Location: Durham, North Carolina, USA
Full Time
Summary:
Our client, a leading pharmaceutical company in the R&D sector, is seeking a highly skilled Principal Process Development Engineer to join their team in Durham, North Carolina. As a Principal Process Development Engineer, you will be responsible for developing and optimizing processes for the production of pharmaceutical products, with a focus on ophthalmology, from early stage through clinical development.
Key Responsibilities:
- Develop and optimize processes for the production of pharmaceutical products
- Work closely with cross-functional teams to ensure successful transfer of processes from R&D to manufacturing
- Conduct process characterization studies to ensure robustness and scalability of processes
- Develop and implement process control strategies to ensure consistent product quality
- Identify and implement process improvements to increase efficiency and reduce costs
- Provide technical support to manufacturing and other internal teams (formulation, analytical, regulatory, etc.) as needed
Mandatory Skills:
- Bachelor's or advanced degree (MS or PhD) in Chemical Engineering or related field
- Experience in small molecule, drug process development
- Strong knowledge of GMP Compliance requirements
- Strong communication and interpersonal skills
Desirable Skills:
- Experience with Tech Transfer of Drug Product, Medical Device or Combination Product Manufacturing Processes
- Experience with Solid Dosage Forms, Hot Melt Extrusion, Modified Release Dosage Forms, and/or Sterile Products
The expected compensation for this position will be from $125,000-$140,000 with a 15% annual bonus.
