Katherine Rogers Email and Phone Number

 Oversees a staff of 35+ direct and indirect employees in Quality Control. Responsible for QC laboratory design, build, equipment selection and qualification, and staffing/hiring plan for the Abzena Sanford, North Carolina facility. Ensures that the analytical control strategy is aligned with Abzena's sourcing strategy for products. Leads the quality control plan for products. Acts as the primary contact representing QC to other departments, CMC team, Regulatory, Manufacturing, AMD/PD, and Quality Assurance. Contributes to analytical chapters in IND/IMPD/BLA/MAA. Ensures a continued information flow among other departments and external collaborators/partners. Represents QC at authority meetings and teleconferences for analytical questions. Contributes to development of an operating model and continuous improvement of platforms based on quality control plans for the complete product life cycle. Owns publishing and conference participation strategy of products for quality control in alignment with the company strategy. Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.

Selected by SLT for a development opportunity. Responsible for running weekly SLT meetings which included agendas, leading discussions and sending out meeting minutes. Assisted and communicated with executives in decision-making, program management, and initiative implementation.Assist the human resources department with new hires, including documentation and onboarding, and collaborate to address and resolve all employee concernsOversaw daily operations in collaboration with senior managers and department leaders, and performed administrative tasks such as managing calendars, generating correspondence, maintaining hard copies and electronic files, planning and coordinating annual corporate meetings, and scheduling facilities.

 Senior Leadership Team member and site QA head for the Alnylam Alewife Manufacturing Facility. Partners with Alnylam leadership to develop, deploy and continuously improve GMP standards and practices by aligning with QA leadership at corporate (Kendall Square – Cambridge, MA) and Alnylam’s new manufacturing site in Norton, MA. Ensures continuous GMP-compliant/audit-ready state of the Alnylam Alewife Facility. Provides QA Review and approval of deviations, change controls, CAPAs, DDRMs and SCNs. Implements the quality management system (QMS) procedures. Leads disposition of Raw materials and Bulk Drug Product Approve SOPs, Master Batch Records and protocols Understands and assures conformance to regulations. Interfaces with regulators during inspections. Manages coaching, training, and development of subordinates

 Supervised QC staff to perform duties in support of manufacturing, in support of the Facility, and as necessary development activities; ensured appropriate level loading and communication of priorities. Developed staff to improve individual and departmental performance Lead functional area method transfer/qualification/validation activities as necessary Troubleshot issues related to laboratory procedures and assay performance Provided support to audit teams for internal and vendor audits Continuous, inspection ready operation of the QC laboratory. Performed of QC analytical testing with focus on HPLC methods (i.e., HPLC, Particle sizing, quality assays, fluorescence-based methods (Plate Reader)) on raw materials, bulk and final drug product, including in-process testing. Performed QC Management review data related to routine and non-routine function (i.e., testing, investigations, equipment qualifications, etc.). Contributes substantially to the interpretation of data including trending of analyses. Supported development and implementation of operation systems (i.e., equipment maintenance, logbooks, laboratory housekeeping, analytical life cycle, sample submission, etc.) Ensured continuous GMP-compliant/audit-ready state of the Alnylam Alewife QC testing laboratory. Implemented new technology/instrumentation in the QC laboratory including Empower3 FR5, Labware LIMS, and recommends laboratory and equipment-related improvements. Identified deviations from QC methods and Alnylam policies, performs investigations (i.e. OOS, Atypical, etc.) and then developed appropriate CAPA, as applicable. Formulated solutions to laboratory issues through hypothesis testing. Collaborated with internal departments efficiently and effectively (e.g. Manufacturing, Quality Assurance, Process Development, and Regulatory Affairs); also, with external contracted testing laboratories, consultant/contractors, and vendors.

Oversees quality activities associated with manufacturing, testing and disposition of commercial material.Reviews/approves CMO batch records and associated GMP documentation.Oversees Stability Program initiatives and supporting ongoing regulatory filings.Monitors, reviews and approves analytical/stability data in support of ongoing regulatory filings.Interfaces with cross functional groups to initiate/maintain change controls and CAPAs associated with CMO operations.Leads quality aspects of technology transfers for manufacturing sites and laboratories.Leads/supports internal and external audits.Supports regulatory inspections and leads inspection preparation teams as needed.

Provided quality and compliance support for all aspects of process development, commercial manufacturing, testing and release of drug substance/drug product.Supported internal and external quality systems and operations such as facilities/equipment, materials, production, laboratories, packaging/labeling and quality. Assured compliance with current GMP’s.Reviewed/Approved Batch Records (including APS, Engineering and Development runs) and other related documentation.Dispositioned Raw Materials, components and vaccine drug substance/drug product.Shop floor support (Quality oversight, logbook review, solves issues real time with operations personnelReviewed stability dataAPR generation and approval.Generated investigations and approval of product complaints.SOP generation, review and/or approval.Supported the Rockville site and other cross- functional activities as needed.

• Application of cGMP, regulatory requirements, directives and guidelines from Genzyme Corporate Quality Management and/or from established regulatory agencies as pertaining to day-to-day (e.g. failure investigations, procedure clarification) and/or inspectional decision –making.• Support his/her counterpart in the Quality Systems function for management of inspectors from diverse regulatory agencies (e.g. EMA, MHRA, RP Darmstadt, ANVISA, FDA, TGA, etc.)• Compile/provide metrics in support of activities related to Quality System activities (including but not limited to Deviations, Investigations, CAPA, Change Control, Effectiveness Review, PPR, QMR, regulatory commitment closure) on a periodic and ad-hoc basis.• Provide risk facilitation services for 68/74/76 NYA site.• Identify data and vet data with Biostatistician (statistical analysis) to review significance of identified trends.• Write and revise SOPs and Quality Documents• Implement Corporate Standards and Policies• Coordinate the establishment of vendor/site and/or site/site Quality and Technical Agreements• Facilitate and coordinate compliance activities with the Site Quality Council and QSRT regarding industry trends and corporate initiatives.•Provides QA support for deviations, CAPAs, change controls, laboratory investigations at the facility.

• Performed qualifications in a cGMP biotech manufacturing facility, managed multiple complex qualification projects and provided technical assistance to less experienced team members.• Wrote, reviewed and approved qualification protocols and reports as well as executed these protocols. Resolved protocol discrepancies and deviations.• Evaluated new technologies for implementation in the QC Laboratories.• Ensured GMP compliance of all activities performed.• Represented QC Validation in internal and external audits as required.• Ensured appropriate facility support and provide technical expertise.• Reviewed standard operating procedures.• Maintained a positive relationship and network effectively across sites and organizations.• Provided project oversight and participate in cross-functional teams.• Practiced safe work habits and adhered to Genzyme’s safety procedures and guidelines.• Performed other additional job related duties as required.

• Investigates UV-Vis spectrophotometry assays, HPLC/GC/SDS-PAGE methods.• Troubleshoots and performs maintenance on complex laboratory equipment including HPLC and GC systems.• Investigates and troubleshoots Quality Control methods.• Reviews QC Data related to investigations and non-routine protocols (IQ, OQ, PQ, etc.,) for compliance to procedures and specifications. • Prepares statistical analysis of results.• Prepares investigations related to OOS/OOT results and develops CAPAs.• Participates in training of less experienced staff on new procedures.• Transfers methods from support groups to the QC laboratory.• Provides technical expertise during development of complex documentation for new and current procedures and technical reports.• Implements new technologies/instrumentation in the QC laboratory.• Routinely assumes a technical leadership role in the QC laboratory.• Assist with driving to root cause for deviations from QC methods and develop appropriate CAPAs.• Recommends method improvements.• Represents QC as a technical contact for laboratory projects.• Effectively works with others to achieve shared goals.• Interacts with internal and external personnel on technical matters requiring coordination between sites.• Works independently with minimal to no supervision and direction.• Works in compliance with cGMPs.

• Tracks and trends stability data, and provides quarterly updates at minimum.• Coordinates/Schedules Stability sample pulls and testing in the QC department.• Leads the implementation of SQL LIMS project, and participates in QC Lab expansion activities.• Leads the QC effort to ensure QC software systems are 21CFR Part 11 compliant. • Coaches/Trains others on SQL LIMS and 21CFR Part 11.• Writes all Stability Protocols and Reports.• Manages Sample, Stability, Reference Standard and Control Inventory. • Helps investigate, assess, and troubleshoot analytical and/or equipment problems.• Initiates and helps investigate all stability related discrepancies (i.e., deviations, OOT, OOS, etc.).• Maintains all Stability Project folders up to date.• Writes and revises SOPs, technical protocols, and reports as needed.• Participates in the acquisition, installation and qualification of new Equipment.

Performs general to complex release and stability testing for drug substance and drug product using HPLC, CE (CZE and CiEF), gel electrophoresis and other quality assays. Supports operational systems such as equipment procurement and maintenance, standard and reagent preparation, and forms control. Assists in the authorship, and execution of method qualifications and transfers. Authors SOP's, deviations and OOS investigations and MDNs. Troubleshoot routine problems related to laboratory procedures, assay performance, instrumentation, and data. Trains other analysts to perform various laboratory procedures and assays. Assists in the installation and qualification of instruments. Authors and executes OQ and PQ scripts for the implementation of a LIMS system.Aliquots samples for routine stability testing.

Performed lab testing using diversified wet and instrumental chemical analysis on raw materials, packing materials, finished products, stability and environmental samples. Operates and maintains sophisticated, computer-controlled instrumentation (HPLC, GC,UV-Vis and Karl Fisher) Used LIMS for data entry. Worked with other laboratory staff to revise SOP's. Trained other Chemists on new equipment and procedures.

Worked under the Senior Scientist making prototype capsules and tablets for clinical trials. Made detailed observations, analyzed and interpreted results, documented experiments and wrote experimental results, summaries and protocols.

Responsible for the analysis of liquid and solid dose products. Responsible for the performance of tests and analysis of raw materials, in-process and finished products.