Mohamed Mazine Sadik Email & Phone Number

Chapel Hill, Nc, Us

•Support the CAPEX group in engineering needs and facilitate project execution for client and CAPEX projects•Oversee technical and commercial aspects of projects, reporting directly to Manager of CAPEX Project Mgt.•Provide input to streamline engineering processes and assist in project approvals

Cary, North Carolina, United States

United States

• Process MSAT Lead for new Commercial Manufacturing Facility for biologics (monoclonal antibodies)• Subject matter expert in large scale downstream unit operations (including purification equipment, column packing, chromatography operations, dead end filtration, viral filtration, TFF (tangential flow filtration), and Bulk Fill)• Author and execute fundamental SOPs and prepare Technical Documents for new facility processes such as characterization and mixing studies• Provide project leadership as a lead or technical resource, and design and draft process flow diagrams (PFDs) and single use assemblies for downstream processing• Develop User Requirement Specification (URS) documents for equipment • Perform and support commissioning and qualification (FAT/SAT and IOQ) activities for downstream equipment (mixers, chromatography systems, and UF/DF systems) • Develop and review mass transfer balances and piping and instrumentation diagrams (P&ID)• Support technology and process transfer to and from the Manufacturing facility to ensure developing processes align with established large-scale and/or Commercial Manufacturing technology practices

Raleigh-Durham-Chapel Hill Area

• Support Biogen Engineering group during Large Scale Manufacturing tech upgrade start-up• Work closely with Biogen Engineers (Process, Validation, and Quality Engineers) and suppliers to identify and mitigate issues regarding P&IDs, PFDs, and equipment • Perform review of Engineering Turnover documentations (P&IDs, PFDs, and equipment) for Biogen Biologics Large Scale Manufacturing upgrade• Develop conceptual design documents such as PFDs, material balances, URS, and process models

Gainseville, Florida

Core Team Member: Managing and leading Operations activities relevant to human nerve allograft Biologics License Application (BLA) submission•Assist in the strategic deployment of the extended engineering team supporting BLA, leading operations engineering projects portfolio, prioritization of BLA projects, and alignment of BLA projects goals to the Company goals•Provide leadership, consulting and troubleshooting on technical problems that arise in product and process development of various Biologics product•Conduct process research and process development to develop a CMC and cGMP compliant process and facility to meet BLA requirements •Collaborate with Core Team members from R&D, Quality, Regulatory and Clinicians to develop and execute stability study to demonstrate product, and process stability •Prepare and execute test method validations for process final inspection (Visual and dimensional)•Designed and developed a quantitative method for measuring nerve graft dimensions (Patent Pending) to significantly improve process flow and product quality by reducing product sizing discrepancies•Contribute to establishing an improved Process Validation system, with the help of Regulatory/Quality VP and Operations VP, to meet CMC requirements and cGMP standards for Biologics •Lead a team of three engineers (manufacturing/processing/R&D) in the systematic analysis of current manufacturing process to improve process flow, identify cost saving opportunities, and most importantly, develop a scale up model and layout of a new manufacturing facility that will meet CMC and cGMP requirements for BLA •Assist R&D engineering team in designing and developing a bioreactor for soaking, and incubating product in various solutions.•Managing a cross-functional team to design, develop, and qualify a new package for a nerve Graft allograft product. The new package will reduce cost of product storage by 5 million dollars.

Santa Ana, Ca

Project 1: Developing a statistical model to improve selection of the optimal porcine-derived heart valve stent attachment size for the Mosaic and Hancock II Tissue Heart Valves sizing processes. The implementation of this model is projected to save the company $1.2 million/year by decreasing downstream discards due to size discrepancies. •Work independently and as part of a team managing the heart valve sizing project between the Research and Development, Quality Engineering, Manufacturing Engineering, and Production Operations Divisions •Conduct feasibility study by collecting experimental data in an ISO Class 8 Cleanroom to characterize physical dimensions for Mosaic and Hancock II products •Develop and optimize a statistical model and set criteria for determining the correct heart valve size in order to remove sources of variations within fresh tissue sizing Project 2: Implemented three machining processes of Mosaic and Hancock II bare stents from Polyetheretherketone (PEEK) material using Mori Seiki Turning Center.•Directed the planning and execution of software (G-Codes) and process validation to qualify the machining of PEEK bare stents in a new NLX1500MC/500 CNC Turning•Designed and developed tooling for manufacturing stacked stents from PEEK•Increased production capacity by threefold per day while conserving raw material, and minimizing machining time of bare stents via nesting and stacking machining processes •Performed statistical analysis using Minitab to qualify the machining processes•Ensured compliance with Quality Manual ISO 13485 and FDA GMP in terms of the Design History File, Parts & Materials, and Test Protocols•Organized and led meetings with a multidisciplinary team comprised of members from the Research and Development, Quality Engineering, Regulatory affairs, and Manufacturing Engineering Divisions•Generated reports, protocols, and process validation documentation (IQ/PC/OQ/PQ)

Greater Philadelphia Area

Project Overview: Designed and developed devices for rapid separation, concentration, and detection of pathogens in food matrices•Designed and built a filtration system used for the extraction and detection of Salmonella nucleic acids in liquids•Developed a model for nucleic acid amplification on a microfluidic device•Directed a scientific team in the design and fabrication of a cell phone-based system for on-site isolation and detection of nucleic acids•Coordinated and supervised cross-disciplinary projects between the School of Engineering and Applied Science and the School of Veterinary Medicine providing detailed data, results, analysis and summary reports to both parties•Acted as a liaison between Penn and the USDA, disseminating results and communicating future planned studies •Utilized MatLab and COMSOL to solve the autocatalytic amplification reaction of HIV RNA in a microfluidic channel•Mentored and designed experiments for four undergraduate students and three graduate students

Piscataway, Nj

Project#1: Investigated the electrodeformation of giant unilamellar vesicles using optical diagnostics•Designed and fabricated devices to synthesize vesicles by the electroformation method•Developed a synchronized system comprised of an electrical circuit that delivers square pulses and optical diagnostic tools to visualize electrodeformation of vesicles•Systematically characterized a new regime of large electrodeformation with high conductivity ratio and high electric field•Assisted to develop the first comprehensive model to quantitatively predict large vesicle electrodeformationProject #2: Designed and implemented experiments to investigate the complex transport mechanisms and to quantify the molecular uptake in electroporation-mediated molecular delivery•Conducted a temporally and spatially resolved study of molecular uptake via fluorescence microscopy as a function of the extracellular buffer electrical conductivity •Designed, fabricated, and calibrated an electroporation system comprised of electrical circuits, an electroporation chamber, and a synchronization interface with a fluorescence diagnostics system•Quantified molecular delivery by performing in-depth analysis of data; identified different transport regimes via direct comparison with modeling resultsProject #3: Quantification of macromolecular delivery efficiency and viability using flow cytometry•Conducted a parametric study of a combination of high voltage and low voltage double pulse experiments to optimize delivery efficiency and viability during electroporation •Performed flow cytometry and fluorescence microscopy to quantify molecular uptake and viability •Pioneered optimized electroporation pulsing protocols based on theoretical understanding and extensive data analysis to improve molecular delivery via electroporation•Participated in the implementation of the optimized protocols in a microfluidic platform

Piscatway, Nj

Teaching Assistant, Department of Mechanical and Aerospace Engineering Mechanical Engineering Measurements Lab(14:440:350)- Managed 4 sections with 18 students in each section (72 students in total)- Implemented a new teaching scheme for the course to enhance the students learning experience- Troubleshot and fixed problems with lab setups to ensure consistency of results

Villejuif, France

Project Overview: Initiated and pursued an international collaborative project to investigate the permeabilization and transfection of cellular spheroids using confocal microscopy; the project was sponsored by an IGERT Fellowship•Utilized a synchronized electroporation system with confocal microscopy to visualize the permeabilization of spheroids and DNA electrotransfer into spheroids in real time•Cultivated cellular spheroids of Human Mesenchymal Stem Cells, and B16 Melanoma Cells utilizing hanging drop and low adherence methods•Improved the permeability and transfection efficiency of spheroids by 20% with optimized electric field pulsing schemes

Doctor Of Philosophy (Ph.D.), Mechanical And Aerospace Engineering, 3.84/4.0

Activities and Societies: NSF IGERT Fellow, Mechanical Engineering Fellow, Teaching Assistant, Tau Beta Pi Chapter Advisor, tutoring, MEGA.

Bachelor Of Science, Mechanical And Aerospace Engineering, 3.86

Activities and Societies: Secretary of ASME (American Society of Mechanical Engineering) Rutgers Chapter, President of New Jersey Beta Tau.