Gregory Stec Email & Phone Number

Project manager leading the successful execution of source change projects for the transfer of pharmaceutical formulation and packaging processes to new internal and external supply chains. Responsible to define scope, project schedules, resources, constraints, risks/opportunities and requirements to transition to new supply source. Assess and resolve technical, regulatory, manufacturing and supply chain issues in managing process transfers. Coordinate and lead multiple projects simultaneously, working with functional groups and stakeholders to drive project execution plans and contract deliverables as well as resolve potential conflicts. Develop detailed project plans and timelines to ensure the alignment and coordination of cross-functional groups. Managed project to consolidate primary and secondary packaging operations for 27 products to three existing network facilities, which will realize cost savings of over $25MM/year when fully implemented.Lead cross-functional, virtual, international team to consolidate formulation and packaging of seven pharmaceutical products for 11 Latin American markets to existing European facility.Managed the technical transfer of formulation and packaging processes for OTC and consumer packaged goods to third party manufacturers.

Finance manager providing support and stewardship to senior management. Evaluated demand forecasting with capacity gap analyses. Analyzed budget variances including run rate analysis, developed variance reports and highlighted trends/issues for senior management. Responsible for ensuring compliance of company financial policies, procedures and controls. Prepared monthly and year end accruals.Successfully developed and managed annual budgets of approximately $96MM for 12 clinical and scientific departments within a variance of ± 2% with a strong focus on trend analysis and risk valuation/mitigation. Developed and provided detailed analysis to evaluate variances from annual budget plan and quarterly forecasts; prepared ad hoc financial reports in alignment with scientific and operating strategies for management reviews.Finance transition team member for the acquisition of a privately held pharmaceutical company. Integrated the company's operating budget and activities into existing finance systems without disruption.

Managed multi-product, manufacturing facilities (cGMP) that produced active pharmaceutical ingredients (API). Responsible for achieving all department financial, safety, environmental, quality, supply and production schedule KPIs and operational metrics. Supervised staff of 16 supervisors/engineers and 50 chemical operators. Resolved labor issues and conflicts. Coordinated with support departments (safety, maintenance, engineering, quality, environmental, materials management) to achieve department and site objectives. Manage and control department expenditures.Increased production of a key product (revenue > $2 billion) to meet market demand while maintaining all quality specifications and without disruption to other facility processes.Re-started production of an idle production facility after an extended shutdown to achieve increased production during the expansion of product line.Awarded Special Achievement Award for analyzing labor agreement and making recommendations to reduce expenses by simplifying processes and administrative procedures while maintaining flexibility, resulting in $100K annual savings.Planned and reviewed department profit plan; reviewed and analyzed monthly financial and production performance to achieve department budget.

Manufacturing project lead in matrix organization responsible for the production of APIs. Planned, coordinated activities and provided technical support in the production of APIs, including regulatory compliance, safety assessment, process troubleshooting and resolution, process monitoring and capital projects. Analyzed processes and implemented measures to decrease cycle times and reduce product costs. Recommended and implemented corrective and preventative actions to reduce manufacturing excursions. Designed process fits for new or expanding products; developed cycle time, labor and product cost estimates. Developed processing SOPs and new equipment installation/operation qualification and validation procedures. Trained operations staff. Managed projects leading to increased efficiencies, lower costs and improved reliabilityManufacturing project lead for the $60MM capital renovation of a pharmaceutical manufacturing facility.Implemented process change to increase dorzolamide process yield by 1%, resulting in $250K annual savings.Designed and implemented new process for charging anhydrous HCl to existing chemical process, reducing worker exposure while increasing efficiency and process safety.Awarded Special Achievement Award for maintaining regulatory compliance under strict NJDEP regulations for extremely hazardous substances (NJTCPA).

Engineer for capital and maintenance projects in research facilities. Planned, monitored and controlled costs to meet maintenance/project schedules. Supervised contractors for the maintenance/repair of specialized equipment. Validated chemical process equipment as part of a new $100MM research pilot facility. Consulted with equipment vendors to evaluate new process equipment and make recommendations for purchase and use.Planned and managed emergency installation of generator for sterile air system in a research facility; installation allowed the facility to operate uninterrupted during a period of high activity.Directed engineering efforts to rebuild and refurbish small scale chemical process equipment allowing the avoidance of new capital purchases.

Managed production of pharmaceutical intermediates in a multi-product facility with responsibility for quality, safety, environmental compliance, supply schedule, labor relations, cGMPs and costs. Supervised and coached four first line manufacturing supervisors and engineers with varying levels of experience.Optimized process operations to achieve a 2% increase in product yield for the clorsulon crude process, resulting in $150K annual savings.

Master Of Business Administration (M.B.A.), Finance, General; Operations Management

Bsche, Chemical Engineering