Joshua M. Bader
Strategic Thinker Goal Focused Trend Analyst
Highly skilled technical professional and chemical engineer in the pharmaceutical industry. Skilled in assessing process safety related issues and bringing new products and processes such as New Drug Abbreviation (NDA) into a manufacturing facility. Adept in qualifying equipment and ensuring optimal operation through trial and test for best results. Instrumental in streamlining and improving processes, enhancing productivity, and implementing technology solutions. Recognized for leadership skills in a manufacturing environment. Areas of Expertise
• Process/Product Development • Mechanical Aptitude • Presenting
• AKTS • Analysis & Research • Process Engineering
• Calorimetry • Process Design • Thermal Characterization
• Design of Experiments • Heat Transfer • Quantitative Measures PROFESSIONAL HISTORY
MERCK & CO. INC., on Assignment from ExecuPharm, Rahway, NJ June 2017 – Present Process Safety Engineer
Evaluated environmental and process safety hazards to construct Environmental and Process Safety Reports to provide recommendation for safe and compliant scale up from the lab to supply processing. Provided technical support for thermal and pressure hazard testing equipment to ensure continuous operation. Key Accomplishments:
• Manage chemical process safety related issues including thermal hazards, industrial hygiene and environmental risks during the process transfer.
• Testing and report recommendations include: thermal and pressure hazards, heat of reaction, material of construction, industrial hygiene, waste stream characterization, environmental hazards, use of highly toxic and/or hazardous materials, and dust Explosivity.
• Collaborated with Project Leaders on 3+ Active Pharmaceutical Ingredients (APIs) to deliver process safety reports to the pilot plant and supply sites.
• Responsible for maintenance and calibration of sensitive thermal and pressure characterization equipment.
• Adept and identifying and alleviating issues that arise from continual use of sensitive lab equipment.
• Developed expertise in calorimetric equipment including: DSC, TGA, Z3, MMC, ARC, ARSST, corrosion studies, Drop Weight, Dust Testing, and waste stream characterization equipment (pH, Conductivity).
• Focus on using new technologies to proactively identify risks and provide mitigation strategy.
• Involved in preliminary assessment of flow chemistry in the safety lab.
• Lead research and testing to bring new equipment to the lab which provided more reliable test results.
• Independently found erroneous results in past thermal characterization reports and remediated errors with self-designed experiments and newly purchased equipment.
• Independently researched and verified the capabilities of new thermodynamic software against lab experiments to determine the accuracy of calculated data.
• Continually developing strong presentation skills.
• Created a poster which was presented at the Merck World Wide Meeting.
• Safely work with hazardous chemicals.
• Took initiative to update SOG’s to align with current testing standards. SUN PHARMACEUTICALS, Cranbury, NJ Feb 2016 – June 2017 Associate Engineer
Responsible for optimizing performance and streamlining processes during new equipment installations. Point person and lead for identifying trends through research and analysis of data points. Adept in the design and implementation of pharmaceutical processes to increase productivity and decrease manufacturing costs. Key Accomplishments:
• Collaboration on a major corporate project for the New Drug Administration filing (NDA) and playing an instrumental role in gaining FDA approval that will drive pharmaceutical sales and marketing.
• Worked closely with interdisciplinary teams regarding the requirements for usage of new equipment to the facility and produce user requirement specification (URS) documentation.
• Increased manufacturing quality by writing and implementing the process qualification (PQ).
• Authored Standard Operating Procedure (SOP), Batch Manufacturing Records (BMR) and manufacturing protocols for new equipment and manufacturing procedures.
• Reduced the back-logged reports and studies documentation through diligence and a focused, organized approach to resolving this issue.
• Spearheaded the installation of manufacturing equipment for the new generation of liquid filled products enabling increased market share, quality manufacturing and increased revenues.
• Ensured safety and equipment quality for the new NDA process by analyzing the equipment specifications and operational qualifications and filing the NDA filing PQ forms.
• Instrumental in quality assurance during the manufacturing of liquid filled capsules.
• Collaborate on quality improvements for trans-dermal functions.
• Generated improvements in the ERP system and manual forms, allowing for better organization of integrated applications which enhanced use and automation of back office functions related to technology, services and HR.
Bachelor of Science, Chemical Engineering New Jersey Institute of Technology, Newark, NJ, 2015. GPA 3.94 RESEARCH & PUBLICATIONS
NJIT, Summer Nanotechnology Undergraduate Research Program, Summer 2015
• Selected as one of six students with funding provided by the National Science Foundation (NSF).
• Designed an experiment in which it is hypothesized that antimicrobial cationic peptides can facilitate the antibiotic-loaded Nanoparticles to penetrate the biofilm of MRSA and enhance cellular uptake of drug to more efficiently destroy MRSA bacteria. Abstract published by NJIT in 2015 Book of Abstracts. o Presented to the 2015 NJIT 8th International Undergraduate Summer Research Symposium. Co-author of the chapter: “Green Nanomaterials Preparation: Sustainable Methods and Approaches” in Green Photo-Active Nanomaterials: Sustainable Energy and Environmental Remediation. Published November 2015, by the Royal Society of Chemistry.
ADDITIONAL RELEVANT WORK EXPERIENCE
Journeyman Plumber / Journeyman, NJ 2006 - 2014
Initiated plumbing career as an apprentice in 2006 and expedited the process to Journeyman, working through four companies and applying effective skills in of all phases of residential, commercial and industrial plumbing and service. Trained new employees and led the installation and repair of plumbing issues. Key Accomplishments:
• Excelled in application of fluid flow trouble shooting, control systems and electromechanical devices for the identification of problem sources and the repair or recommendation of solution options to the customer.
• Supervised new plumbing apprentices, mentored and coached professional development in areas such as plumbing techniques, skill building and customer service.
• Met the customer and legal requirements as an integral part of the team during construction of a co- generation plant at the harbor in New York City.
• Increased customer loyalty and retention by providing exemplary quality of work and service.