Manager Validation/Engineering

• Aug 2023 - Present

Sr Validation Engineer

• Jul 2022 - Aug 2023

Oversight of the Quality Validation of Processes and Equipment to manufacture API Drug Substance. Lead Remediation Subject Matter Expert to address Validation deficiencies. across the organization. Responsible for creation of Validation Department and implementation of robust processes. Oversight of the Quality Validation of Processes and Equipment to manufacture API Drug Substance. Lead Remediation Subject Matter Expert to address Validation deficiencies. across the organization. Responsible for creation of Validation Department and implementation of robust processes.

Quality Assurance Manager - Validation Lead

• Jan 2020 - Jun 2022

Absorption Systems Boston (CRO) Medford to Woburn (relo) Manager Quality Systems – Validation Lead 01/2020-present Oversight of Quality Assurance Unit including development and implementation of the quality management systems. Establish Validation and Equipment Qualification program. Develop effective quality processes to ensure efficiency and standardization. Devise, review and approve documents to support robust processes. Oversee employee performance and provide cGxP training to ensure compliance. Manage and approve vendor suppliers. Perform and facilitate Regulatory and Sponsor Audits. Show less

Senior Validation Specialist

• May 2019 - Sep 2019

• Oversight of existing QC lab and implementation of new instruments to a new dedicated space. • Designated audit response lead from previous MGR’s internal audit observations. • Author, execute and approve URS, ERES, and IOPQ’s within the Validation department. • Assist QC with method development on previous methods transferring to new not for like equipment. • Ownership of Validation and Engineering Kaizen process improvement to revamp the validation processes. • Oversight of existing QC lab and implementation of new instruments to a new dedicated space. • Designated audit response lead from previous MGR’s internal audit observations. • Author, execute and approve URS, ERES, and IOPQ’s within the Validation department. • Assist QC with method development on previous methods transferring to new not for like equipment. • Ownership of Validation and Engineering Kaizen process improvement to revamp the validation processes.

Sr Specialist Technical Writer / Project Manager

• Oct 2018 - May 2019

• Follow-up, track and drive completion of activities in a cross functional-wide project from conception to close-out. • Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of closeout. • PM for Change Control to closeout overdue assessments and CAPA’s for process changes and scale down activities.• Oversee facility site closeout validation protocols, decommissioning of equipment in Maximo.• Facilitate collection, entry, tracking and reporting of contract site performance metrics identify improvement opportunities for site performance; issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT) Show less

Senior Process Development Engineer Drug Product

• Oct 2017 - Oct 2018

• 200% visual inspection lead to ensure 100% accountability of released FDP in house as well as commercial material supplied to patients.• Develop continuous processing technologies and techniques to relevant unit operations to support tech transfer. • Critically evaluate new processes for identification of process improvements and requirements to support optimization.• Analyze and document the economic value of proposed and new process concepts to support robustness of next-gen products. • SME to support Deviations, Change Controls and CAPA’s as well as SOP periodic review across site. • Equipment lead and Maximo end user to ensure PD lab-based equipment is in compliance.• Contribute to CMC and IND filings to support manufacturing changes.• Lead for PD pre-inspection and corporate internal audits (with no observations noted). Show less

Quality Control Consultant

• Mar 2017 - Aug 2017

• Prepare Quality unit QA/QC for upcoming FDA inspection. • Review Quality policies and procedures including QC Methods • Identify and assess gaps in testing methods and make recommendations to meet regulatory requirements for GMP manufacturing. • Support with NDA filing activities which include reviewing and approval of protocols, studies and submissions. • Assess and review clinical complaints and deviations. • Perform data review to support process changes • Prepare Quality unit QA/QC for upcoming FDA inspection. • Review Quality policies and procedures including QC Methods • Identify and assess gaps in testing methods and make recommendations to meet regulatory requirements for GMP manufacturing. • Support with NDA filing activities which include reviewing and approval of protocols, studies and submissions. • Assess and review clinical complaints and deviations. • Perform data review to support process changes

QC Project Manager / Planner

• Jan 2016 - Jan 2017

• Communicated on a Global platform, STAB and QC testing requirements with 100% on time deliverable. • Managed oversight to QC labs to ensure adherence testing to meet contractual manufacturing requirements. • Resolved Capacity issues (minor equipment and labor issues) utilizing a QA approach • Developed priority lists based on demand requirements while mitigating risk. • Championed LIMS Global integration Kaizen event through completion. • Informed customers of product availability, negotiated release due dates and mitigated testing issues. • Monitored performance metrics for the assigned products (i.e. quality attainment). Show less

Project Manager

• Jun 2014 - Jun 2015

• Ensured Technical Transfer activities were vetted with business development and technical representatives to transition client interfacing project work in-house • Liaison between stakeholders, executive team members, clients, project team members, and functional groups to ensure the delivery of quality products within contract scope of work. • Prepared detailed project schedules including identification of major milestones for overseeing, controlling, communicating, and managing all activities required to complete client projects on time. • Monitored and controlled project costs and provided project updates with executive management and external clients. • Performed in depth Risk Assessments and Risk Mitigation strategies both internally and externally. • Demonstrated proficiency in Quality Systems pertaining to Investigations, Deviations, CAPA's and Change Controls utilizing SAP and Track-wise platforms. • Support regulatory commitments for CMC and BLA filings as technical SME. Show less

Technology Transfer / Drug Delivery Specialist

• 2013 - 2014

• Oversight for process development scale-up and Technology Transfer of Drug Substance to CMO production facilities to manufacture liquid, lyo, vial, and syringe final Drug Product. • Created, executed process development studies to support process changes for several commercial products. • Assessed CMO capabilities by performing in depth Risk Assessments as well as drafting Engineering protocols to assist in the compliant Technology Transfer to commercial facilities. • Supported CMO GMP manufacturing start up, review validation documentation for multiple equipment processes to ensure protocols and equipment were in a validated and compliant state prior to PV runs. • Collaborate with CMC and analytical cross functional teams to support regulatory filings. Show less

Project Specialist

• 2012 - 2013

• Direct oversight of Drug Product filling liquid and lyo operations including incorporating feedback utilizing a Quality systems background. • Supported the business and operational needs of the External CMO team to meet supply needs. • Maintained project tools by updating (schedules, time lines, plans, metrics, dashboards and trackers). • Proactively drove resolution of manufacturing issues, fostered collaboration throughout the internal organization and external partners. • Direct oversight of Drug Product filling liquid and lyo operations including incorporating feedback utilizing a Quality systems background. • Supported the business and operational needs of the External CMO team to meet supply needs. • Maintained project tools by updating (schedules, time lines, plans, metrics, dashboards and trackers). • Proactively drove resolution of manufacturing issues, fostered collaboration throughout the internal organization and external partners.

Lead Process Investigator

• 2012 - 2012

• Managed investigations from date of discovery through QA approval with a concentrated focus on Continuous Improvement. • Performed detailed investigations to generate high quality compliant reports as well as support defending FDA observations. • Utilized in-depth chromatography and purification expertise to aid in timely resolutions of manufacturing processes. • Demonstrated ability to meet strict established time and work commitments. • Managed investigations from date of discovery through QA approval with a concentrated focus on Continuous Improvement. • Performed detailed investigations to generate high quality compliant reports as well as support defending FDA observations. • Utilized in-depth chromatography and purification expertise to aid in timely resolutions of manufacturing processes. • Demonstrated ability to meet strict established time and work commitments.

Bio-Manufacturing Manager

• Jun 2008 - Feb 2011

• First hire of management team to lead facility from re-initiation to re-implementation of Phase I/II/III vaccine production. • Revised BLA and CMC to support filing for approval in the US post tech transfer from France. • Demonstrated leadership, direction and mentoring to ensure departmental alignment and delivery of objectives. • Optimized production implementation of new equipment and process improvements through Phase I/II/III development. • Provided technical support to maintain and improve quality, compliance and operational efficiency by resolution of complex process problems. • Aligned key site objectives by managing timelines and schedules in Microsoft Project. • Subject Matter Expert (SMA) in procedural aseptic manufacturing operations. • Authored, revised, and trained employees on BR / SOP's along with supporting and updating CMC's for IND submittal. Show less

Process Development Engineer

• 2011 - 2011

• Developed client processes and execution of the Engineering / Phase appropriate runs in a manufacturing setting. • Authored SOP's for the operation of equipment and manufacturing processes in the clean room facility. • Developed batch records and wrote reports. Troubleshoot amended and accommodated aseptic formulation and fill of drug product under cGMP guidelines. • Executed Engineering functions for all Quality system elements including CAPA's, DR's, Change Control, design and document controls. • Specified and procured new process equipment including FAT testing offsite Show less

VT&E Engineer

• 2008 - 2008

Process Improvement Engineer in the Vaccine, Technology and Engineering Group Process Improvement Engineer in the Vaccine, Technology and Engineering Group

Bio-Pharamceutical Manufacturing Specialist

• Jan 2006 - Jul 2007

• Purification specialist of recombinant proteins utilizing Tangential Flow Filtration and chromatographic procedures in an aseptic GMP production compliant facility. • Investigated atypical events, supported validation with new process start-up and BPT with implementation and special studies. • Collaborated with the engineering team on qualification lots, runs and overall process with any discrepancies. • Created, maintained, and revised SOP's / batch records. • Designated area GMP and Safety auditor - Yellow belt Lean Six Sigma certified. Show less