Research scientist, chemist, manager, cordinator

HESHAM A. SHERIF

*** ****** ***, ****** ** ****6

Cell: 510-***-****

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

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OBJECTIVE

To lead development and manufacturing of oligonucleotide at a pharmaceutical company

HIGHLIGHTS OF QUALIFICATIONS

• Strong leadership and problem-solving abilities, team player, excellent communication and technical writing skills.

• Broad spectrum of experience in oligonucleotide chemistry, nucleic acid chemistry, analytical development, stability studies, formulation development, SOPs, process validation protocols, project management and pharmaceutical manufacturing.

• Proven proficiency in working with drug developers, 3rd party contract manufacturers, both domestic and international, as well as, managing inter-company alliances for drug substance manufacturing of Phase I - Phase III material.

• Manage the manufacturing team and its overall workload to insure product orders are delivered on time and work meets specifications, quality standards, timelines and budgets.

• Set up oligonucleotide synthesis labs from hiring personnel and selecting equipment to jump-starting production and on-site personnel training.

• Hands-on experience in current DNA, RNA and LNA synthetic technologies. Skilled in solid phase synthesis of phosphodiesters, phosphorothioate branched and modified oligonucleotides.

• Skilled in purification using various chromatography techniques such as Reverse phase, Ion exchange, and PAGE methods.

• Experienced in the on-line and post-synthetic conjugation of oligonucleotides with dyes and proteins.

• Skilled in characterization, using spectral analysis (UV/Visible spectroscopy), RP-HPLC, IEX-HPLC, and SEC-HPLC, NMR, CE and Mass spectrometry.

PROFESSIONAL EXPERIENCE

Principal Scientist: Dynavax Technologies, Berkeley, CA (January 2008-Date)

• Evaluate and select manufacturing contractors and suppliers.

• Manage and oversee contract manufacturing organizations (CMOs) of non-GMP and cGPM oligonucleotides.

• Develop new oligonucleotides for preclinical and clinical studies.

• Prepare and review Chemistry Manufacturing and Controls (CMC) technical reports and CMC section(s) of regulatory submissions from Phase 1 through Registration

• Play a key role guiding cross-functional teams, internal and external collaborations; provides expert opinion regarding development of new oligonucleotides to internal teams.

• Take an active role in development and discovery projects, serving as a mentor and resource to team members.

• Responsible for the GMP manufacturing of the oligonucleotide, which is the Immunostimulatory Sequence (ISS) for HEPLISAV™; that is a Phase 3 investigational adult hepatitis B vaccine.

• Leading the development of branched oligonucleotide conjugate for a novel candidate drug for asthma.

• Core team member of developing a vaccine intended for treatment of chronic hepatitis B infection.

• Managing the CMC activities on developing novel TLR inhibitors for diseases such as lupus and rheumatoid arthritis.

• Chemical Safety Office, providing resources and support for reducing potential chemical and environmental hazards.

Senior Research Associate: ThermoFisher Scientific-Milwaukee, WI (January 2002-January 2008)

• Managed and preformed the oligonucleotide production. Implemented time and cost efficient strategies which lowered the cost of the oligonucleotide manufacturing.

• Reviewed, modified and created Standard Operating Procedures (SOP)s for custom and standard oligonucleotides production.

• Developed new methods for purification of oligonucleotides and specialty amidites.

• Coordinated order fulfillment activities across department functions as QC/QA and materials management.

• Evaluated and resolved customers complaints for Amidites and Oligonucleotides products.

Chemist: Pierce Milwaukee, WI (September 2000-December 2001)

• Design and work out synthetic routes of DNA and RNA Phosphordiamidite.

• Purification of nucleic acid compounds and oligonucleotide.

• Scale up organic compounds and key intermediates.

• Transfer technologies to manufacture groups.

Teaching Assistant, Graduate Research Assistant: Chemistry Department, Marquette University. Milwaukee, WI (June 1999-December 2004)

• Taught General Chemistry and Organic chemistry courses.

• Developed a new four step route for the synthesis of oligosilanes pendant p-cyanostalbene chromophore. Synthesized a pentasilane precursor for use in the new route for pentasilanylsyanostilbene to investigate the photophysical properties and photoreactivity of intramolecular charge transfer excited states of oligsilanylarenes.

• Synthesized and studied of Keto Oxime esters as a photochemical "cage" compounds for photorelease of biomolecules, which are useful for photosensitized degradation of polystyrene, photoimaging systems and photoresists for printed circuit boards, and holography.

Technical Expert: Egyptian Fund for Technical Cooperation with Namibia. (January 1992- May 1997)

• Planned and organized the assessment systems concerning technical and administrative aspects of teaching chemistry.

• Developed procedures and curriculum for the International General Certificate of Secondary Education (IGCSE) in Namibia.

Clinical Laboratory Technologist: Ministry of Health, Mansoura, Egypt (June 1986--December 1991)

• Performed complex chemical, biological, hematological, immunologic, and microscopic tests.

• Evaluated test results, developed and modified procedures, and established and monitored programs, to ensure the accuracy of tests.

TRAINING COURSES

• WCE. Lean Manufacturing 5S, June 2005.

• The principles of Leadership, August 2005.

• Project management, The Lewis Institute, December 2005.

• Internal Auditing for ISO 9000 Systems. November 2006.

• Essential facilitation, Interaction Associates. September 2009.

• Scientific Presentations. On-Site English. October 2009.

EDUCATION

Marquette University, Milwaukee, WI, USA

M.Sc. 2004. Organic Chemistry.

Mansoura University, Mansoura, Egypt

Post-Graduate Diploma of Science. 1991. Applied Chemistry.

Mansoura University, Mansoura, Egypt

B.Sc. 1985 Major: Chemistry.

References will be provided upon request

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