Gary Dean Email & Phone Number

Greater Pittsburgh Region

ResponsibilitiesDevelop and implement the external manufacturing strategy aligned with company goals.Lead cross-functional teams to manage external manufacturing projects.Collaborate with supply chain teams to optimize production and logistics for global distribution.Identify risks in external manufacturing and develop mitigation strategies.Key SkillsStrong knowledge of biopharmaceutical manufacturing processes and regulatory requirements.Proven ability to lead teams and manage external partnerships effectively.Strong verbal and written communication skills for collaboration and negotiation.Problem-Solving: Effective at identifying challenges and implementing solutions.Experienced working in diverse, global environments.

Canonsburg, Pennsylvania, United States

Note: Viatris is a new company created through the merger of Mylan and UpjohnThis role ensures global launches in established and emerging markets are executed according to timelines agreed upon with key stakeholders. This is accomplished through cross functional working teams (manufacturing, supply chain, logistics, regulatory, legal and quality) from the manufacturing site (internal & external) and the commercial markets where the product will be distributed. Operations Services is a component within Viatris' global manufacturing organization. These products are produced at Viatris' internal manufacturing sites as well as CMOs/3P organizations and marketed in both established and emerging markets around the world. Presently this role is focused on biosimilar and respiratory products.

Canonsburg, Pa

This role ensures product launches in established markets are executed according to timelines agreed upon with key stakeholders. This is accomplished through cross functional working teams (manufacturing, supply chain, logistics, regulatory, legal and quality) from the manufacturing site (internal & external) and the commercial markets where the product will be distributed. Operations Services is a component within Mylan’s global manufacturing organization. These products are produced at Mylan internal manufacturing sites as well as CMOs/3P organizations and marketed in both established and emerging markets around the world. Presently this role is focused on biosimilar and respiratory products.

Greater Pittsburgh Area

Engineering Center of Excellence- Services/Responsibilities:--Development of Global Engineering Standards for Facility Construction, Utilities and Equipment--Identification of best practices and communication of these to the organization--Leadership/support for projects designated as being strategically critical to the organization--Guidance for aseptic processing and facility design and improvements--Risk management input related to regulatory questions/concernsGlobal Engineering Technologies- Responsibilities--Support key strategic initiatives to include: --Start-up of a new/renovated facilities (US & Asia)--Technical support/troubleshooting of key new product launches--Due diligence activities--Technical review/support for new facility/process design and construction for sites in the US, EU, India and Asia--Provide engineering support to Mylan’s manufacturing facilities across the globe, with aseptic manufacturing as a core focus.

Bedford, Oh

Develops vision and sets overall direction for team of pharmaceutical professionals responsible for specification, installation start-up, commissioning and decommissioning of aseptic processing equipment (fill/finish), critical utilities and capital improvement/expansion projects. Responsible for identification and execution of regulatory compliance (FDA & EU) initiatives, related to facility and process engineering improvements.Key Accomplishments- As a member of Boehringer Ingelheim's (BI) Global Engineering Network (GEN) expert team on clean rooms, co-authored BI's "HVAC System Design Guideline" global guidance document. This guideline was approved by all global business unit heads in 2012 and adopted as an international corporate guideline.- Identified gap and coached cross-functional team through development of operational strategy and implementation of SOP(s) necessary to manage lifecycle of critical change parts used in aseptic manufacturing, thereby reducing potential risk elements and incorporating a structured approach to management of these critical parts. This risk management process was shared with BI corporate engineering as a ‘best practice’-Led cross-functional global team responsible for performing gap analysis of current BVL HEPA filter management practices as compared to BI and industry best practices. Utilizing a risk based approach, a guideline for HEPA filter management, from procurement/specification through installation, routine recertification and decommissioning, was drafted.

Managed process and facility engineering team, which provides operational support (equipment & critical utilities) for daily manufacturing, executes capital project from design through commissioning.Key accomplishments-Led Process Engineering team supporting facility renovations, totaling >$100M across several projects. Cumulatively these efforts resulted in the installation, commissioning and validation of vial filling machines, raised stopper detection systems, autoclaves, washer/tunnels, depyrogenation ovens, vial sealers, nitrogen distribution systems, temperature control units and HVAC upgrades. The equipment was a mix of new and refurbished equipment.-Responsible for execution of static airflow visualization studies, required as a result of refurbishing Grade A/Class 100 filling suites.-Engineering lead for regulatory audits related to systems/equipment under my team's responsibility.

Manage team of Process Engineers responsible for all engineering aspects of fill/finish equipment, within a contract, aseptic manufacturing organization for pharmaceuticals, to include vial washers, depyrogenation tunnels, autoclaves, lyophilizers, syringe/vial fillers, and high speed, automated inspection, labeling and packaging (ILP) systems. Responsible for new equipment specification, procurement, installation, start-up and execution of validation protocols (IQ & OQ) for manufacturing systems. Process Engineering team provided all automation engineering support for the site.

Managed Process Engineering and Lyophilization Technology DepartmentsOver 200 hours of training in Lean manufacturing and Six Sigma/blackbelt

Started as a maintenance technician supporting automated (computer and PLC controlled) manufacturing systems. Progressed to the role of a systems engineer, developing new systems and upgrading existing systems.

The USAF not only taught me how to service, repair and maintain a variety of aerospace ground support equipment (diesel, gas turbine and electric powerplants, hydraulic test stands, HVAC, pneumatic generators, AC/DC power generation, etc) I also learned fundamentals of leadership, discipline, teamwork and the ability to maintain focus on core mission objectives under less than ideal circumstances.I enjoyed my time in the military and am grateful for the many things that I was taught and learned over the years. Changes in my ambitions and goals prompted me to look towards the civilian sector for employment, even though it meant losing the little bit of seniority that I had established and the safety of a guaranteed job/paycheck for the next 20-30 years. I have never regretted the time that I spent in the AF, nor the decision to leave; timing is everything in life.