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Insmed

Develops therapies for rare diseases

Director Process Chemistry

Bioprocess & BiomanufacturingUpdated on Nov 13
Full-timeRemote in USA

About the Job

Requirements

  • A PhD and at least 5 years of experience managing development and execution of active pharmaceutical ingredient manufacturing processes.
  • At least 5 years of experience leading teams implementing pharmaceutical manufacturing technology improvements in a regulated environment.
  • Experience managing contract manufacturing organization operations.
  • Experience with new chemical entities, including total synthesis and physical organic chemistry.
  • Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals.
  • Experience technically authoring chemistry, manufacturing, and controls drug substance sections of regulatory filings and dossiers.
  • Awareness of Regulatory, Quality Assurance, and current Good Manufacturing Practice requirements.
  • Strong interpersonal skills and the ability to work in a fast-paced, multidisciplinary environment.
  • Strong verbal and written communication skills.

Responsibilities

  • Manage active pharmaceutical ingredient, intermediate, and regulatory starting material 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 chemistry, manufacturing, and controls 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 chemistry, manufacturing, and controls development through a discovery process chemistry philosophy.
  • Oversee technology transfer, scale-up, process optimization, and clinical and commercial manufacturing, ensuring continued refinement and enhancement of the manufacturing process.
  • Provide technical support as the internal subject matter expert and conduct technical review of quality documentation.
  • Manage schedules, raw material consumption, budgets, and process-improvement projects.

Desired Qualifications

  • A PhD in Organic Chemistry with organic synthesis expertise, or a PhD in Chemical Engineering with crystallization or solid-state expertise.
  • At least 10 years of experience managing development and execution of active pharmaceutical ingredient manufacturing processes for products marketed in the United States, European Union, and Japan across the full development-to-launch lifecycle.

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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