Joel Nichols

Founded and operated a consulting firm for digital and IT strategy; managing resourcing needs through other consultants and employees in my firm. Cell & Gene Therapy CDMO: - Built the IT strategy and application roadmap - Established IT governance and PMO processes - Delivered the data strategy to build the data lake Medical Apparel company: - Defined data strategy - Built application consolidation strategy

Delivering novel gene editing through the use of AI/ML in a fully automated, cutting edge laboratory environment all while working with some of the brightest minds in the world. I am leading the digital systems organization comprised of software engineering, lab automation, lab informatics, data engineering and information technology.

Leading integrated IT and data management strategy which impacts all of our client’s programs and growth initiatives. Internally, I am responsible for Primecore IT operations, data management and security.

Working with this innovative life sciences software solutions company, I am assisting in growing the business in the U.S and Europe while driving the solution to further solve the key problems that leaders in supply chain and quality face within the industry.

- Led as part of the corporate leadership team, reporting to the president - Defined and executed R&D product & data strategy and product roadmap - Led AOP planning and prioritization to support roadmap and growing market needs - Responsible for development and management of software product portfolio globally - Responsible for delivering SaaS (software-as-a-service) customer data platforms - Designed divisional organizational structure and plan for 5 years to match strategy - Defined and executed IT security strategy to drive ISO27001 compliance and presented the results to the Board - Responsible for initiating a zero-based budget with $1M operational efficiencies - Delivered rapid tech transformation coloration and business apps in Cloud within 6 months to support remote work improving 70% of efficiencies

- Led a team of PDP for software product development and commercialization - Led hiring and onboarding of global teams of medical device software engineers to develop solutions that fully integrated clinical trial processes, captured clinical data for analytics - Created and led the Innovation Community of Practice to harvest and implement disruptive ideas for customer success - Acted as a liaison with sales, quality, marketing and product management to commercialize medical device software per ISO 13485 regulations - Led the evaluation and selection of vendors and tools to support business strategy

- Created a corporate IT strategy with an integrated digital strategy revolving around data, security, people, and foundational IT - Evaluated ERP solutions and implemented SAP S4/HANA with a strategic implementation partner - Defined and executed cloud-first strategy for all key business systems including manufacturing - Responsible for resource planning and hiring global teams to develop and manage software product portfolio - Established Cybersecurity council to review and roll out security controls adhering to NIST standards - Sponsored and responsible for setting up IT PMO and governance to process alignment and delivery visibility - Accountable for vendor management and vendor performance for all of the key product portfolio

- Built an organization of over 100 people in three continents - Developed the vision and business for the future of digital bioprocessing for Life Science - Established a GAMP compliant agile executable software development plan - Transformed R&D automation group into a scaled agile software development organization - Managed a $300 million 8 year budget - Developed marketing and sales strategy for bioprocessing connected systems - Led negotiations for long-term SCADA partnership

- Responsible for IT strategy and execution of greenfield start-up manufacturing site - Manage group of managers leading infrastructure, MES, QA/QC systems, business intelligence, ERP, and computer systems validation activities. - Manage capital and expense budget for project. - Coordinate project management reporting activities through site and corporate project management offices. - Champion efforts on process improvements and compliance initiatives for the site; leveraging technology to achieve site business objectives.

- Lead and manage the Manufacturing Execution Team (MES) - Hire and establish project strategy and plan to implement MES across 5 lines at the manufacturing plant. - Managed scope, resources, and timeline for greenfield manufacturing site of fractionation of plasma and multi-product batch manufacturing.

- Provided IT and automation strategy for the site to enable integration of systems - Managed IT & automation teams for recently acquired manufacturing facility - Established IT vision to enable business analytics - Led a team to convert manual processes into automated platforms - Acted as a liaison between IT and engineering and business units to collaborate and deliver solutions to support the business - Led a team of 20 to deliver high quality hardware and software solutions - Re-organized process automation to align with corporate support goals - Created business proposals and presented to senior leadership to procure funding for IT and process automation projects

- Managed IT due-diligence processes for Elanco merger and acquisition activities - Negotiated IT services and activities with partnering companies by creating a transition services agreement (TSA) - Managed IT activities in TSA throughout the negotiated timeline - Coordinated intra-company supply-chain and financial meetings internationally for ERP integration of newly acquired products - Managed small team of M&A IT consultants through ERP and CRM integration - Facilitated IT integration, including cutover of network and global IT services, for a newly acquired international manufacturing plant