Josh Nelson

Experience

• 

  Tissue Genesis, Inc.

  May 2008 - Mar 2012

  Biologist
• 

  Tissue Genesis, Inc.

  May 2012 - Dec 2015

  • Responsible for product management including order processing, inventory management, device shipment. Built an inventory management database• Supervised work of 3 employees, directed both laboratory and engineering activities. • Acted as interim director of product development for over 1 year.• Drafts experimental plan based on given hypothesis, execute plans and conduct data analysis• Lead role in designing start of the art tissue isolation system• Help prepare grants and Small Business Innovation Research, with multiple successfully accepted and awarded funding• Help prepare reports to support various grants including DoD• Coordinate weekly laboratory work in a GLP/ISO 13485 facility• Work with NASA on in-flight and space effects on human cells pertaining to vascular system• Coordinate research and development of an automated cell separating system• Present updates to management monthly• Interact with contract manufacturers and suppliers on a regular basis• Responsible for identifying new equipment, as well as installation of new equipment. Responsible for equipment maintenance, calibration, troubleshooting. • Design prototypes utilizing computer aided design software, as well and assist in building working prototypes utilizing various machinery • Coordinates shipping and tracking of automated perfusion cell and tissue culture systems. Show less

  • Acting Product Development Manager/ Project Manager

    Apr 2008 - Dec 2015

  • Project Manager

    May 2012 - Dec 2014
• 

  TruTag Technologies, Inc.

  Feb 2015 - Jul 2018

  Senior Manufacturing Technician

  • Lead technician in the manufacture of porous silica utilizing wet chemistry and semi-conductor technologies• Collect data from research projects and enter into appropriate databases, analyze, prepare reports and presentations.• Help develop key process as well as design new methods resulting in increased throughput and cost savings. Identify new technologies and equipment to help improve process throughput and drive cost down • Receive, install, calibrate, maintain, and operation of new equipment• Lead role in identifying maintenance procedures and maintenance schedules for both current and new equipment, as well as writing operating procedures and SOPs• Play a key role in designing and improving custom equipment, including breakthrough technologies in the semiconductor and wafer processing industry. Responsible for testing, troubleshooting, and identifying areas of improvement • Play a key role in training of current and new employees on manufacturing process and equipment use• Trained in hazardous waste/chemical handling and neutralization, full face respirator certified. Played a key role in transition from research facility to FDA registered, GMP compliant production, including writing of multiple SOPs and policies. Show less

• 

  Catalent Pharma Solutions

  Jul 2018 - Jun 2024

  • Manages the technology transfer process (both Internal and External) into Manufacturing • Act as Subject Matter Expert (SME) on Biomanufacturing activities and oversees the implementation of operational process improvements and process excellence in collaboration with internal and external stakeholders, ensuring respective requirements are met and integrated in the Manufacturing process. • Actively manages resolution of deviations, out of specifications and CAPA’s, including via cross-functional teams. • Leads and develops others’ training in process and compliance-related procedures to ensure Regulatory requirements and company policies are met. • Authors, edits, and reviews SOPs, Production Records, Job Aids and associated documents. • Supports the validation and execution of process equipment to meet timelines and regulatory requirements. • Actively leads team meetings and/or training sessions. • Performs daily review of executed cGMP documentation (BPRs, forms). • Coordinates with Manufacturing Leadership to prioritize and schedule activities to meet established deadlines. • Performs aseptic techniques within a clean room environment. • Executes and properly documents cGMP Biomanufacturing activities. • Operates and troubleshoots cGMP Biomanufacturing equipment such as pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). • Accurately completes routine and preventive maintenance on Biomanufacturing equipment. Routinely drafts and revises Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aids (JA) • Leads deviation investigations and change control/protocol execution within established timelines. • Evaluates operational efficiencies and work flow schedules effectively meeting client demand. • Reviews validation protocols and change controls. Show less

  • Senior technical project lead, manufacturing optimization

    Jan 2021 - Jun 2024

  • Lead, Biomanufacturing

    Jul 2018 - Jan 2021
• 

  Sterling Pharma Solutions

  Jun 2024 - now

  Commercial Technical Manager