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Insmed

Develops therapies for rare diseases

Associate Director - Process Chemistry

Bioprocess & BiomanufacturingUpdated on Nov 13
Full-timeRemote in USA

About the Job

Requirements

  • A PhD and at least 2 years of experience managing development and execution of active pharmaceutical ingredient (API) manufacturing processes, or a Master's and at least 6 years of that experience.
  • At least 5 years of experience leading teams implementing pharmaceutical manufacturing technology improvements in a regulated environment.
  • Experience managing contract manufacturing organization (CMO) operations.
  • Experience in new chemical entities (NCE), including total synthesis and physical organic chemistry.
  • Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals.
  • Experience providing technical authoring of chemistry, manufacturing, and controls (CMC) drug substance sections of regulatory filings and dossiers.
  • Awareness of regulatory, quality assurance, and current Good Manufacturing Practice (cGMP) requirements.

Responsibilities

  • Manage API, intermediate, and registered starting material (RSM) manufacturing at contract manufacturing organizations, including synthesis route and early-stage process identification, technology transfer, process optimization, clinical and commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy.
  • Act as the Technical Operations collaborator with the research team for lead optimization and early development programs.
  • Drive cross-functional interaction between lead optimization research and early CMC development through a discovery process chemistry (DPC) philosophy.
  • Oversee technology transfer, scale-up, process optimization, and clinical and commercial manufacturing, and ensure continued refinement and enhancement of manufacturing processes.
  • Provide technical support as the internal subject matter expert, review quality documentation, manage schedules, raw material consumption and budgets, and manage process-improvement projects.

Desired Qualifications

  • A PhD in Organic Chemistry (synthesis) or Chemical Engineering (crystallization).
  • At least 10 years of experience managing development and execution of API manufacturing processes for products marketed in the United States, the European Union, and Japan.

About the Company

Insmed

Develops therapies for rare diseases

Insmed focuses on developing and delivering therapies for serious and rare diseases. Its products come from a pipeline of clinical trials and approved treatments, sold to patients in global markets with offices in Bridgewater, NJ, Europe, and Japan. The company’s work combines research and development, regulatory approvals, and commercialization to bring therapies from discovery to patients. Insmed differentiates itself by addressing unmet medical needs in rare diseases and maintaining a global infrastructure that supports development, approval, and patient access. The goal is to improve patient outcomes by providing effective treatments for conditions with limited existing options.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Bridgewater Township, New Jersey
Founded
1988

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