Anna-Lisa Thayer Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

• Perform analytical methods for cell based product in process, release and stability testing in GMP compliant laboratory.• Implement transfer, qualification and validation of analytical methods for cell based product testing.• Coordinate analytical testing strategy for incoming clinical programs in collaboration with Materials Management, Manufacturing, Quality Assurance, Facilities and Regulatory Affairs.• Support release and stability testing of master cell banks and working cell banks of AIRM products.• Track and test products according to stability protocols and test plans.• Manage Instrument Validation for QC equipment and ensure CFR compliance.• Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.• Preparation of reports and data packages for interactions between AIRM and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.• Develop, revise and review SOPs, qualification/validation protocols and reports.• Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.• Implement continuous improvements in the GMP Quality systems currently in place to ensure compliance with documented policies.• Participate in internal and external audits and ensure QC processes are in compliance.

• Routine use of MasterControl for document creation, revision, and training• Participate in technical investigations of process deviations to ensure production proceeds as scheduled • Routine operations in the manufacturing of the Company’s RPE product• Operate and ensure proper maintenance of BSC’s, microscopes, incubators, centrifuges, pH meters, and other manufacturing equipment• Perform aseptic technique including media preparation, media changes, cell passaging and harvests, and in-process testing• Complete required documentation and guide other operators on proper cGMP recording of entries and comments in batch records, forms, and protocols.• Initiate Document Change Requests; author, revise ,and review manufacturing documentation. • Assist in the completion of deviations and CAPAs of moderate complexity and scope.• Clean and maintain equipment for use in cGMP operations including the handling of CO2 and Liquid Nitrogen tanks and systems.• Work within the team and department in order to follow best practices and meet department goals.• Report any issues related to manufacturing performance, process and safety to management in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.• Assist in the training of new or junior staff on unit operations, cell culture, and procedures• Assisted with cross functional communications and scheduling to maintain deadlines for clean room installation• Contact outside vendors and complete purchase orders for materials and equipment• Oversaw and assisted with assembly of clean room fixtures and furniture

Littleton, Ma, Us

● Management of lab technician who was responsible for equipment, facility maintenance, and early stage client processing● Created schedules for clean room activities ● Dental pulp stem cell processing, culture, and analysis● Primary mesenchymal stem cell culture● Responsible for cell line expansions for third party● Follow GMP guidelines● Quality documentation monitoring and review● Train incoming employees in proper cell culture techniques including aseptic technique, BSC use, and protocols● Originate technical protocols and SOPs ● Review and edit SOPs, batch records and logs for accuracy and completeness● Assist with quality system - deviations, CAPAs, ● Responsible for coordinating with outside vendors for equipment calibration

Worcester, Ma, Us

● Customer service for Core laboratory services and products● DNA plasmid preparation and RNA extraction● Assisted with post-doc candidates’ experiments ● Prepared and maintained inventory for lab stock of competent cells ● Attended meetings on behalf of shRNAi Core

Worcester, Ma, Us

• Maintain multiple stem cell lines in culture.• Maintain batch records.• Perform gDNA extractions.• ICC• Embryoid body culture• Prepare samples to be shipped for external testing.• Write and revise SOP’s.

Structural Protein ChemistryAssist with studies focusing on various aspects of protein and oligonucleotide formulation development: ph/buffer screens, mechanical stress, shipping, administration Compile and report results in both written and oral format at group meetings and in monthly reportsPrepare therapeutic protein samples for small-scale lyophilization.Train other group members in performing routine procedures: circular dichroism, HIAC, Karl Fischer Coulometer, Coulter Counter, DLSAdditional laboratory skills: microscopy, buffer/solution prep, spectroscopy, lab notebook Various lab procedures: mock administration, lyophilization, determining minimal fill volume in vials and syringesAuthor and review of standard analytical procedures and technical memosAbility to work both independently and in a group setting

Data entry and maintenance of prescription orders, patient's health and insurance information files Knowledge of medication and medical terminologyExperience with ordering and maintaining appropriate inventoryExcellent communication skills Assist in training new employeesProficient with QS1 pharmacy software

Research & Development Functional GenomicsMaintained several lines of cancer cells for an extended period of time; both adherent and suspension typesAdditional laboratory skills: qPCR and PCR primer design, chromatin immunoprecipitation assays, Western blot, SDS-Page electrophoresis, cell culture, media preparation, cell lysis, formalin fixation of cells, antibody staining of cells, GLP techniques, aseptic technique, cell counting, protein assays, sterile filtration

Master'S Degree, Regulatory Affairs And Health Policy

Master'S Of Biotechnology, Biotechnology

Bachelor Of Science, Biotechnology; Bioinformatics

Pre-Pharmacy

High School Diploma