Quality Assurance Medical
Resume:
Nahed M. Mohsen
Curriculum Vitae
Plymouth, Michigan 48170, USA
Tel: 734-***-****
Email: cf5tnn@r.postjobfree.com
Education
Ph.D. Bioengineering, University of Michigan, Ann Arbor, Michigan, USA (1995)
Area of concentration: biomaterials science: materials’ biocompatibility, polymer based composites
Physics, chemistry, aging and durability, polymer-powder/cross linking agents interactions & interfacial
characterization
M.S. Bioengineering, University of Michigan, Ann Arbor, Michigan, USA (1989)
Areas of qualifications: transport phenomena (fluid, mass, and heat), blood coagulation and
cardiophysiology
M.S.E Industrial & Systems Engineering, University of Michigan, Dearborn, Michigan, USA (1989)
Area of concentration: statistics, experimental design & quality control
B.A. Psychology, University of Michigan, Dearborn, Michigan, USA (1985)
B.S. Biochemistry, University of Michigan, Dearborn, Michigan, USA (1984)
Professional Experience
Nooryn Group (4/2012 – present)
Polymer Composite Consulting Firm
Founder & Partner
Plymouth, Michigan, USA
Consult and advise clients in product development, technology transfers, process manufacturing, material structure properties, statistics and wet coating.
Exponent (Failure Analysis Associates) (11/2007 – 3/2012)
Managing Engineer/Manager
Biomedical Engineering Practice
Farmington Hills, Michigan, USA
Lead manager for corporate-client teams in technology transfer, regulatory, quality assurance, scientific, and engineering arenas including the following the following:
Management & Leadership:
• Project management and administration including planning and proposals, budgets and resources, execution and timeliness, delivery and compliance.
• Developed and maintained necessary team/individual training programs as required by local, state, federal, corporate and project/client requirements.
• Developed and implemented safety programs in compliance with governmental regulations (OSHA) and corporate policies.
• Led investigations, root-cause analysis and implementing CAPA according to clients’ quality management system and corporate policies.
• Presented and frequently interacted with corporate executive leadership and management teams and provided progress updates and reports
• Negotiated contracts, agreements and T&Cs with executive leaderships and legal counsel.
Research and Development:
• Worked with surfactants and silicones for coating of materials and powders.
• Developed product /material/powder coating including wet and spary.
• Developed and designed performance testing programs for polymer based ocular shunts, catheters, cardiovascular implants, implantable meshes, collagen and gelatin implants and devices and dental implants.
• Developed and designed testing programs for product material/coating /structural/ manufacturing failures by devising CAPA analysis.
• Assessed and evaluated polymers’ chemistry and physics related issues including discolorations, sticking, aging, and short and long durability for medical products that are made of silicones, acrylates, urethanes, nylons and polypropylenes.
• Developed testing programs for polymer chemical resistance, physical and chemical aging, durability and thermal stability.
• Assisted companies on coating medical devices, implantable meshes and polymeric materials to achieve certain physical and chemical properties.
• Worked on several atomization methodologies to achieve certain coating features and certain droplets/particle size distribution in the nano and micro ranges.
• Assisted companies on adhesive failures on medical products.
• Assisted companies in their medical products that are made of collagen and gelatin as they relate to cross-linking determination, characterization, biocompatibility, stability, and long and short terms durability.
• Assisted companies in drug formulations’ particle design, coating technologies and powder nanotechnologies to achieve high efficiency, appropriate dissolution, pharmacokinetic profiles and targeted drug delivery for different drug product dosage forms.
Regulatory Affairs and Quality Assurance:
• Developed regulatory strategies and directed interaction with the US Food and Drug Administration (FDA) for medical devices and pharmaceutics products registrations.
• Audited, developed and implemented quality assurance systems including ISO 13485, ISO 17025, FDA QSR 21 CFR 820, cGMP, 21 CFR 210 and 211, and ICH Q7, Q8, Q 9 and Q 10.
• Audited and developed systems for FDA 21 CFR Part 803 Medical Device Reporting, FDA 21 CFR Part 806 Corrections and Removals.
• Audited and developed companies’ systems including; quality, management, risk management, CAPA, complaints handling and adverse events reporting.
• Developed quality system procedures and regulatory submissions related to Chemistry, Manufacturing and Controls (CMC) sections for NDAs, 505b2s and ANDAs and submission for IDE, 510K, DMF’s and color additive petitions for medical devices and drugs.
• Implemented quality systems according to GLP, cGMP and ICH guidance.
• Assisted companies in obtaining regulatory approval for their medical devices such as ocular shunts and devices containing antimicrobial agents such as triclosan and devising testing strategies for color petitions in ocular drug product combination.
• Audited, developed and implemented design control, verification/validation testing, CAPA, quality by design, product recalls, risk analysis and management, and FMEA analysis.
• Devised verification and validation testing programs and protocols for several medical devices to support 510K and PMAs submissions.
I3 StatProbe, United Health Group (11/2006 – 10/2007)
Scientific Communication Specialist
Ann Arbor, Michigan, USA
Medical information and scientific communication including
• Developed and wrote aerosol drug products clinical trials protocols for Phase I and Phase II.
• Developed and wrote peer-reviewed articles in the areas of women and men health.
• Responded to medical/scientific/technical information requests from external customer groups including healthcare professionals.
• Reported/audited adverse event for client’s medical devices in MED Watch.
• Produced and disseminated medical information enquiry metrics and analysis for assigned product portfolio.
• Developed and maintained scientific expertise and familiarity with literature regarding assigned products portfolio, including competitor products.
• Audited clinical trials CRF’s.
Independent Consultant (1/2004 – 10/2006)
Consulted, served and assisted clients in pharmaceutical and medical devices products development and technology transfer including:
• Evaluated technologies, conducted bench marking, assessed technologies for patentability and licensing potentials.
• Worked on techniques and methods to develop droplets that are applicable for coating and printing techniques.
• Developed and managed drug products programs including development (regulatory, clinical and technical), marketing and commercialization.
• Lead the efforts in technology transfers from bench to manufacturing.
• Involved in products management at different stages in the development.
• Audited, developed and implemented quality systems regulations and requirements.
• Prepared documentation for regulatory submissions including NDAs, 505b2s, ANDAs, IDEs, 510Ks.
• Developed and provided testing programs and strategies to answer FDA’s questions, inquiries and deficiencies in submissions.
• Provided expertise to regulatory and product development teams for regulatory requirements, quality assurance and marketing.
• Audited companies’ systems including; quality, management, risk management, CAPA and complaints handling and adverse events reporting.
Sheffield Pharmaceuticals, Inc. (9/1998 – 12/2003)
Principal Scientist/Group Leader
Ann Arbor, Michigan, USA
Headed the Ann Arbor R & D division involving oversight of all the scientific, technical, operation and resources including staff, equipment and supplies, managed and provided directions and training of scientists and engineers, and worked in several areas of drug product development including the following:
Business Development, Marketing & Regulatory Affairs
• Assessed product opportunities, conducted initial market surveys, identified differentiable new therapies, performed benchmarking studies, developed regulatory strategies, established budgets and resources, and interacted with external regulatory and marketing consultants, intellectual property and patent lawyers.
• Evaluated technologies, for patentability and licensing potentials, oversaw patents filing and managed patent applications.
• Created marketing, product developments, licensing and programs funding strategies for products.
• Involved in negotiations, drafts, terms and conditions for technology agreements and licensing deals.
• Developed and managed drug products programs including development (regulatory, clinical and technical), marketing and commercialization.
• Lead the efforts and managed technical, methods and manufacturing technologies transfer.
• Developed regulatory strategies and action plans to gain market approval for 9 drug combination products in the USA & Europe, prepared CMC sections to support INDs, NDAs, 505b2s and ANDAs submissions, provided responses to regulatory queries, solved CMC related-issues, summarized pre-clinical & clinical studies, managed document and represented the company before the FDA.
• Implemented cGMP documentation requirements in the laboratories.
Project Management
• Managed multiple projects including developing and tracking projects (time, resources and budget), intellectual properties, and publications using computer based project management software and tools.
• Worked with multiple partners and multi-disciplinary groups.
• Wrote summaries, technical reports, presentations and recommendations.
Clinical Research
• Developed exploratory and Phase I clinical trials studies, including study design, protocols’ write up, CRFs’ design, sites monitoring, studies’ initiations, preparing/packaging clinical trials supplies, and training clinical personnel on testing, handling and administering the drug products during clinical trials.
• Analyzed deposition, pharmacodynamic and pharmacokinetic data collected from Phase 0, I and II clinical trials and summarized results.
• Monitored and managed CRAs/CROs.
Research, Development and Manufacturing
• Invented techniques and methods to develop droplets that are applicable for coating, printing and aerosolization techniques.
• Invented, designed and managed the development of 5 novel aerosol drug delivery systems (one pMDI, two DPIs and two nebulizers) to deliver respiratory and systemic formulations through the pulmonary route from proof-of-concept to different stages of clinical development including mechanical, functional, and ergonomic designs, as well as industrialization and packaging of the delivery systems.
• Managed the efforts of particles/powder design using different powder technology techniques (e.g., Super Critical Fluids (SCF), Spray Drying, Precipitation) to control powder size, morphologies and shapes to produce crystalline, amorphous, micro and nano-crystal particles, and developed studies, protocols, specifications and ICH stability programs for reformulated powder.
• Invented, developed and produced bio-batches for 9 different aerosol formulations (liquid and suspension) including 2 steroidal anti-asthma, 2 anti-migraine, 4 non-steroidal asthma drugs, and one pain formulation.
• Developed and validated methods, product specifications, protocols and procedures to evaluate drug product performance and implemented testing programs for CMC and stability according to FDA/ICH/GMP guidelines.
• Designed, coordinated, and conducted process development activities for manufacturing of different drug formulations for clinical supplies at various CMOs and managed all resources, SOPs, batch cards, supplies and bio-batches scale-ups.
• Negotiated contracts and deals with contract manufacturing sites and contract labs.
• Identified and managed sites for preclinical testing programs including toxicology studies and analytical testing.
Laboratory & Analytical
• Started, built and managed the corporate analytical laboratories including equipment and quality systems.
• Developed, validated and maintained testing methods’ protocols, SOPs and documentation procedures, and implemented the infrastructure for cGMP.
• Established and lead the efforts of maintaining records of inventories for raw materials, laboratory supplies, drug supplies, equipment and their calibration, preventative maintenance and operational procedures.
• Lead the effort of establishing safety and environmental procedures.
• Identified, sourced and procured APIs and suppliers for manufacturing of clinical and commercial drug liquid, suspension, sterile, non-sterile and aerosol drug products.
Lawrence Technological University (8/1999 – 5/2000)
Adjunct Professor
Department of Natural Science, Southfield, Michigan, USA
Taught undergraduate chemistry courses.
Aeroquip Corporation (3/1996 – 8/1998)
Associate Research Engineer
Corporate Technology Organization, Ann Arbor, Michigan, USA
Started The Aerosol Drug Delivery Corporate Venture and accomplished the following:
Business Development
• Performed strategic planning, market analysis, competition and product opportunities assessment, and developed business plans for novel aerosol drug delivery system business.
• Evaluated technologies, conducted bench marking, assessed technologies for patentability and licensing potentials, oversaw patents filing and managed patent applications.
• Created marketing, product developments, licensing and programs funding strategies for products.
• Involved in negotiations, drafts, terms and conditions for technology agreements and licensing deals.
• Developed and managed drug products programs including development (regulatory, clinical and technical), marketing and commercialization.
• Involved and managed technical, methods and manufacturing technology transfers.
• Identified the functional arms of the business including consultants, personnel, CROs, and testing labs.
• Presented Aeroquip’s new aerosol drug delivery technology to potential buyers and venture capitalists.
Research & Development
• Invented aerosol drug delivery concepts, designs and models and established proof-of-concept using imaging and aerosol measurement techniques.
• Developed correlation criteria between optimum atomization conditions and optimum inhalation delivery using CFD simulations and experiments.
The University of Michigan (1/1990 – 5/1995)
Graduate Research Assistant
Joint appointment with the Department of Material & Biological Sciences, School of Dentistry, Department of Material Science & Engineering and the Department of Bioengineering, Ann Arbor, Michigan, USA
Researched several topics including:
• Developed physical and chemical methods in achieving urethane polymer systems that require certain physical and chemical properties and features.
• Evaluated biocompatibility and cytotoxicity of biomaterial polymer-based composites.
• Identified chemicals leached from polymer-based composite.
• Developed methods for coating of inorganic phases (powder) in polymer-based composites and evaluating their stability, property-structure relationships, and their impact on the physical properties of these composites.
• Characterized the interface & evaluating polymer-powder interaction w/wo coupling agents in these composites using unique techniques.
• Examined effects of the environment on these interactions.
• Examined effects of different additives on molecular mobility of polymers in polymer-based composites.
• Examined continual chemical and physical aging of polymers using spectroscopical & thermodynamic approaches.
The University of Michigan (1/1987 – 5/1988)
Research Assistant
The Extracorporeal Membrane Oxygenation (ECMO) Laboratory, Department of Surgery, Medical School, Ann Arbor, Michigan, USA
Conducted several tasks including:
• Collected samples & perform data analysis from in vivo experiments in dogs and sheep, including blood
& urine samples.
• Improved the thermal regulation of ECMO system.
Therapeutic and Medical Device Experience
Cardiovascular, pulmonary/respiratory (asthma and COPD), diabetes, CNS (pain management & migraines), women’s health (osteoporosis and breast cancer), medical devices (nebulizers, insulin and pain pumps, ocular shunts, catheters, vascular stents, cardiovascular implants, implantable meshes, collagen and gelatin implants and devices and dental implants)and drug delivery systems (aerosol, pulmonary, nasal, ocular, transdermal and parenteral).
Laboratory & Computer Skills
• Molecular & Conformational Characterization of Macromolecules: Dielectric Measurements Methods
Analytical Methods: UV/Vis., HPLC, FT-IR, Karl Fischer coulometry
• Enthalpy Measurements Methods: Microcalorimetry, Dynamic Mechanical Testing (Torsion Pendulum) & DSC
• Mechanical Strength Tests: Tensile, 3-Point Bending, Modulus & Knoop Hardness
• Aerosol Measurement: laser diffraction particle analyzer, Cascade Impactors, & Dose Unit Sampling Apparatus (DUSA)
• Surface Measurements: Contact Angle
• In vitro Cell Culture Testing
• MS Office: Word, Excel, Powerpoint & Project, Sigma Plot and RefMan; UNIX operating system
Professional Affiliations & Awards
• American Association of Pharmaceutical Scientists (AAPS), 1999–present
Chair of Pharmaceutical Packaging Development Focus Group, 2009–present
• Food and Drug Law Institute (FDLI), 2007–present
Medical Devices and Diagnostics Committee member, 2011
• Regulatory Affairs Professional Society (RAPS), 2007–present
• Drug Information Association (DIA), 2007–present
• International Society For Aerosol in Medicine (ISAM), 2007–2010
• American Chemical Society (ACS), 2009–2010
• American Association of Dental Research (AADR), 1991–1998
• Material Research Society (MRS), 1993–1997
• Engineering in Biology and Medicine (EBM), 1992–1997
• Institute of Electrical and Electronic Engineers (IEEE), 1992–1997
• “Strategic Management of Innovation and Technology” Certificate of Achievement from Aeroquip Corporation on 12/19/1997
Continued Educational Courses
Advances in Proteins and Gene Therapy (11/14/1999)
The Annual meeting and Exposition of the American Association of Pharmaceutical Scientists, Ernest N. Morial Convention Center, New Orleans, LA, USA
Advances in Controlled Release Technology: Polymeric Delivery Systems for Pharmaceuticals, Proteins and Other Agents (6/17/1996 – 6/21/1996)
Massachusetts Institute of Technology, Cambridge, MA, USA
Good Manufacturing Practice GMP/GLP (12/10/1996)
Aeroquip Corporate Technology Organization, Ann Arbor, MI, USA
Summary of Patents, ROIs, & Publications
13 Patents granted including: EP 0911048A2 and WO 9920331A1,
18 Records of Inventions (Aeroquip Corp., and Sheffield Pharmaceuticals, Inc.),
7 Publications,
1 Webinar,
12 Presentations and Published Abstracts of Presentations, and
13 Published Abstracts and Posters.
Complete listing is provided upon request.
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