Alexander Hart Email and Phone Number

- Design, implementation, and maintenance (Research & GxP) QA and QC programs, and the compliance infrastructure. Including but not limited to SOP system, training programs, and performing internal and external audits- Lead and manage inspections by regulatory agencies and commercial partners- Coordinate with regulatory agencies and other external auditors to build trust and confidence in SG US TEC’squality management systems- Lead quality input on contracts and serve as the primary contact for the negotiations of quality and technicalagreements- Work with SG US TEC’s external suppliers including contract labs to ensure consistent quality and compliance- Direct development and implementation of quality systems to ensure product reliability, quality, efficacy,compliance to applicable SOPs, and GxP regulations- Monitor and management of adherence to the overall Quality and Compliance budget- Develop, analyze, and report business metrics and highlights- Review trends and report to CTO and Site Leadership on regular basis- Review, approve, and direct implementation of changes to systems, processes, and documentation (e.g., SOPs,Specifications, Protocols, Reports), both internally, with clients, and vendors- Experienced with FDA/EMA/MHRA regulations, ICH guidance documents, and industry standards in GxP

- Project Management/ Task Force Lead for Covid Drug Product- Support the development of country quality strategic initiatives base on risk and business needs, in closecollaboration with key stakeholders- Lead continuous inspection readiness for Quality Assurance- Independent quality review and approval of cGMP operation activities- Review and approval of master and executed documentation including SOPs, test methods and results,specifications, batch records, method validation documents, raw material and supplier information, and allapplicable product and facility documentation- Review and approval of investigations and corrective and preventive plans (CAPAs)- Disposition of raw materials, components, drug substance intermediates, starting material, and drug product- Responsible for the oversight and management of Suppliers, Contract Test Laboratory and ContractorProgram, including periodic assessments - Communicate and influence internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations- Additional responsibilities include but are not limited to the following:o Lead and drive continuous improvement activitieso Regulatory filings; author, review, and/or approvalo SME for document technical and/or compliance review and approval o SME for investigations, change controls, CAPA plans,o Process Quality Monitoring/ Data trending

- Lead project management efforts associated with Drug Substance/Drug Product manufacturing, release, stability, and related regulatory filings- Support manufacturing process improvements, process validation, analytical method development and transfer, and product launch related activities in a project manager capacity- Managed AG-270, AG-636, and AG-946 Projects from early to late phase clinical trials across five sites in three countries - Review all Quality Control related documents in support of finished drug products, drug substances, reference standards and stability samples, including but not limited to; specifications, qualifications, method validations/transfers, protocols and reports, and stability protocols and reports- Support writing, review, publication and filing of regulatory documents and interactions, including those associated with INDs, IMPDs and NDAs- Author, review, and approve Change Controls, CAPA’s, QC deviation reports, and participate in out of specification (OOS) and out of trend (OOT) investigations where required- Manage Quality activities and provide updates in weekly meetings both with external partners and internal groups- Communicate any discrepancies, issues, or questions to external test sites, Agios Analytical project leads, and management- Coordinate and Trend stability data performed at external CMOs/CROs- Ensure all QC activities are in accordance with regulatory and industry guidance’s - Ensure that all testing is completed and recorded according to Good Documentation Practices and relevant SOPs

- Partner with Corporate Compliance, Quality Assurance, Global Information Services, and Operations-Facilities in execution of Technical Operation’s functions- Review and Author technical methods and cGMP reports.- Analysis of cGMP and NonGMP samples utilizing various analytical techniques – HPLC, Dissolution, GC, KF, X-Ray Diffraction, UV-Vis, FT-IR, etc., including method validation, method transfers and stability reports per cGMP requirements.- Review of cGMP equipment and software qualifications and repair.- Ensure compliance with all Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP) regulations.- Document all analytic activities and provide written summary reports of investigations.- Review documentation of other laboratory personnel.- Assist in the investigation of aberrant results, Track-Wise events, deviations, CAPA’s.- Train new laboratory personnel (individual/group) on test methods as required.

- Perform HPLC/GC analysis of raw materials, intermediates and finished products.- Author material comparability assessments.- Input analytical results into Stability Data Reports and prepare documentation of test procedures per cGMP requirements.- Attend/Present meetings, projects, and red-line events.- Facilitate/Implement new practices as a Change Agent within the laboratory to optimize cycle time and efficiency.- Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.- Conduct chemical analysis of various carbohydrates and proteins.- Calibration, maintenance and review of analytical equipment including annual/semi-annual PM’s and IQ, OQ, PQ’s of new equipment.- Ensure compliance with all Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP) regulations.- Document all analytic activities and provide written summary reports of investigations.- Review documentation of other laboratory personnel.- Assist in the investigation of aberrant results, Track-Wise events, deviations, CAPA’s.- Assist in the development of new analytical methods and draft protocols, technical reports, SOPs, and Empower processing/method set transfers.- Train new laboratory personnel (individual/group) on test methods as required.

- Perform HPLC analysis of API raw materials, intermediates and finished products usingvarious solvents: affinity, hydrophobic interaction (reverse-phase), hydrophilic interactions(normal-phase).- Input analytical results into Stability Data Reports and prepare documentation of testprocedures per cGMP requirements.- Support routine activities of quality control (QC) involving testing and inspection ofcomponents, intermediates, and finished products.- Perform job functions in accordance with all applicable Standard Operating Procedures(SOP), federal and state laws, Occupational Safety and Health Administration (OSHA)guidelines, health authority regulations, and departmental processes.- Conduct rheological and chemical testing of adhesives and adhesive products.- Calibrate and maintain analytical equipment including IQ, OQ, and PQ of new equipment.- Ensure compliance with all Good Documentation Practice (GDP) and Good ManufacturingPractice (GMP) regulations.- Document all analytic activities and provide written summary reports of investigations- Check documentation of other laboratory personnel.- Assist in the investigation of aberrant results, Track-Wise events.- Assist in the development of new analytical methods and draft protocols, technical reports,and changes to SOPs and STMs.- Train new laboratory personnel on test methods as required.

Enhanced knowledge of lab equipment; followed standard procedures in preparing labs for use by studentsIndependent Undergraduate Research Project – Phylogenetic investigation of selected Habranthus species, native southeastern U.S. Zephyranthes species and selected Mexican Zephyranthes species The relationship between rain-lilies classified in Habranthus and Zephyranthes has been problematic. We conducted an ISSR fingerprinting study to gain insights into the generic relationships among rain-lilies. The gels were scored and the data used to build a matrix which was analyzed in PAUP* 4.0b2. The tree that was generated from the matrix in MacClade 4.0 revealed that Habranthus taxa form a monophyletic clade. Additionally, the Habranthus clade was sister to a clade comprising the native southeastern species of Zephyranthes and to a clade comprising selected Mexican taxa. At this time we are not recognizing these Mexican taxa as a genus distinct from Zephyranthes but recommend additional investigations to clarify the taxonomic level of relatedness. The three clades that we produced have also been noted in an independent ISSR study by A. Spurrier and in DNA sequencing studies by A. Meerow.

- Worked as a member of the drug delivery consulting team conducting secondary researchand analysis on key delivery platforms.- Tracked and analyzed the pharmaceutical pipeline of biomolecules requiring parenteraldelivery.- Prepared summaries and presented work to core team.