Nigel Smart

Nigel Smart Email and Phone Number

President: Smart Pharmaceutical Consulting, Relationships and Lifestyles; Key-Note speaker @ SMART Pharma Consulting, LLC
West Chester, PA, US
Nigel Smart's Location
West Chester, Pennsylvania, United States, United States
Nigel Smart's Contact Details
About Nigel Smart

Is a Key-note and Motvational speaker and covers Leadership and High performance Habits. For both personal and corporate situations he provides mentoring , group coaching and Masterminds. Is a best selling author in operations, relationship strategies , and divorce.Powerhouse StrategiesWith over 39 years of industry experience, I am dedicated to providing value-added solutions to our pharmaceutical clients’ manufacturing compliance testing and regulatory issues. I love the focus on Compliance and High performance systems. Some of my most prized accomplishments include: 1. Acting as key consultant and VP of operations to re-establish Biothrax production at Bioport after the 9/11 attacks, while producing a vaccine at a 100% success rate during the period of assignment. 2. Designing and patenting novel bioreactors for cell culture products. 3. Establishing one of the only plant cell drug processes. 4. Developing efficient concepts to properly integrate lean upstream and downstream manufacturing operations. I advise companies on Lean efficient opeartions and how to get the best out of their organizations in terms of productivity. These habits, tools and techniques can be applied across all industry operations and individual improvement programs. Available to provide startegies, coaching and training programs for individuals and executives as well . I hold an honor BS in Chemistry from Leicester University (UK), a MS from the Victoria University of Manchester (UK) in Microbial/Fermentation Technology and a PhD in Biochemical Engineering, also at Manchester. I am also a Chartered Chemist, member of Institute of Biology, and a Chartered Scientist. I am a member of the Parenteral Drug Association (PDA), the International Society for Pharmaceutical Engineering (ISPE) and an affiliate of the Institute of Chemical Engineers. . Currently, at Smart Pharmaceutical Consulting, I lead a professional team of consultants through various subject matters including process excellence, quality compliance, regulatory affairs, training, product/process development/manufacturing, laboratory services and project management.Specialties: Fermentation and Cell Culture of vaccines and recombinant products. Lean Biomanufacturing and Lean Laboratory Analysis. Biological and Chemical Countermeasures. Strategic Analysis. Biological Product development and licensure. FDA liaison. Strategy for commercial licensure. Analysis of Chemical and Biological Process capabilities. Assessment of CMO (Contract Manufacturing) capabilities. Quality Systems design. FDA Inspection readiness.

Nigel Smart's Current Company Details
SMART Pharma Consulting, LLC

Smart Pharma Consulting, Llc

View
President: Smart Pharmaceutical Consulting, Relationships and Lifestyles; Key-Note speaker
West Chester, PA, US
Employees:
2
Nigel Smart Work Experience Details
  • Smart Pharma Consulting, Llc
    President: Smart Pharmaceutical Consulting, Relationships And Lifestyles; Key-Note Speaker
    Smart Pharma Consulting, Llc
    West Chester, Pa, Us
  • Smart Pharma Consulting, Llc
    President: Smart Pharmaceutical Consulting, Relationships And Lifestyles; Key-Note Speaker
    Smart Pharma Consulting, Llc Dec 2017 - Present
    Key- note speaker .Performance leader in encouraging the highest level of performance out of company teams. International author and speaker that elevates creative levels in groups to differentiate from the crowd
  • Smart Pharma Consulting, Llc
    President
    Smart Pharma Consulting, Llc Jan 2017 - Present
    Heads-up Life Science Consulting Company providing a range of expertise including, quality, manufacturing and business support. Boutique quality services with added value outcomes that provide strategic and hands-on technical services. Provides superior manufacturing quality and operational efficiency services to the pharmaceutical, biotech, vaccine, Biologics, medical device, and dietary supplements industries; cell systems and device type products such as skin patches and scaffold-based products being developed for regenerative medicine purposes.Manages a team of over 250 Consultants and Associates. Builds selective teams to address client problems and delivers creative, elegant solutions.Has international connections and partnerships in the EU, Middle East, Asia and Central America.Also Provides Business services including brokerage for non-US companies, Costings, Competitive analysis and Due Diligences services. Mixes modern quality system approach, lean process excellence and risk management to drive quality, regulatory compliance and manufacturing quality. Expertise in quality, manufacturing, laboratory operation and design, lean operations, process development, fermentation, cell culture and bioreactor design and operations, regenerative medicine processes.Looks at new processes and operational methodology. Provides key ideas for remediation. Builds quality systems, conducts GMP/PAI audits. Coordinates quality approaches towards third-party oversight. Integrating lean laboratory with lean manufacturing operations.Provides key person expertise in GMP compliance and data integrity. Provides consulting to FDA. Supports interim monitor activities of Federal Trade Commission antitrust group. Authored a book focusing on lean bio manufacturing, available on Amazon.com.
  • Smart Consulting Group, Llc
    Managing Partner
    Smart Consulting Group, Llc 1999 - 2016
    West Chester, Pennsylvania, Us
    Setup Smart Consulting Group LLC in 1999 to support the life sciences sector. Built up a team of over 200 consultants that support a variety of companies; both operational and developmental. Focus on providing key expert assistance to US government and support to both civil and defense programs dealing with chemical and biological countermeasures.Key author on government commissioned report for production of countermeasures threats over the next 25 years.Provides key leadership on all matters lean to drive efficiency processes to drive efficiency into key support activities.Provides leadership on Lean laboratory management and operational design layout for development which facilities. Is an advocate for lean integration of core processes and supporting activities.Provides subject matter expertise in fermentation/cell culture processes in manufacturing for recombinant products/vaccines/cell products. Provides expertise in manufacturing of pharmaceutical products. Provides expertise in lean manufacturing/Lean laboratory systems/lean compliance systems and quality system analysis and build.Supports all aspects of quality program including; release of products, audits, supply management, change management, investigations, risk management etc.
  • Bioport/Emergent Biosystems
    Acting Vp Operations
    Bioport/Emergent Biosystems 2001 - 2002
    Acted as key person for the department of defense for the relaunch and production of the anthrax vaccine that was out of stock pre-/post 9/11/2001. Reorganized manufacturing group restructured the operations and reestablished manufacturing at 100% output. Provided liaison with the Department of Defense, with the internal quality group and with the Bureau of Biologics at the FDA. Testified on progress to CBER director Kathy Zoon on all aspects for the relaunch and pre-approval of the manufacturing facility by the FDA. Coordinated activities associated with the relaunch and pre-approval of the anthrax facility.
  • Inflammatic, Inc.
    Ceo/President
    Inflammatic, Inc. 1995 - 2000
    Sunnyvale, California, Us
    Founded Inflammatics out of Thomas Jefferson Medical College, Philadelphia. Financed cell based allogeneic vaccine therapy (LeukoVAX) for the treatment of rheumatoid arthritis.Obtained technology and built management team obtaining IND within six weeks. Coordinated all aspects of regulatory filing and enrollment of clinical sites for phase 2 clinical trials. Raised capital and developed technology to phase 2 with 100 patients. Partnered with NASDAQ company. Successfully presented results and progress to NASDAQ shareholder meeting.
  • Sterling Winthrop Immuno Conjugates
    Assistant Director Development And Manufacturing
    Sterling Winthrop Immuno Conjugates 1991 - 1993
    Provided management’s leadership for the startup and design of new monoclonal antibody pilot plant for cancer focused biopharmaceuticals. Designed manufacturing strategy to meet aggressive clinical trial schedule for phase 1 testing. Material produced 98% acceptance for specification criteria. Built new pilot production team and trained them in practical aspects of production operation to GMP. Provided significant support for construction of quality system to support clinical production. Lead validation team and developed validation master plan for facility. Hired Fluor Daniels validation group to manage validation program. Managed contractor relationship. Designed new bioreactors manufactured by ABEC manufacturers. Examined bioreactors at build shop and performed acceptance testing prior to shipping. Key member of technical team during scale up.
  • Smithkline Beecham Corporation
    Assistant Director Fermentation Operations
    Smithkline Beecham Corporation 1989 - 1991
    Acted as key manager for the development of targets is to support SmithKline Beecham’s biopharmaceutical business. Included targets and material produced to support clinical trials. Produced material for 21 targets in 18 months including vaccines and therapeutics. Acted as projects executive for new bioreactor program. Member of site safety committee for biopharmaceutical production. Responsible for construction and training of new manufacturing staff which exceeded 25 employees. Responsible for budget and execution of all manufacturing related projects.
  • Allelix Biopharmaceuticals
    Pilot Plant Manager
    Allelix Biopharmaceuticals 1985 - 1989
    Acted as key manager to Canadian start up biotechnology company. Reported to CEO. Oversaw development of fermentation and cell culture capabilities for the production of pharmaceutical products. Developed capabilities for downstream processing and purification of lead drug candidates. Managed the company project for the development of a computerized control system for the process development group. Oversaw the development of the design of the cGMP production plant by Davy McKee engineers. Was responsible for the development of numerous processes for growth factors including SOD, PTH, EGF. Oversaw construction and development and testing of production reactors. Designed Airlift bioreactor to develop cell culture processes for company products. Scaled up and transferred cell culture products for cancer therapy to Japanese pharmaceutical company.
  • Wolfson Biotechnology Institute
    Postdoctoral Fellow / Pilot Plant Manager
    Wolfson Biotechnology Institute 1979 - 1984
    Post-Doctoral Fellow /staff member-Pilot Plant ManagerDevelopment of Cell culture processes for the production of plant-based pharmaceuticals.Designs of Airlift bioreactors and immobilized bioreactors for the production of secondary metabolites.Designed purpose-built pilot plant with 18 bioreactors with computer control and on-line gas analysis. Installed bioreactors to 150 liters including two airlift bioreactors designed for LH Fermentation.Consultant to LH Fermentation for bioreactor designsConsultant to APV International for design of 1000L airlift bioreactor.

Nigel Smart Skills

Pharmaceutical Industry Gmp Biotechnology Fda Quality System Technology Transfer Regulatory Affairs Lifesciences Capa V&v Validation Change Control Medical Devices Quality Assurance 21 Cfr Part 11 Sop Gxp Computer System Validation Quality Management Quality Auditing Microbiology Strategy Regulatory Submissions Clinical Trials Glp Process Simulation Drug Development Biopharmaceuticals Aseptic Processing Pharmaceutics Vaccines Quality Control Gamp Lims Commercialization Iso 13485 Laboratory R&d Purification Cell Analytical Chemistry Manufacturing Clinical Development Ind Regulatory Requirements Cro Lean Manufacturing Cell Culture Chemistry Life Sciences

Nigel Smart Education Details

  • The University Of Manchester
    The University Of Manchester
    Fermentation/Biochemical Engineering Of Novel Beta-Lactam Antibiotics
  • The University Of Manchester
    The University Of Manchester
    Fermentation And Secondary Metabolis M In Streptomyces Species
  • University Of Leicester
    University Of Leicester
    Chemistry

Frequently Asked Questions about Nigel Smart

What company does Nigel Smart work for?

Nigel Smart works for Smart Pharma Consulting, Llc

What is Nigel Smart's role at the current company?

Nigel Smart's current role is President: Smart Pharmaceutical Consulting, Relationships and Lifestyles; Key-Note speaker.

What is Nigel Smart's email address?

Nigel Smart's email address is ns****@****oup.com

What is Nigel Smart's direct phone number?

Nigel Smart's direct phone number is +161034*****

What schools did Nigel Smart attend?

Nigel Smart attended The University Of Manchester, The University Of Manchester, University Of Leicester.

What skills is Nigel Smart known for?

Nigel Smart has skills like Pharmaceutical Industry, Gmp, Biotechnology, Fda, Quality System, Technology Transfer, Regulatory Affairs, Lifesciences, Capa, V&v, Validation, Change Control.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.