Shikheldin Bilal Mohamed
Pharmaceutical Research And Development
Antioch,TN
Summary
» Profile - Extensively trained in the fields of problem-solving, strategic planning, decision-making, leadership, mediation, negotiation, facilitation and team building with exceptional communication and interpersonal skills. - Committed to staying current on innovation in pharmaceuticals, R&D and biological sciences. Detail-oriented and thorough; dedicated to providing excellence in organizational and personal assignments. Adept at managing multiple, diverse tasks simultaneously; work well under pressure. Confident professional communicator with outstanding listening and presentation skills. Goal-oriented and self-motivated, focused and hardworking who can quickly grasp system operations and get the job done. Analytical self-starter with a strong attention to detail and the ability to bring order to chaos. Highly creative with more than 14 years of career and volunteer experience. - Track record of gaining greater efficiencies from existing resources. Able to use strong technical background to analyze complex processes and develop innovative solutions to challenges.
Overview
10
10
years of professional experience
14
14
years of post-secondary education
Work History
Chemist Pharmacist
Petnet Solutions – A Siemens Company
Nashville, TN
11.2011 - 07.2013
- To perform general laboratory functions including materials management, radiation safety monitoring and measuring, production assistance in accordance with regulatory standards and internal policies and cleaning the facility
- Responsibilities and Duties:
- Performed end-to-end production of radiopharmaceuticals in accordance with applicable cGMPs and NDA requirements which includes materials management, product documentation, quality control, radiation safety monitoring, and production in accordance with regulatory standards and internal policies and procedures
- Performed production activities to produce and prepare 18F-labeled compounds in strict compliance to written procedures
- Performed complex quality control analyses in strict compliance to written procedures including:
- Used computer-controlled radiosynthesis modules and quality control equipment
- Used, maintained, and completed documentation in compliance with quality procedures and regulatory requirements
- Maintained the laboratory and its equipment, including but not limited to preventative maintenance on QC and chemistry equipment per SOP
- Maintained a clean, clutter free facility and well organized production area and workflow
- Performed complex manufacturing (cyclotron and chemistry module operation) and quality control processes, under supervision when required by State and Federal law
- Participated in complex inspections, maintenance and troubleshooting, including root cause analysis to support manufacturing and testing processes and equipment
- Interfaced with corporate functions for purposes of training, technical support, process changes, data management, reporting, and quality
- Identified opportunities for improving efficiency in the production process
- Provide exemplary customer support
- Performed other tasks as assigned by supervisor
- Basis computer skills such as, Excel, Word and Outlook file creation and manipulation.
Senior Research Scientist
Berg Pharma
Nashville, TN
06.2010 - 06.2012
- Performed assay testing and developed test methods, impurity, and stability to support formulation scientists and meet project deadlines
- Assisted in EHS program to improve regulatory compliance and staff safety
- Supported program in maintaining instruments and completing routine calibration
- Performed sampling, analyses, and documentation in accordance with SOP’s, protocols, reports and procedures
- Performed troubleshooting of Agilent HPLC systems
- Maintain analytical equipment, including HPLC, UV/VIS, Karl Fisher titrator, pH meter, Conductivity meter, sonicator and centrifuge
- Coordinated installation and qualification of customized HPLC system to be used for successful development of topical cream product
- Authored method validation protocols and reports, stability reports, deviation reports, and change controls
- Assisted in lab maintenance; lab safety, and waste disposal, ensuring proper standards are met
- Trained new and old staff on lab’s instruments and EHS for compliance with company procedures
- Developed test methods for pre-formulation by HPLC
- Optimized an impurity method to reduce Analysis time and reducing solvent usage
- Maintained appropriate documentation (records and lab notebooks) as required by SOP’s that complies with all GLP/cGMP regulation
- Assisted in manufacturing of sterile formulations and aseptic techniques to test and develop intravenous and topical products
- Prepared product formulation procedure and manufacture prototype batches
- Operated microfluidizers, automated vial fillers and crimpers, and homogenizers
- Performed particle size analysis on Malvern Zetasizer analyzer, pH meter, conductivity meter, and osmometer
- Consolidated and organized supplies/equipment, and implement lean inventory management to conserve space and costs
- Performed crimped vials leakage test, package integrity test and pH, particle size, gravity test, viscosity analysis on intravenous stability samples
- Trained in the use of Distek dissolution
- Drafted forms for performance monitoring of stability chambers
- Replace monitor charts on stability chambers on routine basis
- Performed labeling of stability samples
- Write SOP’s for instruments calibration and operation to improve site compliance as assigned
- Performed routine lab maintenance and cleaning of process equipment as necessary
- Maintained raw material COA files.
Lab Technician/Lab Teaching Assistant
Vanderbilt University
Nashville, TN
01.2010 - 05.2010
- Provided laboratory technical services for students, lecturers, and faculty of specialized undergraduate instructional labs
- Prepared reagents and solutions for various undergraduate and analytical instructional laboratories
- Provided technical support and served as assistant in preparing experiments
- Purchased required materials, received shipments and verified contents, assembled, tested and installed new equipment
- Maintained, controlled and stored a sufficient inventory of supplies and equipment
- Prepared, set up and issued materials and equipment for use in student laboratory demonstrations, experiments, exercises and exams
- Assisted in the operation and maintenance of instructional labs
- Participated in the planning and implementation of lab exercises and experiments
- Implemented new or modified policies and procedures as required
- Prepared special instructions for non-routine and complex assignments
- Constructed, adapted, tested and maintained equipment and apparatus used in the chemistry laboratory
- Responsible for setting up instrument-computer interfaces
- Trained lab staff and students in the safe and proper use of laboratory equipment and hazardous materials
- Prepared, tested, adjusted, modified, and performed routine maintenance on and calibrated a variety of laboratory equipment
- Performed troubleshooting of equipment and made minor repairs or arranged for vendor service
- Publications “The Synthesis and Characterization of Gd2 (MoO4)3 Nanostructures Using the Microemulsion Synthetic Technique” M.S
- Preparation and Characterization of Hydroxyapatite (Ca10(PO4)6(OH)2) Nanopowders using Sol–Gel Technique for Biomedical and Pharmaceutical Applications” Ph.D
Research Assistant
Temple University
Philadelphia, PA
05.2003 - 11.2004
- Managed daily operations of laboratory
- Planned laboratory methods and procedures
- Assisted in modifying methods and procedures on as-needed basis
- Day-to-day physical maintenance of the laboratory techniques: western blot techniques, Serial dilution methods, Gel and Buffer preparation, labeling chemical after testing using various methods, performing assays, and Cell Culture.
Education
Ph.D. - Biological Sciences
Tennessee State University,
3500 John A. Merritt Blvd Nashville TN 05.2017 - 05.2022
Master of Science – MS - Chemistry – Nanotechnology Organometallics Materials
Tennessee State University, John A. Merritt Blvd
01.2005 - 08.2009
Bachelor of Science – BS - Chemistry Honors – Biochemistry - Cancer Research
Tennessee State University, John A. Merritt Blvd
01.2005 - 08.2009
Certificate of Completion, Osiris TEM/STEM Training - undefined
Certificate of Completion, FT-IR, Malvern Zetasizer, Quartz Crystal Microbalance (QCM) Training - undefined
Vanderbilt University
Certificate of Completion, Operations II Training for Pharmacy Employees Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, Operations I Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, radiation Protection Training for Nuclear Pharmacy Employees Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, D.O.T./Hazardous Materials Training Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, Introduction to Current Good Manufacturing Practice Concepts - undefined
Petnet Pharmaceuticals
Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Beyond the Foundation Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Beyond the Foundation FAQ’s and Reference Material Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Deliver Reliability Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Quantitative Accuracy Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Imaging - undefined
Pharmaceuticals
Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion - undefined
Amyloid: Total Solution Introduction Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, Radiation Principles, Biological Effects of Radiation and Radiation Risk Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, Operations II Training for HPLC Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Timeline
Ph.D. - Biological Sciences
Tennessee State University,
05.2017 - 05.2022
Chemist Pharmacist
Petnet Solutions – A Siemens Company
11.2011 - 07.2013
Senior Research Scientist
Berg Pharma
06.2010 - 06.2012
Lab Technician/Lab Teaching Assistant
Vanderbilt University
01.2010 - 05.2010
Master of Science – MS - Chemistry – Nanotechnology Organometallics Materials
Tennessee State University, John A. Merritt Blvd
01.2005 - 08.2009
Bachelor of Science – BS - Chemistry Honors – Biochemistry - Cancer Research
Tennessee State University, John A. Merritt Blvd
01.2005 - 08.2009
Research Assistant
Temple University
05.2003 - 11.2004
Certificate of Completion, Osiris TEM/STEM Training - undefined
Certificate of Completion, FT-IR, Malvern Zetasizer, Quartz Crystal Microbalance (QCM) Training - undefined
Vanderbilt University
Certificate of Completion, Operations II Training for Pharmacy Employees Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, Operations I Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, radiation Protection Training for Nuclear Pharmacy Employees Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, D.O.T./Hazardous Materials Training Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, Introduction to Current Good Manufacturing Practice Concepts - undefined
Petnet Pharmaceuticals
Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Beyond the Foundation Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Beyond the Foundation FAQ’s and Reference Material Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Deliver Reliability Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Quantitative Accuracy Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, MI – Amyloid: Imaging - undefined
Pharmaceuticals
Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion - undefined
Amyloid: Total Solution Introduction Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, Radiation Principles, Biological Effects of Radiation and Radiation Risk Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
Certificate of Completion, Operations II Training for HPLC Petnet Pharmaceuticals, Inc - Siemens - undefined
Vanderbilt University
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