Michelle Stara
Lincoln,NE
Summary
Experienced Manufacturing, Science, and Technology (MSAT) representative with a proven track record of leading project workstreams and coordinating multi-functional activities to support commercial drug substance manufacture. Skilled in drafting technical documentation for commercial campaigns, implementing change management procedures, and collaborating with cross-functional partners to achieve team objectives. Specialized in risk assessments, control strategy management, continuous improvement, and change management throughout the product lifecycle. A Subject Matter Expert (SME) who partners with product development, manufacturing, quality, and regulatory teams to address complex deviations and ensure successful continuous improvements.
Overview
31
31
years of professional experience
Work History
MSAT Senior Scientist, Contractor
Lonza, Inc.
09.2020 - Current
- Program management for successful transfer into GMP production through process protocol writing, review, and collaboration with cross-functional teams and clients to ensure on-time execution of deliverables.
- MSAT Lead for Process Technology Transfer, reviewed client development and characterization reports, generated technology transfer and engineering run documents, performed Fit Gap analysis, Failure Modes and Effects Analysis (FMEA), Risk Assessments (RA), generated Process Flow diagrams, monitored process trends, and recommended process improvements.
- Technical Subject Matter Expert (SME), provided technical support to GMP execution of new processes, deviations, investigations, Corrective Action Prevention Plans (CAPAs), and change controls.
- Ensured process scalability and manufacturability and supported continued process verification activities.
- Supported regulatory submissions through helping maintain accurate dedicated equipment list and raw materials list (RML).
- Ensured continuity of production through working with supply chain and vendors to identify secondary source of critical materials. Completed technical review and drafted assessments of alternative materials to ensure fit for use.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Championed interdisciplinary collaboration across departments, fostering innovation and creative problem-solving among colleagues.
- Worked as member of integrated project team in highly collaborative work environment.
- Generated reports detailing findings and recommendations.
MS&T Senior Process Scientist
Huvepharma, Inc.
08.2024 - 01.2025
- Lead technical transfer activities for new products, ensuring compliance with quality standards.
- Collaborate with cross-functional teams to troubleshoot and resolve complex technical issues.
- Manage end-to-end process for product development, from pre-formulation to packaging closure.
- Ensure new equipment is installed according to standards and protocols. Lead and coordinate IOQ/PQ and validation processes as required.
- Lead process optimization activities to ensure manufacturing processes are robust and cost effective.
- Lead the cleaning validation strategy and responsible for cleaning validation activities.
- Lead the continuous improvement program related to process optimization.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
Technical Operations Principal Scientist, Contractor
Homology Medicines, Inc.
08.2022 - 08.2023
- Lead the technical review of all external process development and manufacturing documentation (including batch records, stability protocols/reports, tech transfer documents).
- Lead internal coordination and cross-functional alignment for external manufacturing activities, including technical investigations of anomalous results.
- Provided technical leadership to support product strategy and commercial product support.
- Assisted in developing process and capability for external manufacturing partner assessment and selection.
- Developed process and capability for technical transfers, scale-ups, and process assessments.
- Conducted document review, organization and quality control of data acquisition to draw relevant conclusions and direct activities.
QC Validation Lead, Contractor
ThermoFisher, Inc.
06.2021 - 08.2022
- Completed client User Requirement Specifications (URSs) for analytical-based operations equipment.
- Reviewed Technical and Functional Specifications to ensure equipment was correctly vetted.
- Partnered with Patheon to draft and review Commissioning Checklist and related protocols.
- Reviewed IOQ Protocols and provided specific feedback based on client use.
Upstream Process Technical Transfer Scientist, Contractor
Astra Zeneca
04.2021 - 07.2021
- Build and maintain relationships with partner groups internationally on cross-functional teams.
- Proactively addresses risks/issues and influence partners/CMOs to avoid non-conformances and enable efficient transfers.
- Author technical assessments and/or reports and deliver presentations.
- Participate in design and analysis of lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances.
R&D, Process Development Scientist, Contractor
Aldevron
04.2020 - 09.2020
- Worked with clients to support process redesign.
- Conducted design of experiments (DOEs) for optimization of existing processes in plasmid manufacturing.
- Reviewed process flow diagrams.
- Investigated and recommended process improvements.
Senior Validation Engineer, Contractor
AveXis
12.2019 - 05.2020
- Executed and managed medium-sized project plans.
- Developed validation plans using risk-based approaches (FMEA, PHA, etc.).
- Performed risk assessments to confirm safe and compliant designs and recommended additional controls as required.
- Reviewed project documentation (URS, Functional Requirement Specifications (FRS), Technical Specifications, Functional Specifications).
Upstream Development Associate, Contractor
AGC Biologics
12.2019 - 05.2020
- Managed large data sets and provided technical guidance to others in the analysis and interpretation of data.
- Drafted development protocols and characterization reports.
- Coordinated activities and experiments with project management, manufacturing, purification development, and analytical development.
- Followed-up on ongoing production campaigns including client communication, troubleshooting, handling of deviations and CAPA’s.
Director, Process Sciences, Biologics, Contractor
BioVectra Inc.
12.2018 - 12.2019
- Performed process scale-up and scale-down for CMO/CDMO clients.
- Technical transfer from process development into GMP manufacturing.
- Designed and managed the project for a temporary (6-9 month) process development lab facility on site within the Quality Control lab area.
- Designed and managed a permanent (3-5 years) process development lab facility at a separate location.
- Designed, procured (Syspro), installed, commissioned, and qualified new pharmaceutical processes and equipment for two new process development labs.
- Drove process, equipment, and engineering improvements and modifications to existing manufacturing equipment.
- Prepared and executed commissioning and qualification protocols (Master Control), startup of new process equipment and instrumentation.
- Actively participated in BioVectra’s quality systems, focusing on the cGMP aspects, production batch records, and operator training programs.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Improved project efficiency with strategic planning, resource allocation, and time management practices.
- Optimized staff performance by designing comprehensive training programs tailored to individual needs.
Lab Manager, Chemistry Teaching Labs
University of Nebraska
08.2015 - 06.2016
- Manage 3 direct full-time employees and 75 teaching assistants.
- Actively sought federal grants to expand chemistry teaching to underrepresented groups.
- Developed and implemented (GMP based) lab and safety policies that covered 100+ lab sections with ~2900 students.
- Established lab teaching assistant (TA) training program (Boot Camp) for new undergraduate and graduate lab TAs.
- Developed a chemical and supply inventory and equipment management system using a barcode system.
- Co-developed a new course entitled, 'Molecular Biotechnology: From Gene to Product'. A new lab course for undergraduate Chemical and Biomolecular Engineering students.
- Revised Chemistry Lab Manuals for introductory courses (CHEM 109, 110, and 113) to update experiments, outline and emphasize safety, and incorporate new experiments into the curriculum.
Senior Scientist
University of Nebraska
07.2014 - 07.2015
- Participated in contract negotiations with clients and established an excellent rapport with vendors/suppliers.
- Managed 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.
- Monitor and troubleshoot fermentation, engineering, and production runs within development laboratories and the GMP pilot plant.
Validation Scientist- Contractor
Novartis
07.2013 - 10.2013
- Led cleaning validation risk mitigation team, drafting validation risk assessments, protocols, reports, process deviations, non-conformances, and test scripts in response to FDA 483.
- 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 technical process deviations and non-conformances (OOS) using Six Sigma techniques.
- Contributed to successful audits by maintaining organized records of all validation activities and results.
Senior Associate Scientist
Pfizer
07.1994 - 05.2013
- Facility planning of cGMP Pilot Plant and Development Lab Remodel.
- Established Quality Systems for the cGMP Pilot Plant.
- Established a cGLP auditing program for the research labs.
- Directed 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.
- Managed transfer of antigens for further production in Europe and worldwide markets.
- Managed 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.
- Used creative problem solving to implement a comprehensive barcode labeling system enabling transfer of data to the Laboratory Information Management System (LIMS).
Education
PhD - Organizational Management
Capella University
MBA - Business
University of Phoenix
Graduate Studies - Biology/Biological Sciences
University of Nebraska-Lincoln
BA - Psychology, Biology
University of Nebraska-Lincoln
Skills
- Expertise in CMO/CDMO operations
- Biologics and Viral Vector experience
- Microbial fermentation techniques
- Scale-up and Scale-down process strategies
- Process development and optimization
- Technical Transfer
- Protocol development and report generation
- TrackWise, Veeva, Documentum, JMP proficiency
- Experience with SAP systems
- Experience with FDA regulations and EU compliance standards
- ICH and USP knowledge
- Commissioning, Qualification, and Validation experience
- Oversight of change control processes
- Investigative analysis and CAPA management
- Experienced with Six Sigma methodologies
Timeline
MS&T Senior Process Scientist
Huvepharma, Inc.
08.2024 - 01.2025
Technical Operations Principal Scientist, Contractor
Homology Medicines, Inc.
08.2022 - 08.2023
QC Validation Lead, Contractor
ThermoFisher, Inc.
06.2021 - 08.2022
Upstream Process Technical Transfer Scientist, Contractor
Astra Zeneca
04.2021 - 07.2021
MSAT Senior Scientist, Contractor
Lonza, Inc.
09.2020 - Current
R&D, Process Development Scientist, Contractor
Aldevron
04.2020 - 09.2020
Senior Validation Engineer, Contractor
AveXis
12.2019 - 05.2020
Upstream Development Associate, Contractor
AGC Biologics
12.2019 - 05.2020
Director, Process Sciences, Biologics, Contractor
BioVectra Inc.
12.2018 - 12.2019
Lab Manager, Chemistry Teaching Labs
University of Nebraska
08.2015 - 06.2016
Senior Scientist
University of Nebraska
07.2014 - 07.2015
Validation Scientist- Contractor
Novartis
07.2013 - 10.2013
Senior Associate Scientist
Pfizer
07.1994 - 05.2013
MBA - Business
University of Phoenix
Graduate Studies - Biology/Biological Sciences
University of Nebraska-Lincoln
BA - Psychology, Biology
University of Nebraska-Lincoln
PhD - Organizational Management
Capella University
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