Kathy Powers Email & Phone Number

Pharmaceutical division, a leader in development of generic drugs, the manufacture of API’s, and bulk & dosage pharmaceuticals.; – currentResponsible for leading, facilitating and managing high priority cross-functional teams to meet corporate goals.• Lead branded and generic drug development projects through stages of development from initiation through launch• Lead, direct, collaborate and motivate high level teams comprised of leaders in their functions• Manage communication to teams and to Sr. Management regarding development progress• Track team progress through detailed scheduling and financial planning using Microsoft Project and Primavera system• Collaborate with teams to meet or exceed schedules and budget• Negotiate and collaborate with team members to reach concensus on plans• Development of training programs and onboarding plans for new project managers• Lead Project Managers in a continuous improvement forum• Responsible for managing and budgeting projects in the $60 to $100M cost range• Develop risk management plans that include mitigation and contingency strategies• Manage Design Stage Reviews with the OpEx Director and team• Present regularly to Sr. Management on team progress, milestones and recommendations• Present S&T project status to potential clients to support BD&L activities, participate in BD&L interviews• Collaborate with finance on presenting budget and financial information to clients• Provide recommendations on process and stage gate exit requirementsesponsible for leading, facilitating and managing high priority cross-functional teams to meet corporate goals.• Volunteered at a local university workshop on using Project Management tools to manage budgets

Greater St. Louis Area

Responsible for leading, facilitating and managing cross-functional teams to meet corporate goals.• Lead generic projects successfully to ANDA filing within targeted timeline.• Experienced in managing complex global projects with global team members• Starting up new tamper resistant teams and mentoring two project managers in ANDA development as well as PDP process.• Develop risk management plans that include mitigation and contingency strategies.• Develop project schedules and work with team in ensure team alignment and consensus.• Work with PMO office to pilot new systems and plans. • Developed technical review system with management to ensure organization agrees with team progress.• Have been trained on DFSS and work with OpEx Director to manage the team through FMEA’s, QBD analysis and Design Stage Reviews.• Negotiate resource requirements with functional leads• Present regularly to Sr. Management on team progress and milestones• Led clinical team through development of new SOPs and met the goal of 80 SOPs fully approved and executed within the 8 months. • Was asked to quickly take over a floundering team to manage the organization across global divisions through a global supply shortage of a key raw material. Resulted in maintaining supply for critical product lines in the imaging and pharmaceutical divisions. Met regularly with the President of other divisions and the Vice President of Manufacturing to outline plans.• Manage training team for the Project Management Organization. Set up training program and tracking system. Arrange for one to two seminars for Project Management Organization per year. Enable efficient way for PMs to maintain their PMP certification as well as increase knowledge of the whole team.

Responsible for leading, facilitating and managing cross-functional teams to meet corporate goals.•Lead generic projects successfully to ANDA filing within targeted timeline.•Experienced in managing complex global projects •Developed technical review system with management to ensure organization agrees with team progress.•Develop risk management plans that include mitigation and contingency strategies.•Develop project schedules and work with team in ensure team alignment and consensus.•Have been trained on DFSS and work with OpEx Director to manage the team through FMEA’s, QBD analysis and Design Stage Reviews.•Negotiate resource requirements with functional leads•Present regularly to Sr. Management on team progress and milestones.

Increased purchasing management responsibilities by adding product management (marketing) functions, including direct P&L responsibility for $50M bulk pharmaceuticals and reagent product line manufactured in Phillipsburg, NJ, while maintaining Strategic Sourcing responsibilities.•Phillipsburg product profitability had been in decline for five years. Focusing on customer service, reducing product cost, and negotiating better prices lead to 10% profitability improvement in first year.•When the sales force identified new business opportunities, was responsible for sourcing API’s and bulk pharmaceuticals. Negotiated cost effective positions that resulted in $25M in new business.•As St. Louis plant changed strategic direction and discontinued production of some inorganic salts, led the strategic sourcing effort in identifying and developing alternate sources, and negotiated exclusive worldwide marketing contracts for the supplier’s product. Enabled the division to retain $20M in business.•Managed three direct reports.

Established and managed relationships with outside manufacturers supplying API’s and bulk drugs as well as contract manufacturers who were responsible for processing and services consistent with specified levels of quality, delivery, and total cost to support pharmaceutical product line. Had overall responsibility of inventory planning and material requirement planning.•Designed policies and procedures for an independent out-sourcing business unit. Negotiated and maintained global supply agreements and partnerships for $80MM business. •Integral member of business team to develop business plans and contracts. Interfaced routinely with all management levels of Sales, Research and Development, Legal, Quality, and Regulatory Compliance. •Managed contractual arrangements with toll manufacturers for value added processing of API’s and excipients. This value added business grew from zero to $18MM in six years.•Set up 12 contract manufacturing companies and agreements, to include quality approval, technical review and approval•Worked with Quality Manager and Quality Auditor to improve the quality of partner companies in Mexico, Europe, Israel and Japan.•Set up systems for customer audits of suppliers and CMO’s.•Developed team approach between procurement and quality to improve communication, cGMP training, auditing, customer complaint resolution, DMF development and regulatory compliance of suppliers and toll processors. Led to unified goals and priorities for more efficient workflow and interdepartmental support.

International Business, A

Bachelor Of Science, Business Administration; Chemistry

Clinical Research Management, A