Nkere Kanu Ebube, PhD

**** *. ***** ****, ***** Lake, IL 60073

Home: acbltn@r.postjobfree.com Cell:

847-***-**** t 224-***-****

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: acbltn@r.postjobfree.com Cell:

847-***-**** t 224-***-****

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.

Contact this candidate