DIANA HERRERA
Emeryville,CA
Summary
Pharmaceutical industry professional adept at managing time and resource allocation to facilitate timely project completion and operational activities. Adaptive and deadline-oriented with capacity to execute and complete multiple projects in high-stress environments. Extensive pharmaceutical and biotechnology experience in technology transfer, data integrity, process/method validation, process/method development, C&Q, process engineering, automation, High Through-put Screening and operations management.
Overview
20
20
years of professional experience
Work History
Senior Technical Manager/Senior Engineer 2
BioMarin Pharmaceutical Inc
05.2021 - Current
- Program Manager and Project lead for Commissioning & Qualification activities associated with capital project portfolio for development, Clinical and Commercial production: including: 1) Lead projects with C&Q scope for facility modifications and capital equipment procurement 2) Monitor progress of project milestones with Project Managers and functional leads 3) Ensure relevant validation/project documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements 4) Ensure that adequate communication plans are in place and delivered to ensure that all project stakeholders are informed and consulted on key project activities, progress, and decisions 5) Develop and maintain appropriate electronic and paper documentation & filing systems to ensure that all Commissioning & Qualification documents are filed during project execution and safely archived following project completion
- Support the development and maintenance for the overall program of all Commissioning and Qualification activities, including the commissioning program initiative to define engineering practices and compliance requirements, automation/mechanical/system specific testing, training curriculum for all C&Q staff, new business process for the C&Q function, development of Risk Assessments and Trace matrices within the overall process.
- Generating Request for Proposals for Capital Expense projects and leading the selection process for C&Q vendors in support of multi-million dollar projects.
- Supervise and manage C&Q vendors (17 reports), including onboarding/offboarding, and the creation and implementation of training curricula, SOW.
- Forecasting C&Q demand and soliciting new vendors to support both GxP and non-GxP projects to decrease cost and increase talent and efficiencies
- Collaborated with capital project delivery leaders to develop a workforce model, with named resources, estimated project rigor and overall portfolio optimization for execution of the entire CA portfolio.
Regional Operations Manager
AZZUR GROUP
05.2020 - 05.2021
- Responsible for managing routine operations of the San Francisco office, including resource management, contract management, service execution support (SME client support, budget tracking, timesheet, invoice approvals) and financial management support (account receivables monitoring, accounts payables
- Responsible for managing and developing 11 direct reports and maintaining billable utilization
- Responsible for supporting business development activities
- Primary point of contact for business interaction with all client account, providing account management, leadership, and direction
- Supported Director in setting strategic direction for the San Francisco office including short- and long-term goals
- Managed and maintained revenue and profitability, as defined annually
- Managed service execution support by providing subject matter expertise, overseeing employee productivity and quality, and providing hands on support.
Lead Process Engineer
MILTENYI BIOTEC, DELTA PROJECT MANAGEMENT
10.2019 - 05.2020
- Commissioning and Qualification of Equipment to support QC assay and Process Technology Transfer
- Led QC team in various capacities, including project schedule management, authoring documents (site VMP, SIAs, Risk Assessments and other qualification lifecycle documents), technical direction and assistance, deliverable progress tracking, report and appropriate escalation
- Resource allocation management, budget and scope determination
- Reviewed/Approved qualification lifecycle documents and activities such as: URS, SRS, FRS, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
Senior Process Engineer
BAYER HEALTHCARE, DELTA PROJECT MANAGEMENT
06.2018 - 10.2019
- Supported the Quality Control Raw Materials Chemistry laboratory in the technology transfer of analytical methods to a new QC building: including instrument qualification activities, compendial method transfer, and internal method validation
- Contributed technical expertise within a larger team with a focus on automated laboratory system qualification and Data Integrity
- Troubleshooted methods/assays and analytical instrumentation
- Improved existing internal methods to optimize efficiency and results
- Coordinated verification/validation activities and drafting method/instrument SOP's
- Investigated questionable test results, authored and closed all Deviations as needed
- Collaborated effectively with QA representatives to manage the initiation, investigation, and closure of deviation reports
- Performed Risk Assessments per existing SOPs to evaluate the potential impact of a process, method or procedure on a product
- Trained laboratory staff, leading cross training efforts across multiple QC labs, reviewed test records and approved results
- Managed action items and timelines, allocating available resources as needed, leading ad-hoc and regularly scheduled meetings, writing meetings minutes, negotiation with team members and stakeholders, and leading project activities to key milestones
- Supervised RM CHEM PM/CAL program in the new RM CHEM QC laboratory
- Coordinated and supervised vendor activities in the new RM CHEM QC laboratory.
Senior Process Engineer
BOEHRINGER INGELHEIM, ADVENT ENGINEERING
04.2018 - 06.2018
- Installation Qualification (IQ) and Operational Qualification (OQ) of Bio-Tek Automated Microplate Readers and WinKQCL software for WinKQCL lab workstations used for Limulus Amebocyte Lysate (LAL) testing
- Generated and revised qualification lifecycle documentation facilitated document review and approval of documents within established timelines while ensuring documents are technically accurate and consistent with established guidelines
Senior Process Engineer
BAYER HEALTHCARE
03.2017 - 04.2018
- Led validation activities in support of assay/process technology transfer to Germany, including analytical method Development/Validation for Blood Gas Analyzers (RapidLab248) and MAVF Planova Filters and other In-Process Controls
- Performed comparability studies of current method/process procedures to compendial guidelines
- Project Management responsibilities included: developing/tracking project schedule, identifying constraints, driving the resolution of items, tracking project completion/budget, and training of operators and engineers involved in validation activities.
Senior Process Engineer
BAYER HEALTHCARE
08.2016 - 04.2017
- Cleaning/Process Validation - Factor VIII (rFVIII-N): Authored cleaning and process validation protocols/reports for rFVIII-N purification activities through FFD (Filling and Freeze-drying).
Process Engineer
BAYER HEALTHCARE
03.2016 - 08.2016
- Periodic Review of clean utilities (WFI, CSG) and production equipment (Blast Freezers, Cell Bank Freezers, Biological Safety Cabinets, Media/Harvest Cold Rooms).
Senior Associate Scientist
AMYRIS, INC
05.2011 - 05.2015
- High-Throughput screening - Development and Operations Team: Developed, optimized, validated : and standardized seed vialing conditions for fermentation purposes: Improvements made in these areas reduced process time from 40 to 8 hours per cycle and led to a success rate of 85% over a previous success rate of 30%
- Developed a set of screening parameters that would predict the performance of strains during fermentation
- These parameters became the acceptance criteria for the quality control (QC) of strains during pre-fermentation stages
- Participated in the development of the fermentation seed train, optimizing growth conditions during its initial steps, leading to improved cellular growth and product formation
- Built a new model for analyzing sub-populations in seed vials and fermentation tanks
- Deployed this tool to screen for conditions where lower-producing mutant strains were less favored and implemented improved conditions in the pipeline
- Authored and implemented standard operating procedures (SOPs) for seed vialing operations, contamination tests, and other documentation related to research and development (R&D) and manufacturing operations
- Developed and optimized seed vialing conditions for optimal cellular growth pre- and post- freezing
- Process automation and data management: Collaborated with software engineers to automate data analysis and develop a live tracking system that allowed for fast data turnaround, increasing the efficiency of the process overall
- A robust database was developed in order to consolidate sample information gathered at various stages of the manufacturing process
- Manufacturing: Developed and optimized strain vialing and freezing conditions for optimal cellular growth for use in industrial fermentation, balancing process changes between representation of manufacturing conditions and physiological needs
- Harnessing the predictive power of microtiter plate models for multiple products in fermentation scale up: Developed a multivariate model that combines separate measures of strain performance taken in 96- well microtiter plates (MTPs) into a single metric that predicts strains' ability to produce product in bioreactors during the fermentation process
- Based on this process, a universal MTP culture model was developed to include a broad panel of molecules
- With this platform, the time to optimize new methods dedicated to novel molecules fell from 12-24 weeks to less than 6 weeks
- This efficiency in method development/optimization allowed resources to be allocated to novel measurements that may add more predictive power to the multivariate model and further increase MTP to tank correlation
- Collaborated with software engineers to develop protocols for high-throughput microbial strain engineering, plate models for microbe growth and production, and then enable their use in high throughput workflows
- Familiar with concepts in statistics and tools to analyze data (Excel, Spotfire, JMP, SQL)
- Experience using lab automation to enable high throughput protocols and proficient in the use of analytical equipment (Beckman, Qpix, Phoenix, plate readers, bar code systems, flow cytometry, Viaflo)
- Managed seed vialing operations: produced quality-controlled seed vials for use in Manufacturing and R&D.
Senior Researcher
Harvard Medical School
10.2006 - 09.2010
- Yuang Juang, PhD, MD:
- Involved in executing and troubleshooting research projects aimed at understanding immune cell signaling and gene transcription and identifying new therapeutic targets to treat inflammation in human SLE (Systemic lupus erythematosus)
- Vijay Kuchroo PhD Mohamed Oukka, PhD:
- Investigated the role of Th17 and gamma T cells during Multiple Sclerosis using the Experimental Autoimmune Encephalomyelitis (EAE) mouse model
- Hanspeter Waldner, PhD: Investigated the mechanisms that maintain tolerance or induce T cell responses to self-antigens, resulting in resistance or susceptibility to autoimmune disease
- Collaborated with the laboratory robotics team to develop and test a compound library to identify small molecule modulators of targets implicated in Multiple Sclerosis.
Undergraduate
Breast Cancer Research, Purdue University/Methodist Research Institute
09.2004 - 08.2006
- Investigated the mechanisms by which prolactin growth hormone and adiponectin regulate locally produced hormones, receptors and growth factors involved in mammary tumorigenesis
- Rafat Siddiqui, PhD: Investigated the synergistic modulation of breast cancer progression by combination of nutrients and drugs with omega-3 fatty acids, focusing on the effects of Omega-3 fatty acids and polyphenols on MDA-231 breast cancer cells.
Massachusetts Institute of Technology
05.2004 - 08.2004
- Howard Hughes Medical Institute Exrop scholarship recipient, HHMI Exrop
- Investigated the role of miRNAs in tumor progression and metastasis in a genetically engineered mouse model for human Non-small Cell Lung Cancer (NSCLC), specifically, identifying tumor suppressor genes on chromosome 3p21 involved in human lung cancer development.
Education
Bachelor of Science Neurobiology - Physiology And Biology
Purdue University
West Lafayette, IN01.2006
Bachelor of Science - Psychology
Purdue University
West Lafayette, IN05.2006
Skills
- Operations Management
- Portfolio Management
- Technology Transfer
- Process Validation
- Automation
- Data Integrity
- Manufacturing
- Quality Control
- Equipment Validation (IOPQ)
- Commissioning and Qualification
- Process Development
- Analytical Method Validation
- DOE (Design of Experiment)
Languages
Spanish
Native or Bilingual
Timeline
Senior Technical Manager/Senior Engineer 2
BioMarin Pharmaceutical Inc
05.2021 - Current
Regional Operations Manager
AZZUR GROUP
05.2020 - 05.2021
Lead Process Engineer
MILTENYI BIOTEC, DELTA PROJECT MANAGEMENT
10.2019 - 05.2020
Senior Process Engineer
BAYER HEALTHCARE, DELTA PROJECT MANAGEMENT
06.2018 - 10.2019
Senior Process Engineer
BOEHRINGER INGELHEIM, ADVENT ENGINEERING
04.2018 - 06.2018
Senior Process Engineer
BAYER HEALTHCARE
03.2017 - 04.2018
Senior Process Engineer
BAYER HEALTHCARE
08.2016 - 04.2017
Process Engineer
BAYER HEALTHCARE
03.2016 - 08.2016
Senior Associate Scientist
AMYRIS, INC
05.2011 - 05.2015
Senior Researcher
Harvard Medical School
10.2006 - 09.2010
Undergraduate
Breast Cancer Research, Purdue University/Methodist Research Institute
09.2004 - 08.2006
Massachusetts Institute of Technology
05.2004 - 08.2004
Bachelor of Science Neurobiology - Physiology And Biology
Purdue University
Bachelor of Science - Psychology
Purdue University
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