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Manufacturing Director
at Top Echelon Network in NC (Published at Feb 22 2012)
Job Location: NC
We have been engaged to find a Subject Matter Expert in medical device manufacturing for a North Carolina based opportunity with a leading medical technologies company. Excellent opportunity to make an immediate impact with great company.
The Manufacturing Director will work as a consultant helping Sr Management on the identification and utilization of Contract Manufacturers (CMO) on the scale-up of current products to large scale manufacturing for commercial use.
Responsibilities include:
Work with internal and external departments, vendors and consultants on the final assembly and packaging of commercial product under GMP
Oversight of tech transfer to include troubleshooting of all design, manufacturing and packaging issues
Work with established QA department to design a vendor selection and auditing program
Establish the packaging and logistics program for all vendors and suppliers
Work with the local pilot plant, int'l suppliers and CMO on transfer to large-scale manufacturing
The qualified candidate will have:
BS or MS in Science or Engineering, PhD is a plus
Experience with sterile based manufacturing is requires (aseptic and clean rooms)
Proven, hands on skills with medical device manufacturing
Contract manufacturing site start-up experience
Strong tech transfer knowledge and experience
Ability to comply with all FDA and int'l regulatory standards
Strong written and verbal communication skills
Ability to travel as required
Industry: CMO, Medical Device, Contract Manufacturing, tech transfer, sterile, stent, implants, drug, pharmaceutical, pilot plant, engineering, R&D, science, clean room
We have been engaged to find a Subject Matter Expert in medical device manufacturing for a North Carolina based opportunity with a leading medical technologies company. Excellent opportunity to make an immediate impact with great company.
The Manufacturing Director will work as a consultant helping Sr Management on the identification and utilization of Contract Manufacturers (CMO) on the scale-up of current products to large scale manufacturing for commercial use.
Responsibilities include:
Work with internal and external departments, vendors and consultants on the final assembly and packaging of commercial product under GMP
Oversight of tech transfer to include troubleshooting of all design, manufacturing and packaging issues
Work with established QA department to design a vendor selection and auditing program
Establish the packaging and logistics program for all vendors and suppliers
Work with the local pilot plant, int'l suppliers and CMO on transfer to large-scale manufacturing
The qualified candidate will have:
BS or MS in Science or Engineering, PhD is a plus
Experience with sterile based manufacturing is requires (aseptic and clean rooms)
Proven, hands on skills with medical device manufacturing
Contract manufacturing site start-up experience
Strong tech transfer knowledge and experience
Ability to comply with all FDA and int'l regulatory standards
Strong written and verbal communication skills
Ability to travel as required
Industry: CMO, Medical Device, Contract Manufacturing, tech transfer, sterile, stent, implants, drug, pharmaceutical, pilot plant, engineering, R&D, science, clean room
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