Provide strong Sr. Leadership project management skills for the building and startup of a new 30k sq ft Quality Laboratory which will support the Spark analytical business functions for the new Gene Therapy Innovation center located in Philadelphia Pa. Conducted and completed design phase review of equipment and laboratory spaces, during the design phase. Successfully completed the design phase to support the transitions into issued for construction phase and aligned a plan to support commissioning phases of Laboratory Utilities with project and site engineering.

Provide support within the Emergent MS& T/Validation team, building Process Performance Qualification (PPQ) reports for Client 562. Report building includes (PPQ related deviation assessments, PPQ Data Summaries, and PPQ deviation Summaries). This includes collaborative efforts with cross-functional groups, (Engineering, Manufacturing, Quality, and Client representatives) ensuring report alignment.Conduct report comment resolution with cross functional groups to ensure alignment prior to official quality review and Group final review and approval within the Quality management system (Veeva).

Providing CIP Engineering solutions for Pfizer Rocky Mount North Carolina R3 Facility. Driving Cleaning cycle development activities using multiple CIP Skids with detergent delivery to multiple Filling systems, large and small volume Production vessels and associated transfer lines. Completed the project for the client October 2021.

• Provide expertise assisting with the remediation of site wide System Development Life Cycle (SDLC) Requirement Specifications (RS), and Automated test Specifications (ATS) according to project mitigation plan.• Review, Modify, updating and testing of existing SDLC documents based on existing Delta V code utilizing testing simulation sandbox and qualified systems.• Conduct team collaboration on best approach practices and implement findings within the SDLC frame work resulting in successful continued operations for multiple factories.

• Provide expertise assisting with the remediation of Laboratory control & systems relating to full life cycle environmental sample collection, and testing as relates to FDA observations.• Remediation efforts impacting Project Plan protocol writing, Gap to process execution, Process mapping, and SOP/Bio-control enhancement(s).• Provide team Leadership creating Baseline Evaluation matrix and communicating evaluation findings to cross-functional team Leadership.

• Lead the process engineering start-up teams (CRB & Shire) with the review and execution of commissioning protocols for Albumin, and Ig concentration and diafiltration skids. This included upstream feed and downstream purification tangential flow filtration systems within the Aseptic Iso 8 manufacturing core resulting in on time completion of start-up activities.• Provide frontline support for Anx and CMS (anionic and cationic) chromatography column packing activity resulting in column packing activity completion on schedule to include parallel Senior and associate level training metric being achieved.• Provide frontline support using Delta V and EBM cleaning and process execution platforms for start-up, shakedown and commissioning activities to include event management using Datavoke tracking system, resulting in statistical alignment for process characteristics and mitigation activities being completed. Further resulting in target start-up, shakedown and commissioning activities completed on time.• Provide leadership guidance in coordinating operational testing activities to include aligning resources with cross functional teams ensuring activities are driven to completion on schedule.• Provide Aseptic training to Manufacturing team during cleaning and process sampling activities to include protocol execution and sample submission. Resulting in senior and associate level meeting target training metrics.

Our team provides strategic business direction for Pharmaceutical contracting & consulting services that aligns with the Biopharmaceutical & Pharmaceutical industry. We specialize in partnering and performing directional work with Suburban Cleaning Service, Inc.; Flowers of Eden Inc.;EC Squared, Inc; Tunnell Consulting, VTS LLC and Black Diamond Networks LLC.

• Contracted to provide leadership for the Quality System Element teams with Consent Decree GAP observation mitigation within the CD Manufacturing operation teams, for the McNeil consumer Health care organization in Lancaster PA, Fort-Washington and Las Pedro facilities. Resulting in the successful consent decree return to operations and meeting Pilar objectives on-time ahead of schedule.• Executed gap and disconnect alignment using process excellence problem and solution statement tools to provide sustainable processes for long term success measurements. Resulting in harmonization metric being achieved across the organization.• Conducted QSE Standard to GAP alignment meetings with cross functional manufacturing groups, Quantic partners, ERC, and Base business quality teams from all sites resulting in the development of high level frame work for SOP’s, batch records and cleaning records.• Produced sustainable mitigation development in the areas of manufacturing controls, clean and clearance, weighing and dispensing, yield and reconciliation, SOP, batch record and logbook operations. Resulting in meeting regulatory agency and internal audit teams gaining harmonization within the quality elements. • Performed handshake meetings with the cross functional groups to provide organizational analysis, quality risk analysis, SOP, batch record, and logbook assessment to gain harmonization in meeting Quantic, ERC, and McNeil quality standard and FDA requirements.• Assisted Base Business Engineering, Quality Engineering & Maintenance with pre and post pillar Audit report writing for Environmental, Water and Pest Control Systems aligning with Quantic, ERC and McNeil quality standards and departmental procedures. Resulting in the report structure contributed to zero FDA observations and a sustainable methodology framework for the departments.

• Contracted to provide senior leadership with the engineering start-up activities of two large scale Millipore and Pall Ultra-filtration Diafiltration concentration skids interfacing with a Delta V operating platform for Merck Pharmaceutical division in Elkton VA. Resulting in the successful engineering campaign completion with higher yields than anticipated.• Assisted in drafting IQ/OQ & PQ documentation to support critical processing dynamics of the filtration operations resulting in project phase deliverables meeting schedule.• Supported base business engineering and technical service operations in managing engineering dry and wet shake down activity of the filtration systems, supporting vessels, and processing transfer lines. Resulting in lean strategy development to include meeting stag-gate timeline achievement ahead of schedule.• Conducted automated shake down protocol testing using the Delta V operating system resulting in zero defect to the primary and supporting equipment.

• Contracted to lead and manage the start-up activities and launch to market of Medimmune’s new Fill Finish Suite (Line-2) for the H1N1 Pandemic. Resulting in successful production of 34 million doses of H1N1 vaccine and 14 million doses of Flumist®.• Provided technical expertise for the technical transfer and implementation of an Inova® filling machine, and related automated filling Robot, and Paternoster equipment resulting in meeting start-up stage gate time lines being achieved.• Conducted protocol execution for water-filling, media filling, product consistency and full scale production in the class 100/ISO 5 aseptic filling environment for FDA pre-approval and final approval resulting in zero critical observations and successful product launch to market.• Conducted Aseptic behavior analysis and environmental assessments and draft recommendations for short and long term training requirements to be established for filling activities in the Class 10,000/ISO7 and 100/ISO5 environments. Resulting in a fully qualified production zone, and fully trained senior and associate level staff.• Managed Batch record development, implementation, execution and primary revision control for the Pandemic & Flumist® campaigns. Performed investigation and resolution of process related non-conformances using Track Wise investigational platform. Provided SME expertise for inspection readiness activities with the MHRA, European Union, WHO and FDA routine audits. Resulting in zero critical observation and the successful launch to market.

• Assist in the acquisition and development of a (MBE/WBE) PA and DE State Certification. Assist in the development of a Service Connected Disabled Veteran owned Janitorial and Custodial Supply Company.• Consult with client executives on the “going-green” requirements and assist in the development and execution of service plans of maintaining best cost, and best quality for a healthy work place environment.• Negotiate, draft, modify and execute service contracts according to proposed specifications.• Develop cross-functional business to business resources with key decision-makers that foster long term business relationships.• Conduct formal meetings with the Board of Directors and assist in the reporting of company business cascades.

• Hired as a full time Biopharmaceutical Manufacturing Associate III, for the production of Johnson & Johnsons’ new biopharmaceutical drug product Remicade®. Promoted to Biopharmaceutical Manufacturing Specialist within 3 years of hire.• Provide front line manufacturing technical expertise for the start-up of two downstream process suite processing equipment and related cleaning equipment. Resulting in market launch of the biopharmaceutical product Remicade® ahead of schedule.• Provided technical leadership in investigational analysis, CAPA generation and atypical event notification utilizing Track Wise operational platform.• Lead review of DDS and FRS review for the implementation of a Delta V automation control platform on several Millipore Ultrafiltration/Diafiltration Skids to include associated stick build units and transfer lines. Conducted commissioning and validation protocols for the Millipore filtration skids, stick build process vessels, Chromatography skids and associated transfer lines. Resulting in the successful completion of the IQ/OQ/PQ activities which enabled engineering runs to be completed ahead of stage gate schedule.• Draft and execute area SOP’s to include Batch record development and consistency run execution of the written records. Resulting in the full scale production utilizing SP chromatography, Virus removal, Ultra filtration & diafiltration, Q sepharose chromatography, and final fill methodologies according to approved batch records and SOP’s.• Senior lead in the training of new and existing team members utilizing OJT, and classroom techniques.

• Hired as a full time Manufacturing Associate I employee for the start-up activities in the Fermentation and Purification areas of SmithKline Beecham’s first Biopharmaceutical worldwide biological drug product supply line. Promoted to the Senior Manufacturing Associate III level within 4 years of tenure.• Performed start-up activities IQ/OQ/PQ of 1k and 5K processes and buffer process for contract manufacturing of a recombinant protein. Assist Validation/Engineering and Manufacturing groups in the execution of protocol procedures.• Led extensive group training in the area of packing columns in relation to Prosep-A, Q-sephrose, HIC, Cellufine and IMAC EMDU resins for chromatograph operations.• Senior Lead in the operations of Amicon chromatography, Millipore UF/DF processing skids.• Submission of write-ups pertaining to Deviation & Exception Reports and change control submission according to existing SOP’S.• Involved with the technical transfer of the purification process for Factor 9 (a biological blood clotting product) to contract manufacturing organizations.