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Job: Process Development Engineer (Semi-Solid Drug Products) – Top Dollar, Frankel Staffing Partners, RTP, NC
Process Development Engineer (Semi-Solid Drug Products) – Top Dollar
RTP, NC 27709 United States
Research and Development
Our client, an RTP area pharmaceutical company that is in high growth mode, is actively recruiting for skilled, knowledgeable and mission-driven Process Development Engineer to assume key role on its Operations team.
Company will pay absolute top dollar to attract and retain a star.
Company boasts unique technology and products that are highly anticipated by both the medical and business communities. As it moves towards commercialization, it is imperative that the company engage exceptional people to drive its production efforts. We seek a Process Development Engineer who brings a keen engineering core that is complemented by astute and practiced business and operational savvy.
Key things to note:
• This is a young company with multiple launches planned. Scale-up and tech transfer experience will be important.
• This is a highly collaborative role. This Engineer will partner with Manufacturing, R&D and QA as well as vendors and independent consultants on scale-up, process optimization, tech transfer and new product development. We seek an astute listener and collaborator.
• 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.
Position will involve providing process development and engineering support for technology transfer, process validation and GMP manufacturing for the company’s drug substance and semi-solid products. Primary responsibility will be to engage in automation and technology development activities within the company to ensure optimal results.
Specific duties will include:
• Design, build, acquire and maintain methods and tools for process improvements.
• Work with R&D and QA in new product scale-up, process optimization, tech transfer and process validation activities
• Perform development and implementation of new process technology
• Perform process design and process simulation studies to support process automation projects
• Develop manufacturing processes and develop process improvements and efficiencies
• 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 product 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
• Ensure successful manufacturing production runs by assessing risk, setting preventative measures, investigating, and troubleshooting equipment and process issues
• Install and maintain process technology equipment such as compressors, pumps, gas panels, reaction vessels, and other operational 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 process chemistry 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 take-charge, get things done leader. A lot is happening. We seek a highly skilled and driven overachiever who will work exceedingly well in a building setting. Growth potential is enormous.
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.
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