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Principal Engineer - Permanent - Durham, NC

Lead the engineering behind next‑generation powder technologies that turn molecules into medicines.

Ñî¹óåú´«Ã½Íøygfcmw¡¤(Öйú)Õ¾Èë¿ÚÖ±½Ó½ø is seeking a Lead Engineer specializing in SD to join a dynamic team.

Primary Responsibilities:

The successful candidate will focus on designing, developing, and optimizing SD processes for late-stage oral solid dose and inhaled drug product development projects. You will work collaboratively across various scientific disciplines to ensure robust manufacturing processes and contribute to the advancement of pharmaceutical formulations.

Skills & Requirements:

• Educational background in Engineering (e.g., Chemical, Mechanical, Materials, Biomedical, or Packaging) or Pharmaceutical Sciences.
• Industrial experience in pharmaceutical SD and oral solid dose drug product development.
• Proven track record in delivering complex late-stage SD projects, including technology transfer, scale-up, and validation.
• Strong understanding of the pharmaceutical drug product development and commercialization process.
• Experience with predictive science and digital tools for process modeling.
• Knowledge of drug product control strategies and their integration into pharmaceutical sciences.
• Excellent collaborative working, communication, organizational, and planning skills.
• Stakeholder management expertise.

Preferred Skills & Knowledge

• Experience with other drug product manufacturing processes (e.g., tablet compression, coating).
• Familiarity with clinical and commercial regulatory authoring and defense.
• Experience managing relationships with external suppliers (e.g., CMOs/CROs).
• Inputting user requirements into capital projects.

The Principal Engineer's responsibilities will be:

• Lead the design and development of scalable, compliant SD manufacturing processes for new pharmaceutical formulations.
• Evaluate, select, and specify SD equipment and technologies to meet project and production needs.
• Collaborate with global teams and manufacturing partners to define critical process parameters (CPPs) influencing product quality.
• Define regulatory strategies for SD in drug products.
• Manage technical risk and ensure robust commercial manufacturing through effective risk management activities.
• Drive the adoption and advancement of in silico process modeling and control in SD.
• Oversee technology transfer, scale-up, and process validation approaches for SD.
• Provide leadership and mentorship to scientists and engineers, fostering skill development and capability building.
• Promote creativity and innovation, supporting a culture of scientific excellence.
• Stay informed on industry trends, emerging technologies, and best practices in SD to drive innovation.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Ñî¹óåú´«Ã½Íøygfcmw¡¤(Öйú)Õ¾Èë¿ÚÖ±½Ó½ø is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Ñî¹óåú´«Ã½Íøygfcmw¡¤(Öйú)Õ¾Èë¿ÚÖ±½Ó½ø is acting as an Employment Agency in relation to this vacancy.

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