Engineer Engineering

Henny Hampton

nd st

Primary Address ● ***-** ** Avenue 1 FL ● Bayside, NY 11361 917-***-****

Secondary Address ● 717 S Columbus #PH13 ● Philadelphia, PA 19147 ************@*****.***

Profile:

M.S. Chemical Engineer with 5 years pharmaceutical experience. In depth knowledge and expertise in

drug product stability, CMC section of regulatory submissions (NDA and MAA applications) and

biopolymer and nanomaterial R&D.

Summary of Experience:

CMC Stability Studies: Design & Execution Nanomaterial R&D: Synthesis

of Stability Protocols and Stability Reports. (mesoporous silicas: MCM-41, SBA-15;

Regression analysis of analytical stability silica aerogels). Characterization (XRD,

results. Investigation and root cause analysis TEM, BET)

of deviations including out of specification

Supervisory Experience: Manage

(OOS) results and out of trend (OOT) results.

responsibilities of Stability Technicians and

Expert in Excel and Designed Macro

Temporary employees to hit team deadlines.

programming for process automation.

Developed CMC Team functional process.

Biopolymer R&D: Processing (extrusion,

Software: Professional (LIMS, POMS,

casting, thermoforming). Characterization of

eDocs, SAS, Trackwise). Simulation and

biopolymer films (tensile tests, TGA, DSC,

process design (Aspen, Hysys, Matlab).

SEM). Rheology of biopolymer solutions.

Expert in Excel (Macro creation).

Professional Experience:

Forest Laboratories 2007 – Present

Scientist III, CMC (Chemistry, Manufacturing and Controls)

Commack, NY

Key accomplishments

Served as a critical member of several CMC-Stability teams resulting in the successful FDA approval

of two drug products.

Primary Responsibilities

Manage the stability program of 4 products in varying stages of NDA submission and approval

Supervise Stability Technicians and Temporary Associates

Ensure the timely CMC release of all batches for use in clinical studies

Detailed Responsibilities

Stability:

NDA Stability: Design NDA stability protocols / Analyze & trend stability data / Perform

regression analysis to project shelf life / Author NDA stability report

Drug Product Stability (New drug products and Lifecycle for approved drug products): Design

stability protocols to support current clinical studies/ Monitor resulting stability data / Create

reports to support IND submissions & Annual reports

Management: Instruct technicians to perform sample labeling, stability setup & pull activities /

Coordinate stability data compilation through stability technicians / Train temporary associates

in the stability module of LIMS & related SOPs. Involved in all internal and partner audits.

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Henny Hampton

nd st

Primary Address ● 200-19 32 Avenue 1 FL ● Bayside, NY 11361 917-***-****

Secondary Address ● 717 S Columbus #PH13 ● Philadelphia, PA 19147 ************@*****.***

Packaging Materials: Provide Clinical Packaging with recommendations for alternative

packaging materials to avoid non-conformance results and to improve overall stability

Clinical Trial Materials (CTM)

CMC review: Global review of raw materials and manufacturing documentation to perform

the CMC release of all batches that will be used for clinical studies / Evaluation of release

analytical data to establish batch variability and manufacturing issues.

Regulatory Submissions

NDA: Author NDA stability report and CMC stability section. Member of the CMC team that

addresses FDA responses

IND (Investigational NDA): Review IND and Annual reports stability sections

Canadian and European submissions: Review stability section and provide expiration date

assessments.

Research Experience:

Biotechnology Institute of Colombia (IBUN) 2005 – 2007

Research Scientist

Bogota, Colombia

Member of an interdisciplinary team which focus on the industrial applications of a proprietary glucose

biopolymer

Key accomplishments

Developed biopolymer films with suitable mechanical, thermal and transmission properties for

pharmaceutical/biomedical applications.

Primary Responsibilities

Produce biopolymer films via extrusion.

Evaluate the mechanical, thermal and transmission properties of the extruded biopolymer films.

Detailed Responsibilities

Researched a method for the manufacture of viable biopolymer films

Investigated variables affecting extrusion processability of a glucose biopolymer

Characterized the rheological behavior of biopolymer-additive solutions

Evaluated the mechanical (tensile testing, texture analysis), thermal (DSC, TGA), transmission

and thermosealing properties of biopolymer films.

The University of Oklahoma 2003 – 2004

Senior Research

Nanotube Research Group – Prof. Daniel E. Resasco

Synthesized mesoporous silicas: MCM-41, Co/MCM-41, Co-MCM-41 and SBA-15 and evaluate

the influence of the synthesis conditions and surfactant on the pore diameter

Studied material properties using X-ray Diffraction (XRD), Transmission Electron Microscopy

(TEM), physical adsorption of nitrogen (BET), and Ultraviolet and Visible analysis (UV-vis)

Presented Research at the University of Central Oklahoma for state research day: Incorporation

of transition metals on MCM-41 for catalytic support purposes

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Henny Hampton

nd st

Primary Address ● 200-19 32 Avenue 1 FL ● Bayside, NY 11361 917-***-****

Secondary Address ● 717 S Columbus #PH13 ● Philadelphia, PA 19147 ************@*****.***

Catalysis Research Center (CICAT) 2002-2003

Research Engineer

Bucaramanga, Colombia

Synthesized silica Aerogels and studied the effect of processing conditions on the morphological

and physical properties of the resulting materials.

Characterized the morphological (SEM, TEM), surface (BET), physical and optical properties of

silica Aerogels.

Education:

2007

M.S. Chemical Engineering

Universidad Nacional de Colombia

Bogota, Colombia

Areas of specialization: Bioengineering and Polymer Engineering

Chemical Engineering Simulation: Aspen, Hysys, Matlab

Thesis: Study of the variables that affect the extrusion processability of a glucose biopolymer

2004

B.S. Chemical Engineering – Exchange Program

University of Oklahoma

Norman, OK

President’s Honor Roll – Distinction for students with an overall GPA of 4.0

Senior Research: Synthesis and characterization of MCM-41, Co/MCM-41 and SBA-15

2003

B.S. Chemical Engineering

Universidad Industrial de Santander

Bucaramanga, Colombia

Areas of specialization: Material Engineering and Simulation

Thesis: Synthesis and Characterization of Silica Aerogels – Outstanding Thesis award winner -

Computer Software:

Laboratory Information Management System (LIMS), Management of Manufacturing Operations

(POMS), Document Management System (eDocs), Statistical Analysis Software (SAS),

Trackwise, Crystal Reports

Conceptual Design, performance improvement of Chemical Process (Aspen, Hysys)

Programming Languages (Matlab, C++)

Microsoft Office (PowerPoint, Word, Excel expert)

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