Manager Development

REMIGIUS A. NNODIMELE, Ph.D.

**** ***** ***** ● Macungie, PA 18062● Cell: 973-***-**** ●

********@***.***

SUMMARY OF EXPERTISE

Have expertise in Polymorphic characterization. Patent Specialist and Projects Manager, Manager Analytical R&D, Analytical/Physical Chemist, with more than fifteen years of pharmaceutical industry experience in patent and portfolio issues and analytical development. Provided company asset/intellectual property protection and supported formulations through Polymorphic characterization of drug substances and drug products. Provided technical and analytical support in, early initiation of projects and technical transfer operations. Developed and validated methods, managed a group developing and validating methods, in addition to other CMC functions, ensuring cGMP compliance and prompt FDA submissions. Directed Analytical developments by contract laboratories, reviewed stability data and set specifications, Other responsibilities included, formulation process legal clearance, API clearance, Patent reviews, Reviews of Patent landscapes and Patent Opinions. Proactively, managed FDA Chemistry and Bioequivalence deficiencies. Experienced in Electrochemistry and electrochemical methods and has co-authored over 14 publications. People skilled and was asked to mentor and coach difficult to manage staff members.

COMPUTER/DATABASE SKILLS

Microsoft Office (Excel, Word, Power Point, Adobe Acrobat), Millenium/Empower, Electronic Documentation System (Empower, GxPharma, Wisdom), PAIR, ParagraphIV.com, UMMR, OB and OB Companion, Opinion Database, IPPO Database.

LABORATORY/INSTRUMENTATION SKILLS

Separation Techniques:

HPLC, LC/MS, GC, GC/MS

Spectroscopic, Electrochemical, Thermal, Dissolution, Techniques:

MS, UV, FTIR, NIR, XRD (Powder diffraction, Fluorecense), Electrochemical (Voltammetry, Coulometry, Amperometry), Thermal (TGA, DSC), Particle Size Distribution(Dry, wet), Dissolution (Apparatus I, II, III)

EXPERIENCE

TEVA PHARMACEUTICALS, USA, HORSHAM, PENNSYLVANIA 2009-2011:

Patent Specialist, Pre-Litigation Group, Legal DepartmentReviewed API process and compound chemistry and conducted polymorphic evaluations in support of API clearance.

REMIGIUS A. NNODIMELE, Ph.D.

Conducted formulation clearance process in support of R&D injectable products and solid dosage products development, and for other R&D organizations, and other third party development partners.Communicated with outside counsels and development partners and manufacturers in order to obtain a successful legal clearance for product development. Participated in the patent and patent applications review and tracking process.Completed full patent landscapes in conjunction with outside counsels and completed the landscape opinion review within the stipulated time.

TEVA PHARMACEUTICALS, USA, SELLERSVILLE, PENNSYLVANIA 2007-2009:

Manager, Analytical Research & DevelopmentConducted Polymorphic characterization of drug substances and polymorphic testing of

finished product and stability samples, supporting product development and patent/legal departments.Developed and validated methods, managed a group of chemists involved with Analytical Development and validation, for timely FDA submissionsMentored and coached difficult-to manage staff members transferred to my group.Managed Analytical development and validation by CROs(for projects lacking in-house capabilities)Managed proactively, FDA CMC and Bioequivalence deficiencies and response.Involved with method transfers from the analytical lab. to the QC lab.

Ivax (a subsidIary of teva) Pharmaceuticals, Inc. - Northvale, New Jersey.2003-2007

Group Leader/Special Projects Leader

API CharacterizationConducted Polymorphic evaluations and characterization of drug products and drug substances by XRD, FTIR, NIR, TGA & DSC.Streamlined analytical methods development and validation that resulted in quicker submission times.Reviewed stability data, setting specificationsConducted Particle size evaluation of Active Pharmaceutical Ingredients (APIs)Determined unknown impurities/degradants using LC/MS.Initiated early projects through material characterization.Conducted in-house reference standard characterization and qualifications.Evaluated stability data and set specifications

REMIGIUS A. NNODIMELE, Ph.D.

Method Development/Validation/DeficienciesMethods development, Pre-validation/validation studies for projects slated for NDA and ANDA submissions.Supervised analytical methods development and validation procedures.Conducted FDA, CMC deficiencies response; methods validation, modifications, optimization, amendments of ANDA submissions.Made weekly Presentations to regulatory on CMC issues and FDA deficiencies, liaised with QA and regulatory, for timely resolution.Reviewed Specifications, Chemistry re-evaluations, Toxicity evaluations etc

Other ResponsibilitiesEvaluated new technologies and made presentations, justifications and recommendations to the department. Recommendations on envisaged difficulties of projects to Analytical R&D, in terms of project timeline and resourcesLiaised with outside testing laboratories and contract laboratories. Recommended methods, equipments, etcCoordinated laboratory workload with other groups to maximize laboratory resourcesConducted training in laboratory instrumentation and procedures such as HPLC, FTIR, FTNIR, XRD, TGA, DSC, LC/MS, USP APP I, II, III etc.SOP writing, review and trainingConducted method transfer to manufacturing sites in Americas & Europe, and evaluated CRO Labs.Supervised and conducted performance evaluation of up to 5 direct reports, evaluated potential candidates for AR&D.Prepared weekly reports on issues, investigations, OOS, OOT, resources, personnel, etc.

Ivax Pharmaceuticals Analytical Research & Development 2000-2003

Senior Research FellowDeveloped, validated, and transferred methods of analysis (Assay, Impurities/Degradant, Dissolution, Biodissolution) for drug substances and finished drug products.Developed dissolution methods for XR/ER/MR formulation

using USP App. III, Bio-disSupervised analytical method developments and validation procedures. Evaluated newly formulated drug products in terms of content uniformity, in-vitro dissolution characteristics, etc., and provided support for product development. Supervised chemists performing tests on drug substances and drug products. Reviewed documentations and ensured compliance with CGMP and SOP.

REMIGIUS A. NNODIMELE, Ph.D.

Physical/Chemical characterization and qualification of drug substances for use as In-House reference standards.Prepared and reviewed validation documentation for FDA, ANDA submissions, following CDER guidelines.Conducted Polymorphic evaluation of drug substances and products by X-ray powder diffraction (XPD), Differential Scanning Calorimetry (DSC) and FTIR, FTNIR.

Ivax Pharmaceuticals Analytical Research & Development: 1994-2000

Research FellowDeveloped, validated, and transferred methods of analysis (Assay, Impurities/Degradant, Dissolution, Biodissolution) for drug substances and finished drug products.

CHEMISTRY DEPT., BAYLOR UNIVERSITY: 1991-1994

Postdoctoral Research Fellow Designed and conducted research in the area of electrochemical oxidation of solids in micellar media and explored the use of such oxidations for synthetic organic, analytical and environmental applications.Designed ‘Thin Layer Cells’ for the study of Electrochemical oxidation of solids.Supervised undergraduate research students.

EDUCATION

Baylor University Waco, Texas. 1985-1991

Doctor of Philosophy Chemistry (Analytical/Physical)

University of Jos, Jos, Nigeria 1978-1982

Bachelor of Science Applied Chemistry

AFFILIATIONS

American Chemical Society.

PUBLICATIONS

List available upon request.

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