Capabilities
APEX brings seasoned, professional expertise that has been demonstrated in the execution of work and delivery of results. The following represents career accomplishments of APEX Members and Partners:
Business
- Designed, developed, and implemented comprehensive, enterprise-wide process business solutions for business units, regions, functions, and groups. Solutions included conducting assessments, developing plans, managing resources, facilitating large working sessions, and executing implementation.
- Designed, developed, and implemented comprehensive strategic planning processes for business units, regions, functions, and groups. Processes included assessing current state, analyzing and presenting results, facilitating creation of long and short-term direction, establishing key performance indicators, and generating action plans.
- Drove cross-functional design, development, and implementation of numerous business processes (Product Life-Cycle, Global Commercialization, Demand Planning and SIOP Integration, Business Development, Legal, HR, Marketing, Proposals, Contracting, Sales Methodology).
- Executed team leadership responsibility within a Corporate Business Excellence Group that provided Baldrige-based assessments, enterprise-wide improvement initiatives, Lean Six Sigma tool support, and Green/Black Belt training and coaching.
R&D / Engineering
- Developed and implemented complete life-cycle Product Development Processes fully compliant with ICH and QSR requirements, using collaborative facilitation techniques to align organization-specific roles and responsibilities.
- Held technical and executive responsibility for building, staffing, and maintenance of state-of-art laboratories incorporating FDA, ICH, and USP guidelines.
- Provided industry-leading expertise in chemical structure determination, analytical method development and validation.
- Provided leadership and management of pharmaceutical Stability Operations and Documentation systems.
Manufacturing / Service
- Provided leadership and management in Class IIb device manufacturing including Line Operations Management and Line Optimization, Value Stream Mapping and analytics, Performance Metrics, Continuous Improvement, and documentation architecture.
- Provided technical development and execution of pFMEA, control plans, work instructions, and inspections.
- Provided leadership and management in Pharma (API) manufacturing including Line Operations, Critical Systems, & Support Labs with in-depth cGMP / ICH expertise incorporating regulated documentation (batch records, DMF, etc.).
- Led facility start-up and expansion projects, including piloting and validation (IQ, OQ, PQ).
- Designed, developed, and implemented Supplier Management programs (Audit, SNC, NCR, CAPA) based on Global Harmonization (GHTF) guidelines and the QSR.
Quality Management / Operations / Engineering
- Warning Letter remediation of multiple quality system processes including a new Quality Manual and program management over projects spanning multiple departments and manufacturing lines.
- Provided technical leadership of production and process control elements including pFMEA, validation projects, and manufacturing procedures and work instructions.
- Designed, developed, and implemented Quality System processes through cross-functional facilitation, business process excellence methodologies, and technical writing.
- Provided Quality Engineering and Design Assurance support for product launch, design transfer, verification, validation, and risk management.
