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!
Proclinical is seeking a Principal Engineer with expertise in Continuous Direct Compression (CDC) focusing on driving late‑stage 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‑molecule drug products. Success will rely on close collaboration across multidisciplinary scientific teams and the effective use of predictive tools and digital‑twin technologies.
Skills & Requirements:
- Academic background in Engineering (e.g., Chemical, Mechanical, Materials, Biomedical) or Pharmaceutical Sciences.
- Hands‑on industry experience in CDC or pharmaceutical spray‑drying technologies.
- Strong knowledge of oral solid dose (OSD) development and commercialization pathways.
- Demonstrated success in delivering complex, late‑stage oral drug product programs, including tech transfer and validation.
- Experience using predictive modeling tools and digital simulation approaches.
- Understanding of integrated drug‑product control strategies across pharmaceutical science disciplines.
- Effective collaboration and communication skills for working with cross‑functional 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‑product 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‑modeling 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‑management 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 silico modeling and process‑control capabilities.
- Guide technology transfer activities and shape process‑validation 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.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy
.png)
.png)
