- Prepare technical source documents, publications, and oral presentations.
- Prepare and review relevant CMC and product related sections and documentation for global regulatory submission.
Compensation
- $147,000 - $180,000 USD
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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