Associate Director, Drug Product Commercial Manufacturing (Small Molecules) at Vertex Pharmaceuticals Inc (US) in Boston, Massachusetts

Posted in Retail 11 days ago.





Job Description:

Vertex Pharmaceuticals creates new possibilities in medicine to cure diseases and improve people's lives. The Associate Director, Drug Product Tech Transfer/Commercial Manufacturing is responsible for the successful tech transfer, validation, and commercial manufacturing of small molecule drug products in an innovative, high-science, Quality-by-Design, virtual manufacturing environment. If you are looking for a high impact technical leadership role in an industry-leading company producing important medicines, this is for you!

The Associate Director will partner with late-stage product development teams and contributes to regulatory filing activities in order to ensure the robustness of the drug product process in a commercial setting, and to maximize benefits derived from an advanced Quality-by-Design approach. The Associate Director is responsible for successful process validation and commercial manufacturing, drives resolution of complex manufacturing issues, and leads global expansion activities throughout the product lifecycle in a complex, global environment. The successful candidate will champion high-impact cross-functional initiatives and maintain strong relationships with key internal and external stakeholders. This role requires proven experience in a cGMP environment, a broad understanding of the interaction between technical, regulatory, and business challenges, and strong scientific/engineering skills in order to drive continuous improvement initiatives in a global, post-approval environment.

Key Responsibilities:

  • Ensure robustness of commercial processes for new products and line extensions through effective involvement in cross-functional late-stage development activities and regulatory filings
  • Lead drug product process validation and manufacturing activities for small molecule oral solid dosage forms and processes (batch and continuous) across a global supplier network
  • Resolve complex commercial manufacturing issues being mindful of Supply, Quality, and Regulatory constraints
  • Ensure ongoing production of timely, quality drug product by leading tech transfer, commercial manufacturing, technical support, and process monitoring/trending activities
  • Drive risk management and continuous improvement of manufacturing processes and of supporting business and quality systems
  • Provide strategic input to shape Technical Operations priorities and future growth
  • Supervise, develop, and recruit staff to support ongoing commercial manufacturing and process improvement initiatives

Minimum Qualifications :

  • PhD with 8+ years or BS/MS with 10+ years of relevant work experience
  • Advanced knowledge of cGMP's, associated CMC quality systems and regulatory considerations in a pharmaceutical setting
  • Experience in drug product manufacturing operations of oral solid and technical support
  • Demonstrated leadership, collaboration, and mentoring skills
  • Experience working with external contract manufacturing organizations (CMO)
  • Knowledge of advanced QbD concepts, and experience with their implementation for commercial products
  • Advanced knowledge of DoE and statistics
  • Expertise in continuous manufacturing, automation, PAT, and RTRT implementation

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