Matthew Fahey

Supports the functional strategy and operational direction for the Development and Pre-Commercial Services (DPCS) business. Collaborates with stakeholders across ELT, Project Management, Technical Services, Manufacturing Operations, Supply Chain, Packaging, and Finance to execute business strategy. Responsible for the implementation, maintenance, and review of systems and tools required to ensure consistent, technically sound, high quality business proposals. Works with cross-functional teams to optimize CRM and IT systems as it pertains to client engagement, proposals and projects. Supports global implementation and further optimization of ERP system.

Leads cross-functional teams and continuous improvement initiatives for the standardization of development and clinical proposal offerings through template design, technical content, scope packages, and costing tools while adhering to business objectives and financial targets. Embedded into BD and Contracts/Legal group to ensure harmonization and drive towards business unit targets with adherence to policy and procedures. Represents development and clinical capabilities at tradeshows. Supports commercial proposal development as an extension of the commercial proposal team to ensure timely delivery of proposals. Continuously involved in a team that evaluated filling assets and business requirements that led to selection and implementation of a new filling line for the clinical business unit. Lead a cross functional team to revise Simtra “Contact Us” form for client inquiries and improved TAT for inbound lead responses from 5+ business days to <1 business day. Leads the inbound client requests from the Simtra webpage as the 1st point of contact for Simtra; representing Simtra brand and presenting capabilities and offerings. Works with Legal, Sales, and Contracting groups to overhaul and streamline the contracting processes from CDA initiation to MSA execution. Coordinates between multiple functional groups across US and EU sites to implement ERP system for Development and Pre-Commercial Services business unit. Supports multiple internal teams for CRM improvement initiatives, capabilities updates and paper presentations, and financial teams for asset utilization and capacity visibility.

Evaluated the existing commercial, clinical, and development business contracts for Baxter during due diligence. Provided current industry guidance on pricing and developed a scalable staffing model to support the financial targets for the business model. Upon acquisition, role was converted from advisor to full time member of Simtra corporate.

Led strategic initiatives to optimize proposal development and pricing for the Bioservices business unit. Developed, standardized, and implemented a new costing and pricing model that encompassed capabilities for development offerings, drug substance manufacturing, and sterile injectables manufacturing. Provided technical assessments and strategic recommendations for opportunity fit and placement across North American sites. Led evaluation efforts for an automated proposal development software system and developed training material for end users. Developed and refined sales questionnaires with SMEs to streamline scope development for proposals. Generated detailed, accurate, and compelling proposals across diverse service offerings, including development services, drug substance, and drug product to support client programs in mammalian, microbial, viral, and plasma modalities.

Member of the Global Cell & Gene Therapy proposals team responsible for evaluating new client opportunities and developing custom-tailored proposals for sites in North America and Europe. Forecasted multi-year program costs for innovative processes in collaboration with subject matter experts. Presented pricing and costing strategies to sales team decision makers during bid defense meetings. Conducted bi-annual reviews of existing programs to assess profitability. Coordinated project handoffs to the project management teams sites upon contract signature. Drove standardization in template design, offerings, and costing models to reduce turnaround time for proposal submission

Led the strategic proposal development for inhalation opportunities at the Catalent Morrisville Site. Managed the process from receipt of the RFP to issuance of the proposal by liaising with project management, sales, operations, finance, and clients to ensure accurate, timely, and profitable proposals. Supported client relationship building by handling information requests and facilitating communications between stakeholders. Led proposal review calls with clients to finalize project scope while upselling Catalent capabilities. Collaborated with sales to leverage market data for competitive pricing. Maintained and updated proposal templates and standard language packets to facilitate faster turnaround times and created reports in our CRM system to track proposal metrics.

Team lead for inhalation product development projects. Developed and validated analytical and inhalation-specific performance methods. Drafted and reviewed critical documents, including CoAs, SOPs, and protocols while driving continuous improvement initiatives and distilled best practices to teams within the department. Supported ANDA and NDA filings through product development studies. Trained analysts in best practices that allowed for a significant increase in testing throughput. Assisted formulation engineers in manufacturing non-GMP pilot-scale batches. Managed laboratory inventory and coordinated with external vendors for instrument maintenance, calibration, and setup.

Performed in-vitro release testing (IVRT) and HPLC analysis for established clients to evaluate the performance and stability of semi-solid dosage forms. Assisted with HPLC method development, interpreted, reported, and presented analytical data. Supported the maintenance of a GLP-compliant laboratory environment and participated in the qualification, calibration, and maintenance of laboratory instruments.