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30 plus years in manufacturing of industrial proteins and biologics. Experience with upstream and downstream processing equipment, automation systems, team building and training. I was also a member or 5 facility startup projects. Experience interfacing with Quality teams, Engineering teams and contractors and vendors.I started my career working in industrial biotechnology at Eastman Kodak., then to Covance Biotech (Diosynth RTP N.C.), then to Wyeth in Sanford NC which became Pfizer in 2010. I was a manufacturing supervisor, was a mfg liaison with engineering and Quality during a new facility project for manufacturing. I was responsible for making sure equipment was built for manufacturing technicians to operate the equipment within specification. Examples of responsibilities: created/reviewed functional requirements for equipment the Delta V process control system, perform engineering start up tests, commissioning and validation of the equipment. I have been part of technology transfer teams and regulatory audit preparation teams to review protocols and submission documents for what have been successful audits by the FDA and other National Boards of Health. As a Quality scientist I worked with the shop floor to fix/find and implement corrective actions for process concerns and deviations.I bring the understanding that a technician would have been on the process floor as well as the experience of a supervisor. At Eastman Kodak I worked on process improvement and technology which is consistent with a production need to manufacture a quality product today in the changing biotech environment.I wish to grow as a business professional utilizing my past experiences and grow with new challenges.I have been a part of Grifols where blood plasma is fractionated and purified for medicines and some time at a CDMO facility start up.
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Sr Commissioning Specialist35 North Feb 2023 - PresentDurham, Nc, Us -
Associate DirectorKbi Biopharma Oct 2021 - Sep 2022Durham, North Carolina, Us -
Manager Downstream ManufacturingKbi Biopharma Apr 2021 - Oct 2021Durham, North Carolina, Us
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Senior Manufacturing SupervisorKbi Biopharma Jan 2021 - Apr 2021Durham, North Carolina, Us
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Manufacturing SupervisorGrifols Biotheraputics Inc. Jun 2011 - Jan 2021Sant Cugat Del Vallès, Barcelona, EsParticipating in the construction and start up of the North Fractionation Facility as Talecris has been bought out by Grifols. Hiring, training personnel to operate the plama fractionation facility -
Manufacturing SupervisorTalecris Biotherapeutics, Inc. Mar 2011 - Jan 2021Research Triangle Park, Nc, UsWork with managment and others to start up a new blood products manufacturing facility. -
Manufacturing Quality ScientistPfizer Jan 2010 - Nov 2010New York, New York, Usperformed process investigations with Quality group review for product release, assisted the floor supervisor with issues/ concerns with floor operations -
Manufacturing Senior SupervisorPfizer Nov 1999 - Dec 2009New York, New York, UsSupervise, manage and mentor a team of technicians and supervisors in the manufacture a commercial product. I was part of an engineering team that designed, built, commisioned and validated a new manufacturing facility on the property. The work also included attending FAT for the equipment and process control system (DeltaV). Additionally I have been an individual contributor for process improvement projects to create lean manufacturing and operational excellance.
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Mfg SupervisorCovance Jun 1996 - Nov 1999Princeton, New Jersey, UsParticipated in construction oversite, commissioning, validation and cell culture system clinical material production as a contract manufacturing facility. -
Mfg TechGenencor International Oct 1993 - Oct 1995Rochester, Ny, UsPerformed technology transfer from development scale to manufacturing scale of biological products. Also manufactured products used for industrial applications derived from microbial and fungal fermented processes. -
Mfg TechEastman Kodak Aug 1986 - Oct 1995Rochester, New York, Usworked in the microbiology and chemistry labs perfoming process testing, microbial cultures for manufacturing processes.
John Nugent Skills
John Nugent Education Details
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University Of Maryland University CollegeBiotechnology Studies -
Suny Polytechnic InstituteBiology
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Monroe Community CollegeBiology
Frequently Asked Questions about John Nugent
What company does John Nugent work for?
John Nugent works for 35 North
What is John Nugent's role at the current company?
John Nugent's current role is Bio tech/ commissioning professional.
What is John Nugent's email address?
John Nugent's email address is nu****@****uth.net
What is John Nugent's direct phone number?
John Nugent's direct phone number is +191990*****
What schools did John Nugent attend?
John Nugent attended University Of Maryland University College, Suny Polytechnic Institute, Monroe Community College.
What skills is John Nugent known for?
John Nugent has skills like Validation, Fda, Technology Transfer, Biotechnology, Gmp, Microbiology, Biopharmaceuticals, Aseptic Processing, Change Control, Manufacturing, 21 Cfr Part 11, Team Building.
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