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Senior Process Engineer (Pharma) – Top Dollar
RTP, NC 27709 United States
Research and Development
Seek smart, skilled, and knowledgeable Process Engineer to assume key role with an RTP area pharmaceutical company. This company is developing a portfolio of innovative therapies based on its cutting edge, proprietary technology. Seek exceptional candidate who will drive the process engineering effort, within its GMP-compliant facility. Company will pay excellent wage to attract and retain a star.
This Company boasts a growing portfolio of products that are highly anticipated by both the medical and business communities, and it is imperative that the right people and processes are in place to prepare for commercialization. This Engineer will be critical to that effort.
Key things to note:
• This is a young company with multiple launches planned. Scale-up, tech transfer and process optimization experience will be important.
• The company has developed a platform that will serve as the foundation for numerous innovative therapies. Experience building out a portfolio of products would be valuable.
• This is an emerging company in which policies, practices and procedures are still being developed. This Engineer will be instrumental in creating the blueprint that others will follow.
• This is a collaborative role that will involve partnering with Manufacturing, R&D and QA as well as vendors and independent consultants on scale-up, process optimization, tech transfer, etc. We seek an engaging collaborator.
• These are semi-solid drug products.
The focus of the role will be to drive all automation and technology development activities within the company to ensure optimal results. Specific duties will include:
• Work with R&D and QA in new product scale-up, process optimization, tech transfer and process validation activities
• Design, build, acquire and maintain methods and tools for process improvements
• Perform development and implementation of new process technology
• Perform process design and process simulation studies to support process automation projects
• Work with the R&D team to design and scale-out processes and support process validation
• Create, edit and execute protocols and writes protocol reports
• Interact with technical staff in the tech-transfer of manufacturing processes
• Act as Subject Matter Expert regarding manufacturing. Lead continuous improvement efforts
• Establish operating equipment specifications and improve manufacturing techniques
• Design, document and perform IQ/OQ/PQ and test method qualifications for equipment and processes
• Install and maintain technology equipment such as compressors, pumps, gas panels, reaction vessels, and other equipment used in process chemistry. Troubleshoot equipment malfunctions
• Author technical reports and assist in the preparation of CMC sections for global regulatory filings.
Targeted candidate will offer a related Scientific or Engineering degree and 5+ years of experience in pharmaceutical process development including all/most functions noted above. Proficiency working with chemical plant, vacuum, electromechanical, high pressure, and high purity gas systems will be important.
Other priorities include:
• Hands-on work style – including readiness to handle mechanical assembly and routine experimentation
• Experience bringing product from R&D into commercialization (tech transfer; scale up)
• Superior project management skills
• Strong commitment to continuous improvement
• Longevity and impact in previous positions
Finally and critically, we seek a focused, take-charge, mission-driven achiever. A lot is happening and growth potential is enormous. We seek a highly skilled and capable contributor who will thrive.
This is an immediate need. Please forward Word resume for prompt consideration.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
North Carolina Biotechnology Center