Katie Chaddock
Site Head of Commercial Manufacturing @ Orca Bio
About
I’m interested in collaborating and sharing expertise with the community by offering informal networking advice, guidance, and contacts across all facets of manufacturing operations & supply chain leadership, business development & planning, KPI & program oversight, and LEAN continuous improvements. Ways that I contribute my expertise: ➨ Building strategic growth plans for industry-leading organizations, rendering immediate decisions to impact company success, and maximizing profitability by streamlining processes, leading supply chain efficiencies, and delivering customer solutions ➨ Implementing continuous operational improvements, spearheading complex new organizational programs, crafting multi-year roadmaps to expand global markets, exceeding client expectations, and enhancing cost quality & delivery of goods ➨ Fostering capacity spikes with competitive analysis & LEAN tools, structuring fundraising & communication plans, meeting aggressive deadlines for external partners & government agencies, and creating compelling presentations ➨ Saving significant capital while increasing manufacturing volume & spending, negotiating contracts with manufacturers & third-party vendors, incurring upticks in delivery times, and aligning site closures with delivery schedules ➨ Expertly aligning projects with staff strengths, motivating teams to attain unprecedented results by communicating complex challenges into easy-to-understand solutions, and constantly seeking areas for improvement for long-term organizational growth It's always helpful to interact with other open-minded professionals both in and outside personal areas of industry expertise. Please reach out via LinkedIn or at katiechaddock@yahoo.com should you also see a benefit in professional networking and exchange.
United States
Napa
Pharmaceuticals
Non-Governmental Organization (NGO) Support , Direction of Mission & Vision, Mentoring, Training, Team Leadership, Budgeting, Forecasting, Cost Reduction, Cross-functional Communication, LEAN Continuous Improvements, Risk Management, Business Development, Competitive Analysis, Program Launch, Program Development, Customer-Centric Solutions, Vaccine Distribution, Global Volunteering, Organizational Design, KPI Design & Launch
Experience

Head of Autologous Platform Competitiveness
New Jersey, United States
With this promotion I have been extended oversight of continuous operational improvements and an opportunity to support the autologous CAR-T cell therapy network. I oversee our network budget, leveraging this resource in crafting multi-year roadmaps and strategic plans for global market expansion, enhanced patient care, and overall operational excellence. In just a few months I have already made significant impacts including driving $70 million in spending reductions; developing plans to eliminate 40% of the cost of goods delivering +20% profit; and changes allowing% growth in capacity in the next five years. If you’d like to know more about what I do and how I do it feel free to reach out for a conversation. I’m always happy to talk shop. I report to the VP of autologous therapies.

Head Vaccines Manufacturing, Partnerships & External Supply
New Jersey, United States
In report to the VP of partnerships and external supply, my energies were focused on oversight of 22 global staff in startup and commercial operations of a vaccines external manufacturing network. We responded as quickly as possible to the global pandemic by delivering a billion COVID vaccines to the commercial market in less than two years. ➲ Managed the start up of a $1.4B network delivering over $10 B in revenue ➲ Meaningfully improved communications between Janssen and the CMOs, and ➲ Streamlined batch release processes utilizing real-time data analytics.

Executive Leadership Team Facilitator
I thoroughly enjoyed this rare chance to steer a team of 12 executive supply chain vice presidents in executing strategic supply chain initiatives. In direct report to the president of Janssen Supply Chain, I optimized monthly senior executive vice president meetings supporting the global supply chain. From creating agenda points and moderating real-time discussion and decision-making, I maintained unity between the group which led to more productive meetings and valuable outputs.

General Manager, Plant Operations
Vacaville, CA
For six years I reported to the VP of small molecule operations and oversaw +500 employees in daily functions of a pharmaceutical manufacturing facility. Annually. I allocated a healthy operating budget, supervised P&L, and drafted and implemented strategic site plans. My most memorable contributions consist of the time I saved $20 million while still boosting manufacturing volume 35% by utilizing LEAN manufacturing principles and generating a +50% uptick in delivery times including alignment of site closure with delivery schedules and leading employee transition programs.

Director Global Quality Assurance
Novato, CA
My ambition to improve customer education was realized after I initiated cross-functional partnering and collaborations with the European Medicines Agency (EMA). Together, we upgraded packaging and leaflets for multi-country small-volume orphan drug launches. Getting information to those who need it is a huge priority of mine and I was glad that I was able to get the right people on my team to make this happen! If you’re interested in learning more about these projects, let’s talk.

Senior Director, Manufacturing Operations
Morgantown, West Virginia, United States
My priorities were focused on guiding 25 managers in overseeing up to 800 unionized production staff for a 17-billion-unit manufacturing operation. Safety, quality, and reliable delivery were integral elements in budget decisions. I was proud to deliver notable outcomes including – ➲ $2 million in overtime reductions ➲ A 10% increase in operational efficiency ➲ Significant labor relations improvements A variety of strategies was leveraged in delivering these highlights including enacting staff engagement programs, implementing LEAN Six Sigma process improvements, adopting Kaizen and 5S principles, forming and communicating clear roles and responsibilities, and negotiating optimal union terms and conditions. I reported to the VP and general manager of operations.

Senior Director of Operations
Napa, California, United States
As the Sr. Dr. of Operations for Mylan Specialty (Dey Pharma), I did not take for granted my impact in leading 200 staff in producing FDA regulated inhalation solutions, nasal spray, and eye drops. My accountabilities and influence spanned operations, packaging, engineering, maintenance, technical services, and new product launches. I learned a lot as I oversaw a $10.6 million clean room suite expansion and the installation of $50 million in new equipment. Ultimately, this was an incredibly fulfilling position, and I was even more motivated to produce when I rescued $2.2 million in revenue by steering critical investigations to improve product quality and found a way to reduce the cost of goods by 15%.

Director, Quality Assurance
Morgantown, West Virginia, United States
Here I led seven staff in validating computerized system lifecycles, instrumentation, equipment, and sites. We coordinated efforts to drive GMP and regulatory-approved program improvements; support compliance inspections for the FDA, EMA, DEA, and Irish Medicines Board; and oversee construction of a 500,000-square-foot oral solid dosage (OSD) site expansion. Our efforts were not for naught, seeing as we – ➲ Saved +6,000 labor hours ➲ Attained a coveted Irish Medicines Board manufacturing certification after leading a pivotal risk assessment across multiple functions.

Project Lead Enterprise Asset Management (EAM)
Morgantown, West Virginia, United States
In this role, I facilitated critical programs and projects to improve Enterprise Asset Management (EAM) systems. I managed a diverse group of resources and teams consisting of consultants and company personnel to implement SAP’s plant maintenance and spare parts inventory management functionality. ➲ Improved 12% of asset efficiency by leading teams in SAP implementation

Process Operations Engineer, Engineering and Maintenance
This early role garnered me valuable experience in coaching project engineers in facility, equipment, and production initiatives. Together we designed business cases, reports, and cost justifications for site and operation improvement programs. Additionally, I managed budgets for capital facility projects and steered 10% improvement in plant utility system uptime, I reported to the engineering and maintenance senior director.
Katie Chaddock's Contact Information
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