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Manufacturing Manager, Drug Products (Ophthalmic/Plastic Components)–Top$
RTP, NC 27709 United States
Manufacturing and Production
Our client, a rapidly-expanding RTP-based biotech that is developing a portfolio of ophthalmic products, is actively recruiting for a highly skilled Manufacturing Manager with particular expertise in sterile manufacturing to assume key role on its Operations team. Company relies heavily upon third party vendors for its manufacturing. Right candidate will have extensive experience with this outsourced model.
This is one of the fastest growing companies in the Triangle, and it is nearing the commercialization of multiple products. It is essential that top-notch people are in place to drive production. Seek hands-on, “make-things-happen” candidate who will work exceedingly well in this emerging business setting. Launch experience would be valuable.
The company is developing/manufacturing ophthalmic eye drops. Experience with the sterilization of plastic components is strongly preferred. Sterile manufacturing is a must.
This Manager will be responsible for supporting the development, manufacture and global supply of clinical and commercial drug products including overseeing 3rd party transfer and scale-up. Specific duties will include:
• Oversee manufacturing for clinical and commercial drug products at third party contract research and manufacturing organizations, including campaign planning, coordinating material requirements and oversight of production runs
• Assist in the assessment and selection of third-party manufacturers and contract laboratories
• Manage technology transfer, process development, optimization and validation of drug product manufacturing operations
• Monitor vendor performance and manage vendor relationships to maximize cooperation and optimize quality and performance
• Provide technical support for commercial products, including investigations of deviations and technical troubleshooting
• Contribute to authoring CMC sections of regulatory filings
• Provide input to the development of manufacturing plans, budgets and timelines
• Ensure that all activities are conducted in compliance with regulatory requirements
This is an independent contributor role that will be involved in leading cross-functional teams. Seek collaborator who has a history of developing positive, symbiotic relationships with internal and external stakeholders.
This Manager will simultaneously drive the manufacture of multiple drug products. Seek superb Project Manager with demonstrated ability to effectively plan and manage numerous projects – with sometimes conflicting timelines, budgets and resource needs.
Travel is estimated at <25% (mostly North America).
Ideal candidate will offer a related scientific degree and 6+ years of increasingly responsible experience in pharmaceutical technology, including substantial experience in a sterile manufacturing setting. Experience with the sterilization of plastic components strongly preferred. Other priorities include:
• Experience driving new product launches including validation, tech transfer and scale up
• Bkgd working with CMOs in a high expectations setting
• Demonstrated ability to engage and lead cross-functional teams
• Outstanding project management skills
• Working knowledge of formulations, manufacturing, packaging, and analytical testing
• Knowledge of ophthalmic products and/or controlled release formulations both desirable
Finally and critically, we seek a candidate who will thrive in this emerging setting. A process improvement-focused candidate who enjoys developing the blueprint for a growing operation. The future is very bright. We seek a candidate who will contribute and thrive.
Compensation will be generous and include an industry-leading base, bonus and benefits. Local candidates are preferred.
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