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Reposted 4 Days AgoSaved
In-Office
Cambridge, MA, USA
Senior level
Senior level
Healthtech • Information Technology • Biotech • Pharmaceutical
The Senior Director, CMC Program Lead will oversee CMC development and manufacturing, coordinating across multiple functions to meet program milestones.
Top Skills: BiochemistryChemical EngineeringPharmaceutical Sciences
7 Days AgoSaved
In-Office
Cambridge, MA, USA
Senior level
Senior level
Healthtech • Information Technology • Biotech • Pharmaceutical
The Director of Quality Systems and GxP Compliance ensures compliance with regulatory standards, manages the quality management system, and leads the compliance team.
Top Skills: Document Management SystemsQuality Management SystemsVeeva Vault
9 Days AgoSaved
Hybrid
Cambridge, MA, USA
Expert/Leader
Expert/Leader
Healthtech • Information Technology • Biotech • Pharmaceutical
Lead analytical development for biologics at Scholar Rock, overseeing method development, regulatory submissions, and team mentoring for monoclonal antibodies and complex biologics.
Top Skills: Binding AssaysBioinformaticsCe-SdsCiefLc-MsPeptide MappingSec
Reposted 10 Days AgoSaved
In-Office
Cambridge, MA, USA
Senior level
Senior level
Healthtech • Information Technology • Biotech • Pharmaceutical
The Vice President, CMC Technical Development will lead Scholar Rock's CMC development, overseeing drug substance, product formulation, and analytical development, while guiding global regulatory submissions and building a high-performing team.
Top Skills: Analytical DevelopmentBiologicsCell Line DevelopmentDrug ProductDrug SubstanceFormulation ScienceProcess ValidationRegulatory SubmissionsTechnology Transfer
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