Development Quality Assurance
Resume:
Nkere Kanu Ebube, PhD
**** *. ***** ****, ***** Lake, IL 60073
Home: *****.****@***.** Cell:
PHARMACEUTICAL SCIENCES EXECUTIVE
FORMULATION DEVELOPMENT TECHNICAL OPERATIONS QUALITY ASSURANCE CMC
SUBMISSION
Senior Director with expertise leading new product development and
technology transfer for small molecules and biologics. Over 18 years'
experience developing various dosage forms including oral solids, liquids,
semi-solids, and parenterals (sterile products) for branded, generic, and
OTC products. Known for ability to direct complex programs and
consistently achieve deliverables for scope, time and budget. Creates a
culture of regulatory compliance and customer-service.
. Formulation Development: Expertise in oral controlled release technology
and bio-enhancement techniques. Led development of Tramadol ER,
Venlafaxine ER, Ultram ODT, etc.
. Scale up and Technology Transfer: Led scale-up and technology transfer of
several generic, branded, OTC, and biologics pharmaceutical products,
e.g. EMBEDA (abuse resistant controlled release opioid).
. CMC Submission: Global Expansion core team leadership directing over 130
submissions across LATAM, EMEA, MEENA, APAC. Developed PAI strategy and
compliance to global and regional standards.
. Business Development, Scientific Affairs: Actively drove new project
identification, initiation, product portfolio review and strategic
planning resulting in over 40 active projects.
. Controlled Substance, DEA Compliance: Initiated and executed program
evaluating surrogates for opioid agonist and antagonist resulting in
improved process, scale up and technology transfer with cost saving of
over $2M and enhancement of product development lead time.
. Quality Assurance and Compliance: Provided technical, quality and
compliance oversight for generic injectable and biologics products, e.g.
Linezolid, Dyloject, Daptomycin injection, Infliximab, Aztreonam.
PROFESSIONAL EXPERIENCE
HOSPIRA, INC., Lake Forest, IL 2011 - Present
A US-based global generic pharmaceutical & medical device company with
approximately 15,000 employees
Director, Drug & Biologics New Product Quality & Technology Transfer
Supported new product development and technology transfer for drug and
biologics, providing technical, compliance and quality oversight to ensure
development of high quality pharmaceutical products. Managed 8 New Product
Quality and Technology Transfer Managers and annual budget of over $1.5M.
. Provided leadership for development of robust technology transfer process
for generic injectable, proprietary, API and biologics pharmaceutical
products.
. Supported development and regulatory submission of generic injectable
products, including pre-submission executive reviews. Received
commendation from Senior Regulatory Affairs Management for thorough CMC
reviews, e.g. Ertapanem injection.
. Received executive commendation for role as part of a team selected to
address acute drug shortage issues for multiple oncology drugs.
. Key player of the Biologics Specification committee setting
specifications for EPO, Proprietary & Life-cycle management teams, and
joint venture steering committee with Celltrion for development of
Infliximab.
. Key contributor to Global Expansion Program resulting in over 130
submissions across the world under 2 years - strategic direction,
compliance remediation, in-country release strategy, PAI readiness, etc.
Nkere Kanu Ebube, PhD - Page 2 of 3
PADDOCK LABORATORIES, Minneapolis, MN 2010 - 2011
A privately held generic drug manufacturing company acquired in 2011 by
Perrigo Company.
Director, Formulation & Process Development
Led internal/external projects including development of immediate release,
controlled release, parenteral, topical, liquids and semi-solid generic
dosage forms. Supported regulatory submissions, business development,
operations, & clinical development. Managed 16 technical personnel and 3
R&D Managers.
. Actively involved in new project identification, initiation, product
portfolio review, and strategic planning as member of scientific affairs
steering committee resulting in over 40 active projects.
. Provided leadership for the successful development and ANDA filing of
several IR, CR, topical, and parenteral products. Led the development of
over 30 new ANDA projects.
. Effectively streamlined roles and responsibilities, and eliminated
redundancies resulting in increased output in terms of number of projects
and ANDA filings for internal and external projects.
. Core member of senior leadership team charged to review and integrate
R&D, Operations and Manufacturing processes to enhance efficiency and
throughput. Completed task ahead of schedule.
ALPHARMA PHARMACEUTICALS LLC, Piscataway, NJ 2007 - 2009
A Specialty Pharmaceutical Company and leader in pain treatment market
acquired by King /Pfizer in 2008.
Director, Technical Operations
Key leader for establishment, qualification and operation of R&D pilot
plant, scale up and technology transfer of new and existing products to 3rd
party commercial manufacturing sites, and supported regulatory submissions
and business development programs. Managed 5 senior process engineers, a
technical operation technician, and a manager.
. Actively participated in the review of Alpharma / King Pharmaceuticals
product portfolio, and functional integration of corporate operations
following merger of the 2 companies.
. Provided leadership for the successful technology transfer and validation
of EMBEDA , extended release morphine sulfate capsules with abuse
deterrent properties.
. Initiated and successfully executed program for evaluation of surrogates
for opioid agonist and antagonist, resulting in improved process, scale
up and technology transfer with cost saving of over $2M.
. Received sNDA approval for an extended release capsules, and supported
successful NDA filing for a controlled release capsule based on abuse
deterrent technology platform.
. Initiated New Product Concept and Technology Platform to secure core
products franchise, seek opportunities for IP protection, identify new
technologies and enhance corporate product portfolio.
BIOVAIL TECHNOLOGIES, Chantilly, VA 2005 - 2007
A Specialty Pharmaceutical Company with focus on niche CNS market. Merged
with Valeant in 2010.
Associate Director, Formulation Development
Led development of over 10 NDAs oral controlled release dosage forms
(including combination products), manufacture of clinical supplies, and
closely interfacing with IP, business development, CMC, and bio-
pharmaceutics groups. Managed 12 scientists including an R&D Manager and a
Sr. Spectroscopy Scientist.
. Provided leadership for successful completion of 8 phase-1 studies from
concept to pilot PK studies within 11-month period, e.g. Venlafaxine HCl
ER tablets, Ultram ER (pediatrics & life-cycle management)
. Achieved aggressive timeline to develop an ANDA product with strong IP
potential within 5 weeks; pivotal scale, bio-study and ANDA filing was
targeted for 2Q07.
. Inaugurated cross-functional strategic planning tools to speed up product
development process. Generated templates to improve quality of technical
documents and submission reports.
Nkere Kanu Ebube, PhD - Page 3 of 3
MORTON GROVE PHARMACEUTICALS, INC., Vernon Hills, IL 2004 - 2005
Director, Oral Controlled Release Technologies
Established the oral controlled release and the liquid companion programs
(infrastructure, personnel and selection of product portfolios), supervised
the core product group, and coordinated R&D Stability / DEA programs.
Managed up to 10 scientists - 8 PhDs and 2 MS scientists.
. Provided leadership for reformulation and scale-up of phenytoin oral
suspension resulting in improved process and product attributes.
. Initiated and supervised development of 3 ANDAs and 1 NDA oral controlled
release liquids products - including generation of CMC technical
documents, and identification of commercial manufacturing sites.
WYETH CONSUMER HEALTHCARE, Richmond, VA 1998 - 2004
R&D MANAGER, Formulation Development 2001 - 2004
Managed development of various liquids, semi-solid and solid dosage forms
from concept to commercialization, including identification of
manufacturing sites, and technology transfer. Managed team of scientists,
technicians and technical writers. Recipient of Wyeth Consumer Healthcare
Service Award.
. Led a team of scientists to develop over 30 new solid dosage forms and
softgel products from product design, lab-scale to commercialization /
launch phases. All products were launched on schedule.
. Filed 2 patent applications on nano-particulate technology and novel
chewable matrix.
. Led the development and launch of 2 Robitussin liquid products, 2 cough
drops, Prep H product, Chapstick, dextromethorphan cough gels, IND for a
suspension product, etc.
PREVIOUS POSITIONS
. Principal Scientist, Wyeth Consumer Healthcare, 2000 - 2001
. Senior Scientist, Wyeth Consumer Healthcare, 1998 - 2000
. Florida A&M University, Professor of Pharmaceutics, 1996 - 1998
. University of Tennessee, Postdoctoral Fellow, 1994 - 1995
EDUCATION & CREDENTIALS
Ph.D, Pharmaceutics, University of Mississippi, Oxford, Mississippi
M. Pharm, Pharmaceutics, University of Nigeria, Nsukka, Nigeria.
B. Pharm, Pharmacy, University of Nigeria, Nsukka, Nigeria.
Professional Development courses or certifications
. Foundation of Leadership, Center for Creative Leadership, San Diego, CA
. Program on Technology Negotiation, A University Consortium, Harvard
University, MIT & Tufts University
. Fundamentals of Finance for Technical Executive, Sloan School of
Management, MIT
Professional Affiliations
. American Association of Pharmaceutical Scientists (AAPS), American
Association of Colleges of Pharmacy (AACP), Controlled Release Society
(CRS)
. Adjunct Professor of Pharmaceutics & Pharmaceutical Technology, Florida
A&M University, Tallahassee, FL, and Roosevelt University, Chicago, IL
. Chairman of the Board, NANI-USA (2005-2008), National President, NANI-USA
(2008-2012).
. Member of the Board, Nigeria Association of Pharmacist & Pharmaceutical
Scientists in America (NAPPSA) (2007- Present).
. President Elect, NAPPSA. 2013 - Present.
Nkere Kanu Ebube, PhD
2376 S. Arden Lane, Round Lake, IL 60073
Home: *****.****@***.** Cell:
APPENDIX
PUBLICATIONS / PRESENTATIONS
. N.K. Ebube. "Malaria: A Disease yet to be Conquered," Pharmanews, vol.
13, no. 1, January 1991.
. N.K. Ebube, O.K. Udeala and A.A. Ghobashy. "Isolation and
Characterization of a Novel Polysaccharide from Bacillus licheniformis
NCIB 11634," J. Ind. Micro., 9, 239-245 (1992).
. N.K. Ebube, A. Hikal, C. Wyandt, C. Beer, L. Miller and A.B. Jones.
"Effect of Drug, Formulation and Process Variables on Granulation and
Compaction Characteristics of Heterogeneous Matrices: Part 11. HPMC and
PVP Systems," Drug Dev Ind. Pharm. 22 (7), 561-567 (1996).
. N.K. Ebube, A. Hikal, C. Wyandt, C. Beer, L. Miller and A.B. Jones.
"Sustained Release of Acetaminophen from Heterogeneous Matrix Tablets:
Influence of Polymer Ratio, Polymer Loading, and Co-active on Drug
Release," Pharm. Dev. and Technol., 2 (2), 161-171 (1997).
. N.K. Ebube, T. McCall, Y. Chen and M.C. Meyer. "Relating Formulation
Variables to In Vitro Dissolution Using an Artificial Neural Network,"
Pharm. Dev. and Technol., 2(3), 1-8 (1997).
. G. Owusu-Ababio, S. Onyilofor, M. Habib and N.K. Ebube. "Formulation
Characteristics of Ofloxacin Microspheres for the Treatment of
Osteomylitis," Proceed, Int. Symp, Controlled Rel. Bioact. Mater, 24:
783784 (1997).
. N.K. Ebube, A. Hikal, C. Wyandt, C. Beer, L. Miller and A.B. Jones.
"Effect of Drug, Formulation and Process Variables on Granulation and
Compaction Characteristics of Heterogeneous Matrices: Part 1. HPMC and
HPC Systems," Int. J. Pharm., 156, 49-57 (1997).
. G. Owusu-Ababio, N.K. Ebube, R. Reams and M. Habib. "Comparative
Dissolution Studies for Mefenamic Acid-Polyethylene Glycol Solid
Dispersion Systems and Tablets," Pharm. Dev. and Technol., 3, 405-412
(1998).
. N.K. Ebube, A.J. Shukla, S.S. Thorsar, R. Roberts, M.S. Kemper, D. L.
Martin, G. E. Reier and T.A. Wheatley. "Application of Near Infrared
Spectroscopy (NIRS) for Non-Destructive Analysis of Avicel( Powders and
Tablets," Pharm. Dev. and Technol., 4, 19-26 (1999).
. M. Habib, S. Onyilofor, N.K. Ebube and G. Owusu-Ababio. "Preparation and
Characterization of Ofloxacin Microspheres for the Eradication of Bone
Associated Bacterial Biofilm," J. Microencapsulation, 16: 27-37(1999).
. N.K. Ebube, G. Owusu-Ababio and C.M. Adeyeye. "Preformulation Studies
and Non-destructive Characterization of the Physicochemical Properties of
Amorphous Polymers using Artificial Neural Networks," Int. J. Pharm.,
196: 27-35 (2000).
. Q. Yang, D. Williams, G. Owusu-Ababio, M.J. Habib and N.K. Ebube.
"Controlled Release Tacrine Delivery System for the Treatment of
Alzheimer's Disease," Drug Delivery, 8: 93-98 (2001).
. N.K. Ebube, H. Hahm and W. Mark. "Preformulation Studies and
Characterization of Two Chondroprotective Agents: Glucosamine HCl and
Chondroitin Sulfate," Pharm. Dev. And Technol., 7 (4), 457-469 (2002).
. N.K. Ebube and A.B. Jones. "A Sustained Release of Acetaminophen from
Heterogeneous Mixture of Two Hydrophilic Non-Ionic Cellulose Ether
Polymers", Int. J. Pharm. 272, 19-27 (2004).
. N.K. Ebube and A.B. Jones. "Preformulation Studies of Heterogeneous
Matrices as Drug Delivery Carriers using a Mixture of HPMC and HPC or
PVP", (unpublished article).
Nkere Kanu Ebube, PhD - Page 2 of 4
APPENDIX (Continued)
. N.K. Ebube, A.J. Shukla, S.S. Thorsar, R. Roberts, M. Lyles, G. E. Reier
and Wheatley. "Effect of Different Lubricants on Compression Properties
of Various Grades of Avicel(," (unpublished article).
. N.K. Ebube, W. Wilson, W. William, A. Usayapant, C. Summitt, C. Kish and
N. Partridge. "Effects of Drug, Processing and Formulation Variables on
Release from Matrix Tablets Containing HPMC and Chondroitin Sulfate,"
(unpublished article).
BOOK / BOOK CHAPTER
. N.K. Ebube. "Intelligent Preformulation Design and Predictions using
Artificial Neural Networks" in: Preformulation in Solid Dosage Form
Development, M.C. Adeyeye and H.G. Brittain, eds., Informa Health Care,
NY, pages 81 - 114 (2008).
. Nkere K. Ebube. Standing Tall: Finding Strength and Peace during Crisis
or Storms of Life, Westbow Press, IN (2012).
ABSTRACTS
. "Evaluation of the Effect of Different Lubricants on the Compression
Characteristics of Various Grades of Avicel(", N.K. Ebube, A.J. Shukla,
S.S. Thorsar, R. Roberts, M. Lyles, G. Reier and T. Wheatley. Presented
at the American Association of Pharmaceutical Scientist (AAPS) Conference
in Miami, Florida, November 1995.
. "Non-Destructive Determination of Tablet Crushing Strength and Lubricant
Concentration using Near Infrared Spectroscopy", N.K. Ebube, A.J. Shukla,
S.S. Thorsar, R. Roberts, D. Martin, M. Kemper, G. Reier and T. Wheatley.
Presented at the American Association of Pharmaceutical Scientist (AAPS)
Conference in Miami, Florida, November 1995.
. "Application of Artificial Intelligence to Pharmaceutical Product
Development: A Systematic Approach to the Selection of Training Data",
N.K. Ebube, M.C. Meyer and T. McCall. Presented at the American
Association of Pharmaceutical Scientist (AAPS) Conference in Miami,
Florida, November 1995.
. "Non-Destructive Analysis of Physical and Chemical Characteristics of
Tablets by Near Infrared Transmission Spectroscopy", R.L Rubinovitz, W.
M. Trygstad, A.J. Shukla, N. K. Ebube, G. E. Reier and T.A. Wheatley.
Presented at the Eastern Analytical Symposium (EAS), Somerset, NJ,
November 1995.
. "Effect of Varying Concentrations of Different Lubricants on Compression
Characteristics of Various Grades of Avicel(, R. Roberts, S. S. Thorsar,
A. J. Shukla, N. K. Ebube, G. E. Reier and T.A. Wheatley. Presented at
the American Association of Pharmaceutical Scientist (AAPS) Conference in
Seattle, Washington, October 1996.
. "Non-Destructive Determination of Drug Content in Intact Tablets Using
Near Infrared Spectroscopy", S.S. Thorsar, R. Roberts, A.J. Shukla, N.K
Ebube, R.L. Rubinovitz, M.Kemper, G.E. Reier and T. A. Wheatley.
Presented at the American Association of Pharmaceutical Scientist (AAPS)
Conference in Seattle, Washington, October 1996.
. "Non-Destructive Characterization of the Physicochemical Properties of
Amorphous Polymers Using the Artificial Neural Networks", N.K. Ebube, G.
Owusu-Ababio and R.G. Alamo. Presented at the American Association of
Pharmaceutical Scientist (AAPS) Conference in Seattle, Washington,
October 1996.
. "Formulation Characteristics of Ofloxacin Microspheres for the Treatment
of Osteomylitis", G. Owusu-Ababio, S. Onyalifor, M. Habib and N.K. Ebube.
Presented at the Controlled Release Society Meeting, Stockholm, Sweden,
June 1997.
Nkere Kanu Ebube, PhD - Page 3 of 4
APPENDIX (Continued)
. "Formulation and Optimization of Encapsulation Efficiency of Monensin
Liposomes Using the Artificial Neural Networks", N.K. Ebube, S.
Bennefield, A.J. Ferdous and M. Singh. Presented at the American
Association of Pharmaceutical Scientist (AAPS) Conference in Boston,
Massachusetts, November 1997.
. "Data-Driven Design of Experiments Using Artificial Intelligence:
Implication for Formulation Development", N.K. Ebube, G. Owusu-Ababio and
C.M. Adeyeye. Presented at the American Association of Pharmaceutical
Scientist (AAPS) Conference in Boston, Massachusetts, November 1997.
. "Optimization of Pharmaceutical Unit Operations Using the Artificial
Neural Networks". N.K. Ebube and C.M. Adeyeye. Presented at the
American Association of Pharmaceutical Scientist (AAPS) Conference in
Boston, Massachusetts, November 1997.
. "Poly (Glycolic Acid-Co-DL-Lactic Acid) Microspheres of Enoxacin for
Treatment of Bacterial Biofilm Infections", G. Owusu-Ababio, N. K. Ebube,
S. Ademuyiwa, M. Sachdeva and M.J. Habib. Presented at the American
Association of Pharmaceutical Scientist (AAPS) Conference in Boston,
Massachusetts, November 1997.
. "Biodegradable Amoxicillin Microparticles for Treatment of Bacterial
Biofilm." M.J. Habib, S. Onyilofor, N.K. Ebube, G. Owusu-Ababio.
Presented at the American Association of Pharmaceutical Scientist (AAPS)
Conference in Boston, Massachusetts, November 1997.
. "Prediction of Tablet Drug Content and Hardness using the Artificial
Neural Network (ANN) and Near-Infrared Spectroscopy (NIRS)." Yixin Chen,
S.S. Thosar, R.A. Roberts, M.S. Kemper, R. Rubinovitz, N.K. Ebube and
A.J. Shukla. Presented at the American Association of Pharmaceutical
Scientist (AAPS) Conference in San Francisco, California, November 1998.
. "Biodegradable Progesterone Delivery System for Osteoporosis Therapy."
Godfried Owusu-Ababio, Qing Yang, Nkere Ebube, and Muhammad Habib.
Presented at the American Association of Pharmaceutical Scientist (AAPS)
Conference in San Francisco, California, November 1998.
. "Effects of Drug, Processing and Formulation Variables on Release from
Matrix Tablets Containing HPMC and Chondroitin Sulfate." N.K. Ebube, W.
Wilson, W. William, A. Usayapant, C. Summitt, C. Kish and N. Partridge.
Presented at the American Association of Pharmaceutical Scientist (AAPS)
Conference in Denver, Colorado, October 2001.
. "Preformulation Studies and Characterization of Two Proposed
Chondroprotective Agents: Glucosamine HCl and Chondroitin Sulfate."
N.K. Ebube, W. William and H. Hahm. Presented at the American
Association of Pharmaceutical Scientist (AAPS) Conference in Denver,
Colorado, October 2001.
. "Optimization of Sustained Release Matrix Tablet Formulations Containing
HPMC and Chondroitin Sulfate Using Artificial Neural Networks (ANNs)."
N.K. Ebube, Wendy I. Wilson and Neil Partridge. Presented at the
American Association of Pharmaceutical Scientists Annual Conference,
Toronto, Canada (November 2002).
. "Comparison of Statistical and Artificial Neural Network Methods for
Formulation Optimization: Application to Sustained Release Matrix
Tablets Containing Carrageenan and Sodium Alginate." N.K. Ebube, Wendy
I. Wilson and Neil Partridge. Presented at the American Association of
Pharmaceutical Scientists Annual Conference, Toronto, Canada (November
2002).
. "Effect of pH on the Physical and Rheological Properties of Avicel-
Xanthan Suspensions." N.K. Ebube, Lili-Wang-Tsang, Hanife Akin, Sandra
Jordan, Kenneth Hall, and Todd Koch. Presented at the American
Association of Pharmaceutical Scientists Annual Conference, Toronto,
Canada (November 2002).
. "Effect of Aging and Temperature on the Physical and Rheological
Properties of Avicel-Xanthan Suspensions." N.K. Ebube, Lili-Wang-Tsang,
Hanife Akin, Sandra Jordan, and Todd Koch. N.K. Ebube, Lili-Wang-Tsang,
Hanife Akin, Sandra Jordan, and Todd Koch. Presented at the American
Association of Pharmaceutical Scientists Annual Conference, Toronto,
Canada (November 2002).
Nkere Kanu Ebube, PhD - Page 4 of 4
APPENDIX (Continued)
. "Solubility of Dextromethorphan in Non-Aqueous Solvents." P.T. Mayer,
J.W. Hutcheson, J.N. Phillips, N.K. Ebube and T.S. Koch. Presented at
the American Association of Pharmaceutical Scientists Annual Conference,
Toronto, Canada (November 2002).
. "Preformulation Studies and Prediction of Dosage Form Performance Using
Artificial Neural Networks - Case Studies." N.K. Ebube, Wendy Wilson and
Neil Partridge. Presented at the American Association of Pharmaceutical
Scientists Annual Conference, Salt Lake City, Utah (October 2003).
INVITED PRESENTATIONS
. "Preformulation Studies of Matrix-Type Sustained Release Tablets,"
Presented at TIMERX Technologies, Patterson, NY, January 1995.
. "Systematic Approach to Design and Optimization of Pharmaceutical Dosage
Form using Neural Networks," Presented at TIMERX Technologies, Patterson,
NY, July 1995.
. "Drug Release for Swelling Polymeric Matrix Devices," Presented at
Department of Chemical Engineering, FSU / FAMU School of Engineering,
Tallahassee, Florida, November 1996.
. "Formulation Modeling and Optimization with Neural Networks," Presented
at Pharmaceutical Unit Processes and Solid Dosage Form Development
Workshop, Duquesne University, Pittsburgh, PA, May 27-31, 1997.
. "Future of Pharmacy Education: Impact on Pharmaceutical Industry,"
Presented at Sanofi Research, Philadelphia, PA, August 1997.
. "Application of Artificial Neural Networks in Formulation Development,"
Presented at Sanofi Research, Philadelphia, PA, August 1997.
. "Application of Artificial Intelligence in Pharmaceutical Product
Development," Presented at University of Florida, Gainesville, FL,
October 1997.
. "Neural Network and Prediction of Tablet Dosage Form Performance - Case
Study," Presented at Pharmaceutical Unit Processes and Solid Dosage Form
Development Workshop, Duquesne University, Pittsburgh, PA (May 18-21,
1998 and May 24-28, 1999).
. "Prediction of Dosage Form Performance using Artificial Intelligence -
Case Studies," Presented at MCV College of Pharmacy, Richmond, VA
(January 2002).
. "Outsourcing of Pharmaceutical Development: A Managed Risk-Based
Approach to Improve Lead Times," Nigerian Association of Pharmacists and
Pharmaceutical Scientists in America (NAPPSA), Houston, TX, September 14-
16, 2007.
. "Best Practices for Improving Lead Time of Technology Transfer to
Contract Manufacturing Organization," Quality and Lean Conference, Milan,
Italy, May 2008.
. "Functional Overview & Rational Product Development Strategy," Paddock
Laboratories, 2011.
. "Pharmaceutical Quality by Design: A Risk-based Approach to Improve
Development Lead Time," Hospira, 2011.
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