Principal Engineer, Continuous Direct Compression - Permanent - Durham, NC
Ready to lead projects that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!
探花合集 is seeking a Principal Engineer with expertise in Continuous Direct Compression (CDC) focusing on driving late鈥憇tage oral solid dose drug product development.
Primary Responsibilities:
In this role, you will lead CDC process and equipment oversight, playing a key part in advancing oral small鈥憁olecule drug products. Success will rely on close collaboration across multidisciplinary scientific teams and the effective use of predictive tools and digital鈥憈win technologies.
Skills & Requirements:
- Academic background in Engineering (e.g., Chemical, Mechanical, Materials, Biomedical) or Pharmaceutical Sciences.
- Hands鈥憃n industry experience in CDC or pharmaceutical spray鈥慸rying technologies.
- Strong knowledge of oral solid dose (OSD) development and commercialization pathways.
- Demonstrated success in delivering complex, late鈥憇tage oral drug product programs, including tech transfer and validation.
- Experience using predictive modeling tools and digital simulation approaches.
- Understanding of integrated drug鈥憄roduct control strategies across pharmaceutical science disciplines.
- Effective collaboration and communication skills for working with cross鈥慺unctional teams.
- Strong organizational and planning abilities to consistently meet quality and timing targets.
- Proven capability in stakeholder management.
- Background in scaling up and transferring other drug鈥憄roduct manufacturing processes (e.g., granulation, tableting, coating).
- Familiarity with authoring and defending regulatory submissions for clinical and commercial stages.
- Experience managing partnerships with external suppliers, including CMOs and CROs.
- Knowledge of automation technologies and process鈥憁odeling platforms.
The Principal Engineer's responsibilities will be:
- Lead engineering initiatives within CDC to design and refine robust manufacturing processes for pharmaceutical formulations.
- Drive technical risk鈥憁anagement strategies to ensure strong, reliable commercial manufacturing performance.
- Partner with global teams and external collaborators to define critical process parameters (CPPs) that impact product quality.
- Enhance CDC's in鈥痵ilico modeling and process鈥慶ontrol capabilities.
- Guide technology transfer activities and shape process鈥憊alidation strategies for CDC.
- Help shape network capability needs for CDC by working closely across technical and supply chain functions.
- Collaborate with equipment suppliers to assess, recommend, and implement technology upgrades.
- Provide direction, mentorship, and development support to scientists and engineers to build team capability.
- Champion innovation and creative thinking to nurture a culture of scientific excellence.
- Keep current with industry developments, new technologies, and best practices in continuous processing.
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.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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