Michelle Stara - Senior Scientist MSAT, Lonza

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Work Background

Homology Medicines, Inc.Senior Technical Consultant

Aug. 2022 - Aug. 2023Boston, Massachusetts, United States · Remote• Leads the technical review of all external process development and manufacturing documentation (including batch records, stability protocols/reports, tech transfer documents). • Leads internal coordination and cross functional alignment for external manufacturing activities, including technical investigations of anomalous results. • Provides technical leadership to support product technical strategy, regulatory strategy, and clinical/commercial product support. • Assists in developing process and capability for external manufacturing partner assessment and selection. • Develops process and capability for technical transfers, scale-ups, and process assessments. • Supports the Development Organization with supply vs demand modeling and business case support to internal technology assessments, capacity analyses, and investigation support.

LonzaMSAT Senior Scientist

Sep. 2020 - Mar. 2024Houston, Texas, United States · Hybrid• Responsible for the successful transfer of viral vector processes into GMP production. Collaborate with cross-functional teams, including clients, Process Development, Manufacturing, and Program Management to ensure deliverables are on-time. • Act as technical Subject Matter Expert (SME) within the MSAT group as well as for the various project teams. Provide technical support to GMP execution of the new processes and any deviation investigations, Corrective Action Prevention Plans (CAPAs), and necessary change controls. • Ensure process scalability and manufacturability and support process validation activities for late phase production. Provide guidance on process transfer and support activities. • Functional Lead for Process Technology Transfers. Perform detailed review of clients and Research and Development (R&D) process and generates, in collaboration with R&D, technology transfer documents. Performs Fit/Gap analysis and process Failure Modes and Effects Analysis (FMEA), author / review Process Flow Diagrams and Batch Records, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports. Recommends improvements for MSAT practices and procedures. • Supports root cause analysis for major process deviations. Support CAPA and change control processes • Management of data and analyzes of various operational parameters. • Technology transfer activities to include but not limited to, performing process fit-to-plant, equipment characterization and scale-up, Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Bill of Materials, review and approval of production Master Batch Records. • Author and review protocols, technical reports, technology transfer documents, SOPs, Master batch records, formulation records, and work instructions. • Review continual process validation reports to determine critical quality attribute and process parameter trends.

AldevronResearch Development Process Engineer

May. 2020 - Sep. 2020Fargo, North Dakota, United States* Work with clients to support process redesign. * Design of experiment for optimization of existing process in gene manufacturing. * Work with upstream WAVE bag growth, cell pellet freezing and resuspension, cell lysis, flocculation, filtration, TFF, chromatography, and formulation. * Draft protocols and final study reports. * Review process flow diagrams. * Investigate and recommend process improvements.

AveXis, Inc.Senior Validation Engineer

Jan. 2020 - May. 2020Longmont, Colorado, United States* Author or manage authoring of commissioning, qualification and validation plans, validation protocols, validation summary reports and requirement trace matrices. * Project execution plan development and management of small to medium size projects. * Validation using risk-based approaches (FMEA, PHA, etc.). * Perform risk assessments to confirm safe and compliant designs and recommend additional controls as required. * Review project documentation (URS, FRS, Technical Specifications, Functional Specifications). * Partner with Quality to ensure a quality and compliant manufacturing environment.

AGC BiologicsUpstream Development Scientist

Dec. 2019 - May. 2020Seattle, Washington, United States* Manage large data sets and provide technical guidance to others in the analysis and interpretation of data. * Write development protocols and characterization reports. * Coordinate activities and experiments with project management, manufacturing, purification development, and analytical development. * Follow-up on ongoing production campaigns including client communication, troubleshooting, handling of deviations and CAPA’s.

BioVectra Inc.Interim Technical Director, Process Sciences, Biologics

Dec. 2018 - Dec. 2019Windsor, Nova Scotia, Canada* Responsible for process, equipment, and engineering improvements and modifications to existing manufacturing equipment. * The design, procurement, installation, commissioning and qualification of new pharmaceutical processes and equipment for two new process development labs. * Troubleshooting process equipment (high cell density fermentation, down stream processing, and chromatography) to improve operation and efficiency. * Designing and procuring new process and utility equipment, conferring with vendors, and evaluating products according to quality standards. * Prioritizing and executing assigned project deliverables. * Preparing and executing commissioning and qualification protocols. * Startup of new process equipment and instrumentation. * Supervising the operation of associated scientific instrumentation (manual, electronic, pneumatic or computerized equipment) to monitor and optimize the processes related to media preparation, upstream process development, downstream process development, and analytical methods development. * Actively participate in BioVectra’s quality systems, focusing on the GLP/cGMP aspects, batch production batch records and operator training program.

Henningsen Foods Inc.QA/QC Manager

Sep. 2016 - May. 2018Omaha, NEResponsible for managing and coordinating the QA and QC operations at the corporate headquarters of Henningsen Foods in Omaha, NE reporting directly to the VP of Quality. Responsible for all QA and QC for Henningsen Foods collaborating with Production, Operations, Materials Management, Sales, Marketing, Technical Services, R&D, Accounting, and Human Resources. HACCP and Six Sigma Black Belt certified. • Qualified NIR (Near-Infrared Reflectance spectroscopy) against wet chemistry methods for moisture, fat, and protein content in dehydrated egg and meat products. • Collaborate with LabVantage to configure and install LIMS at three manufacturing sites as well as corporate testing and release lab. • Validated new test methodologies. • Provide the necessary resources (personnel, equipment, and supplies) for QA/QC to ensure confidence in lab results. • Maintain a safe working environment for laboratory personnel. • Monitor laboratory quality systems to ensure they meet or exceed internal and external standards. • Partner with Operations and Production to ensure the compliance of SQF 2 standards and move into SQF 3 and coordinating with internal and external partners to meet FSMA regulatory standards; performs internal and external audits and regulatory inspections. • Assists customers and staff in interpreting laboratory data and methods as well as providing technical expertise. • Perform data review, product Holds, Rework (Unpacked), and product Releases. • Develop and ensure new protocols and methodologies meet or exceed specifications. • Provide technical expertise, guidance, and instruction to ensure outstanding performances of the QA/QC staff. • Write SOP’s, create forms, HACCP plans, CAPA’s, Safety Plans, and Validation Plans. • Identify deficiencies and develop corrective active plans to address all deficiencies.

University of Nebraska–LincolnLab Manager for Chemistry Teaching Labs at the University of Nebraska

Aug. 2015 - Jun. 2016Chemistry DepartmentEstablished a vision for the chemistry teaching laboratories supported by goals and strategies. Using estimated enrollment and laboratory fees, developed an operational budget to include long and short term goals (disposables, equipment, and facilities). Utilized available facilities to strategically schedule courses based upon enrollment, availability, and anticipated interest in specific courses. Worked with the department chair and vice chair to determine the best utilization of space and the feasibility and timing of future lab remodeling. Actively seek federal grants to expand chemistry teaching to underrepresented groups. Develop and implement lab and safety policies that cover 100+ lab sections with ~2900 students. Establish lab teaching assistant (TA) training program (TA Boot Camp) for new undergraduate and graduate lab TAs. Manage ~75 lab TAs per semester, two stockroom workers, and an administrative assistant. Design, execute, modify, and evaluate the chemistry lab program with professors to establish a leading Big 10 curriculum. Develop laboratory experiments and prepare demonstrations as integrated with curriculum. Supervise, participate, organize, and evaluate all aspects of the teaching chemistry laboratories. Daily Responsibilities & Notable Contributions: • Develop a chemical and supply inventory and equipment management system using a barcode system. • Establish a system and monitor the usage rate of lab chemicals and consumables. • Establish a routine maintenance schedule for lab equipment and repair. • Manage ~60 undergraduate and graduate level TAs per semester. • Organize chemistry labs for ~2200 students per semester. Prepare lab manuals; maintain laboratory rooms, supplies, and equipment. Devise the exam seating charts and organize and manage the exam grading of ~1700 exams by TAs during a three hour grading session.

University of Nebraska–LincolnScientist 2

Jul. 2014 - Jul. 2015Othmer HallManaged fermentation scale-up team (seed flask to 200L fermentation vessel) and related optimization activities (i.e. linear and exponential feed rates including temperatures, pH range and fine-tuning) of genetically modified yeast and bacterial strains related to the production of therapeutic proteins for use in Phase I and II clinical trials. Provided subject matter expertise in correspondence with regulatory agencies (FDA and client lab regulatory and quality groups). Participated in contract negotiations with clients and established an excellent rapport with vendors/suppliers. Daily Responsibilities & Notable Contributions: • Supervise up to two student researchers while ensuring compliance with standard operating procedures (SOPs) and safety/regulatory requirements. • Monitor and troubleshoot fermentation, engineering and production runs within development laboratories and the GMP pilot plant; conduct relevant literature searches, draft technical reports and present findings to peers. • Teach “Molecular Biotechnology: From Gene to Product” lab course to undergraduate Chemical and Biomolecular Engineering students.

Bell PDCScientist- Contractor

Jan. 2014 - Jul. 2014Pleasant Dale, NEManaged development lab by conducting lab-scale experiments to determine feasibility of cell removal, concentration and/or diafiltration processes using cross-flow filtration platforms. Ensured compliance with FDA-regulated standards in addition to determining optimal sheer rate, trans-membrane pressure (TMP), temperature and membrane scouting based on research literature and white papers. Used experimental design and data analysis to monitor and evaluate process runs.

NovartisValidation Scientist- Contractor

Jul. 2013 - Oct. 2013Lincoln, nebraskaLead cleaning validation risk mitigation team on the Sentinel product line. Proficient in the drafting of validation risk assessments, validation protocols, validation reports, process deviations, non-conformances, and test scripts to support the manufacture of Sentinel, Excedrin and Thera-Flu. Conducted technical review of completed documents, protocols, Corrective and Preventative Actions (CAPA) and interim/final reports. Collaborated with Quality Assurance to ensure accuracy and compliance with FDA regulations; investigated process deviations and non-conformances using Six Sigma techniques. Daily Responsibilities & Notable Contributions: • Conducted technical review of completed documents, protocols, Corrective and Preventative Actions (CAPA) and interim/final reports. • Collaborated with Quality Assurance to ensure accuracy and compliance with FDA regulations; investigated process deviations and non-conformances using Six Sigma techniques.

PfizerScientist

Jul. 1994 - May. 2013Lincoln, Nebraska AreaDirected early and late stage biological process development of bacterial antigens using design of experiment and statistical analysis of data. Developed a robust manufacturing process through initial development and continued process optimization. Developed in-house quality testing methods to ensure compliance with regulatory standards. Managed the transfer of antigens and related documentation for further production in Europe and worldwide markets. Implemented cross-functional, multi-site product development team to support internal technological improvements (i.e. real-time recording of data); established development timelines and budget forecasting based upon potency of experimental lots and personnel/equipment needs. Collaborated with third party IT company to write and validate computer software program that computed turbidimetric assay results. Using creative problem solving, implemented a comprehensive barcode labelling system enabling expeditious implementation/transfer of data to the Laboratory Information Management System (LIMS). Managed summer internship programs and projects, providing mentorship and coaching to students throughout the execution of research and quality control projects.