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Director Drug Product [29 / 09 / 2025]...

Director Drug Product [29 / 09 / 2025]...

Meet Life SciencesLima Metropolitana, Lima, PE
Hace 19 horas
Descripción del trabajo

Direct message the job poster from Meet Life Sciences

Position Title : Director / Sr Director Drug Product

Department : CMC

Location : San Diego, CA (Hybrid) in office Tuesday / Wednesday / Thursday (3days / week)

Reports To : Vice President, CMC

Position Overview

This leadership role is responsible for overseeing end-to-end development and manufacturing strategies for biologic drug products, ensuring consistent production, compliance, and clinical supply. The role requires close collaboration across technical, quality, regulatory, and supply chain functions to support process development, technology transfer, and external manufacturing partnerships.

Key Responsibilities

  • Lead drug product development and GMP manufacturing at external partners across various formats (e.g., PFS, autoinjectors).
  • Oversee technology transfers, process scale-up, validation, and clinical / commercial batch execution.
  • Manage cross-functional collaboration to ensure quality, regulatory compliance, and supply readiness.
  • Guide CDMO / CRO relationships, ensuring phase-appropriate development and execution.
  • Author technical documentation and CMC sections of regulatory submissions.

Education

Advanced degree (PhD or MS with extensive experience) in a relevant scientific or engineering discipline (e.g., Biochemistry, Chemical Engineering, Bioengineering).

Qualifications

  • 12+ years in biopharmaceutical product development, including external manufacturing oversight.
  • Proven expertise in formulation, process development, and commercialization of biologics and combination products.
  • Deep knowledge of regulatory expectations and GMP practices for late-stage drug development.
  • Experience managing CMOs / CDMOs for drug substance and drug product manufacturing.
  • Skilled communicator with the ability to influence cross-functional teams and external partners.
  • Seniority level

  • Seniority level
  • Director

    Employment type

  • Employment type
  • Full-time

    Job function

  • Job function
  • Research, Manufacturing, and Science

  • Industries
  • Staffing and Recruiting, Biotechnology Research, and Pharmaceutical Manufacturing

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    Director • Lima Metropolitana, Lima, PE

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