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T O P I C     R E V I E W
davidallen David Allen, D.Chem.
5320 SW 30th Way
Dania Beach, FL 33312
(954) 614 3864 (cell)
[email protected]

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Qualifications

- Experienced in:

HPLC LIMS PAT

NIR IR UV-Vis

SFC GC XRF

Chemical Imaging Chemometrics Fluorescence

Analytical Solid phase Computer programming
automation extraction

Particle Traditional Dissolution
Characterization wet chemistry (USP Apparatus II & IV)

- Experienced in providing analytical and automation support for Drug Discovery, Synthetic, MAP, Formulations, and QC chemists.

- Experienced in methods and technology development for Production, Drug Discovery, Formulation, and QC labs.

- Expert in instrument interfacing and programming.

- Experienced in cGMP / FDA work environments.

- Creative problem solver with strong analytical abilities and a high degree of mechanical, computer, and chemical expertise.

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Achievements: Analytical and methods development

* Developed HPLC methods for QC and Drug Discovery groups using a range of columns and detection techniques including diode array, R.I., variable wavelength, ELSD and pre and post-column derivatization for fluorescence detection.

* Developed analytical methods for raw materials, solid dose products, new formulations and suspensions including NIR, Dissolution (USP apparatus II and IV), Particle Size, Assay and Content Uniformity testing.

* Performed method and equipment validation in QC/ cGMP / FDA environments.

* Investigated and resolved problems in production and QC environments using traditional techniques plus MS, XRF and chemical imaging technologies.

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Achievements: Automation

* Implemented sample prep routines on common automation platforms such as Zymark, Tecan, Gilson, Packard and Cavro.

* Developed automation systems using Tecan, Zymark and Nimbl equipment to perform synthesis for chemical library generation.

* Integrated instruments (such as Agilent and Waters HPLC) to automation and data systems to improve lab efficiency.

* Connected automation systems to the internet for remote access and control

* Supported in-house programs written by other developers

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Achievements: Management

* Supervised group of 5 permanent and 2 temporary employees involved in new implementations of laboratory automation and LIMS

* Coordinated movement of development laboratory from CA to OK, including method transfer and equipment re-validation.

* Analyzed and reported on data for Intellectual Property transfer and FDA filing

* Wrote policies, procedures and software to manage and control clinical trial samples stored in -20 deg. C freezers.

* Established, reviewed and revised SOP and STM for QC, Drug Discovery and Clinical Analysis groups.

* Participated in new hire process for staffing of QC and development laboratories.

* Provided automation, analytical, instrumentation, technical and computer support for QC, drug discovery, formulations, analytical and production chemists

* Managed projects involving multiple departments and external vendors to meet deadlines and ensure successful completion.

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Achievements: Technology development

* Invented and implemented new technologies for semi-prep chromatography, producing dried fractions in less than 1 hour.

* Invented new liquid detection system to validate robotic liquid transfers.

* Developed containerized chemistry concept to improve resin handling for solid phase chemistry through automatic tracking of reactions and minimizing reagent use. This included designing and building an automated reaction processor to manipulate reagents and wash solutions.

* Implemented RF chip based inventory control system to track reagents and intermediate compounds

* Designed and built a number of systems to aid chemists and improve lab efficiency. Including automated resin-processing systems for solid phase chemistry, new extraction and fast isolation techniques.

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Work Experience

- Andrx Pharmaceuticals (FL) 2004
Supervisor, Automation and Robotics Group

- Tunnell Consulting (PA) 2003
Consultant - Analytical Chemistry

- Yamanouchi Pharma. Tech. (OK) 2002
Scientist - Methods Development Laboratory

- Coelacanth Corp. (NJ) 2000
Lead Systems Integration Engineer

- Vertex Pharmaceuticals Inc. (MA) 1996
Automation Systems Integrator

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Education

Doctor of Chemistry University of Texas at Dallas
(Synthesis and characterization of MRI contrast agents /
Methods development for characterizing oil sands)

M.S. - Chemistry University of Texas at Dallas
(Developed fabrication technique for cyclic voltammetry electrodes)

B.S. - Chem. / Comp. Sci. Tarleton State University
(Cum Laude)

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Training

- Information Mapping, 2005

- Prescription for Leadership workshop, 2005

- IVT seminars on NIR Applications in PAT. 2005

- National Seminars course on Project Planning, 2004

- Skillpath seminars on budgeting and management, 2002

- "Managing The Modern Analytical Lab" ALMA conf. 2002

- Zymark AIS certification training

- Beginning and Advanced Multi-Probe Programming (Packard Liquid Handler)

- Novell network administrator

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