Prior to joining Biologics Consulting, Chris served as Global Director, Discovery Sciences, at Innovimmune Biotherapeutics, where he managed development of a portfolio of pre-IND drug candidates. She has also been a facilitator/teacher at both the high school and university levels and has a passion for music and singing. Her expertise lies in informed consent and clinical research project management. A superalloy, or high-performance alloy, is an alloy with the ability to operate at a high fraction of its melting point. Adrienne Serrao is an Intercultural Coach and Trainer, bringing over 20 years of experience working with senior leaders. for the Protection and Security of the Citizen, Monitoring Agriculture with Maune, D.F. In 2012, he was appointed Course Director at CPA, CGA for Advanced Corporate Finance and Management Auditing. She worked previously for the Certified General Accountants of Ontario. Currently, Rene is the Vice Chair of Hamiltons Rental Housing Sub Committee, the President of the Board of Directors of Wellwood, a local cancer resource centre, the former chair of the Arts Advisory Commission for the City of Hamilton and a past member of the Cultural Policy Roundtable for the City of Hamilton. Animal study and clinical trial development to achieve regulatory success He has provided online training to thousands of people across the world teaching about security and privacy. She holds a joint Honours Bachelor of Arts in History and Ancient Greek and Roman Studies and graduated from Fleming College Health Information Management Program in 2014. She authored Module 3 submissions for two BLAs and developed responses to FDA Information Requests. The probability for an individual pre-existing fracture to satisfy MohrCoulomb fracture slippage criterion equals to the probability of the prevailing gradient of fluid pressure change (p/h) being greater than the fracture criticality. 5b, c), they were relatively active over the remaining period (Fig. Additionally, Becky led the internal audit program and regularly assisted in third party audits. Paul Chipperton is the CEO of CanFocus Technologies Inc. and the Managing Director of EiGR Consulting. In 1999, Mr. Fraser departed Humber College to launch the Golf Management Institute of Canada (GMIC), and the PGM program at Niagara College in 2000. As a leading surety specialist, Brian is well known by the largest surety companies and underwriters in the North American surety marketplace. 9b) and regional fracture density related to neighbouring major faults (Fig. Int J Coal Geol 232:103627, Cao W, Durucan S, Cai W et al (2020b) The role of mining intensity and pre-existing fracture attributes on spatial, temporal and magnitude characteristics of microseismicity in longwall coal mining. She enjoys mentoring emerging therapists and provides clinical supervision for graduate students throughout their internships and beyond. Her experience includes resume development, interview preparation, networking, career advising, instructing and mentoring students. Donna-Bea began her career at the FDA in 1994 as a reviewer in the Ob/Gyn devices branch, and entered management as the Branch Chief for Pacing and Electrophysiology Devices. Glenn Skrubbeltrang is a Certified Professional Accountant (CPA) and a university lecturer. In addition, she has an advanced certification in Regulatory Affairs and pursuing her masters in Regulatory Science from San Diego State University. The concentration of carbon dioxide (CO 2) in the atmosphere has increased from approximately 277 parts per million (ppm) in 1750 (Joos and Spahni, 2008), the beginning of the industrial era, to 412.4 0.1 ppm in 2020 (Dlugokencky and Tans, 2022; Fig. Frost has over 13 years experience in adult higher education and over 20 years experience in business communications. In this role, she also gained experience assembling and validating eCTD submissions for the EMA as well as the CTA and FDA. BA, English, University of Akron, Akron, OH (1985). In this respect, recorded seismic events were not accurately correlated with prevailing fluid pressure changes that drive the seismic occurrence, which could lead to errors in estimating the critical fluid pressure. Her prior positions include working as President and CEO of StoreImage Programs Inc. and as the North American Divisional CFO of John Crane Automotive. He holds a Bachelor of Business Administration from the University of New Brunswick, a Master of Business Administration and has earned the Chartered Professional Accountant (CPA), Certified Management Accountant (CMA) and Chartered Marketer (CM) designations. In practice, it is noted that similar to the range of rock criticality (Shapiro 2015), the range of fracture criticality obtained may be influenced by the extent of fluid pressure increase at locations of induced seismicity. She holds a Business Administration Diploma from Mohawk College, as well as Certificates in Industrial Relations and Human Resources Management. In the past, he has been involved in teaching and instructionofboth graduate and undergraduate courses, as well as designing and evaluating courses and programs at McMaster University. Van Vu has been a McMaster University Continuing Education instructor since 2010. You will need to login before you can apply for a job. Dr. Minna Allarakhia is faculty at the University of Waterloo and Founder of Engaged Thinking Associates. Jonathan holds an MBA in Management Analytics, is a Project Management Professional PMP, and a Certified Business Analysis Professional CBAP. He started as a staff member working at a university doing application development. In the analytical arena, Christinas areas of expertise have included analytical method development and validation, development of reference standards and other critical reagents, stability strategy and evaluation, and establishment of comparability and/or similarity. He established GLP testing laboratories at Biogen, including laboratory design, equipment sourcing and validation, supporting antibody and PK/PD testing for various GLP/GCP studies. She has managed and consulted to organizations in Canada, the U.S., and the U.K. in the technology, aviation, insurance, health care, government, banking, telecommunications, manufacturing, energy and utility industries. For over 25 years, Mr. Fraser has taught hundreds of golf management students the business of golf. She has previously held teaching-assistant and lecturer roles for university accounting courses. 2022). Therapeutic areas include: treatment of anemia due to surgery, trauma, chemotherapy, emergency research under exception to informed consent (21 CFR 50.24) including in/pre-hospital resuscitation from hemorrhagic shock due to trauma. Key technical experience includes potency assays, release and characterization assays, stability, specifications, raw materials, and all associated quality documentation. He is an active member of the Board of Trustees for the London Waldorf School, an independent school in the heart of London with a unique pedagogy. IPCC. Browse our listings to find jobs in Germany for expats, including jobs for English speakers or those in your native language. Following a bumpy launch week that saw frequent server trouble and bloated player queues, Blizzard has announced that over 25 million Overwatch 2 players have logged on in its first 10 days. With this unique and specialized combination, Lesley works with individuals and teams to identify strengths and development areas, to elevate results, fuel positivity and foster engagement. Her product experience includes vaccines, insulin analogs, cytokines, monoclonal antibodies, and other therapeutic proteins. Vidhi also received aMasters of Science in Experimental Surgery from McGill University and her Bachelor of Health Sciences (Honours) at McMaster University. This includes healthy eating, physical activity, sleep, and breastfeeding. GCP Applied Technologies Inc., 2325 Lakeview Parkway, Suite 450, Alpharetta, GA 30009, USA GCP Canada, Inc., 294 Clements Road, West, Ajax, Ontario, Canada L1S 3C6 This document is only current as of the last updated date stated below and is valid only for use in the United States. Gordana works as a research associate at the University of Toronto and a lecturer in the Engineering faculty at McMaster University. Mr. Kutner has extensive experience in industrial scale production for cell and gene therapy. degree in Bioinformatics from Jonhs Hopkins in 2019 where he studied genomic databases and how to process and parse them using various software and command-line tools such as Python, Java, and SQL. Peter MacDonaldis an Employment Development Consultant for the City of Hamilton, Department of Emergency and Community Services. Passionate about making clinical trial participation available to all Canadians, Anthony has been an advocate for rural centres to have access to new medicines, thereby extending the geographic range of the idea research site. John received his MBA and Bachelor of Kinesiology from McMaster University, and is a Chartered Professional Accountant (CPA) and Certified Managerial Accountant (CMA). Mary Megali (Ph.D, MBA) has led the design, development, and execution of strategic HR projects for Top 50 Employers in healthcare, telecom, and commercial real estate. She then returned to ODE where she served as the deputy office director from 2008 2010 and the director of ODE from 2010-2014. Calley holds a BS in Biomedical and Electrical Engineering from Vanderbilt University. It is noted that this criterion is different from the MohrCoulomb failure criterion for intact rocks, where the most vulnerable orientation to rupture makes an angle of (45/2) with the maximum principal stress orientation, being the friction angle. He has held positions with Bunge Canada and Canadian National Railway and provided consulting services to Canadian Pacific Railway, McMaster University and Audit Services Canada prior to joining the Internal Audit department at McMaster. During his tenure, he was a principal force in bringing nine, small and large molecule products through development to commercial success. Each seismic event within 200m distance to the major faults was assigned to the closest fault. She has taught atthe CCE since 2003. Beyond coast-to-coast deliveries in Canada, he has also conducted training in Washington DC and New York City as well as in England and most recently the Philippines. She is experienced in publishing CRFs and submission documents. Lisa Orr is a nationally recognized etiquette expert and entrepreneur. Shannon has a Bachelor of Business Administration from Wilfrid Laurier University and has obtained her Fellow Chartered Insurance Professional (FCIP) and Canadian Risk Management Diploma (CRM). University of Iceland (Masters thesis), Blcher G, Cacace M, Jacquey AB et al (2018) Evaluating micro-seismic events triggered by reservoir operations at the geothermal site of Gro Schnebeck (Germany). She is currently working towards her PhD in Work and Organizational Studies at the University of Sydney Business School, with a focus on the platform economy, gender roles and gender equality. Her work has culminated in several publications in peer-reviewed journals and book chapters. No: ADVA 140 (M) A, F: Polycarboxylate: 12 (2020) 13: Less: 0.23: 2 to 20 fluid ounces per 100 lbs: 7/13/2026: ADVA 190: A, F: Polycarboxylate: 5 (2019) 15: More (0.1) 3 to 15 fluid ounces per 100 lbs: Scott holds a BBA from the University of Western Ontario in addition to several computer certifications, which have served to enhance students learning. Popular former unicorns include Airbnb, Facebook and Google.Variants include a decacorn, valued at over $10 billion, and a hectocorn, valued at over $100 billion. In that lab, he developed and applied a variety of animal models relating to angiogenesis and breast/prostate cancer bone metastasis. Hamilton holds a Bachelor of Sciences and Health Studies degree, a Masters in Public Health, and is a certified Project Management Professional (PMP). was the Interim Executive Director for the past year, and the Manager of Training and Community Engagement for Hamilton Centre for Civic Inclusion for 6 years. Joseph has 33 jobs listed on their profile. Jodi Travers is a Human Resources Professional currently working as a Labour Relations Manager for the Electrical Contractors Association of Ontario (ECAO). A visionary HR transformational leader, with high energy and high EQ, she embraces the challenge of transforming organizations and leading new, innovative human capital initiatives to gain competitive advantage. Collars for the five re-injection wells are projected to the plan view, Half-year fluid injection-induced seismicity occurrence probability forecasts based on statistics of fracture criticality in the 3D model domain at the Hsmli area (October 2020April 2021, AprilOctober 2021, October 2021April 2022, and April 2022October 2022). He teaches courses on intercultural communication, social transformation, gender issues, and the transformation of work at the University of Guelph-Humber. Dr. Megali holds a PhD, an MBA, Six Sigma Black Belt certification, and is an active member of the Human Resources Professional Association (HRPA). Julija is also an Assistant Clinical Professor (Adjunct) with the Department of Family Medicine at McMaster University. Dr. Carmen Dima is a professor with teaching responsibilities in the Accounting and International Trade Programs at diploma, undergraduate and post-graduate levels. Re-injection of the geothermal brine and condensate takes places in two distinct sites. Gillian is passionate about all aspects of health information and enjoys sharing that passion and knowledge with her students. She comes with both a patient and sponsor centric understanding of clinical research and has had the opportunity to lead data analysis and research design of dozens of research projects simultaneously. Additionally, Lesley is one of few Leadership Development Master Practitioners with the expertise to administer, assess and train the Energy Leadership Index (ELI) and the Emotional Intelligence Assessment (EQi-2.0) both recognized by Forbes in their top 3 assessments for professionals and leaders. These sponsors included Kodak, ATT, IBM, For over 30 years, Keith has worked with some of the worlds best-known companies to help them grow their sales. As a consultant he has been engaged by private and public owners for projects such as Confederation Bridge, Route 1 Gateway (New Brunswick). Eleanor enjoys teaching technical topics and has been known to inject literary references to Catcher in the Rye in her classes. He has taught in-class and online courses at McMaster for the last 6 years. Her work experience of 25 years has ranged from industries of distribution for lighting and decorative surfaces, to manufacture of transport vehicles and housing in both corporate and family-owned settings. Manufacturer: GCP Applied Technologies, Inc. Owais brings a blend of both industry and academia. To learn more, visit www.modernatx.com. The authors also wish to thank the Swiss Seismological Service (SED) at ETH Zurich for their permission to use the Hengill (Iceland) seismic monitoring data from the COSEISMIQ network (http://networks.seismo.ethz.ch/en/networks/2c/). According to the analysis carried out on 80 samples of basaltic hyaloclastic tuffs (Frolova et al. Owing to quasi-steady-state fluid flow conditions reached at the Hsmli area, the spatial distribution of fluid injection-induced pressure change is maintained almost constant over the period of investigation. View Joseph H.s profile on LinkedIn, the worlds largest professional community. She holds a B.A.A from Ryerson University, and B.Ed from Niagara University and AQ Qualification from Queens University for Communication Technology. He has worked in a number of different sectors including finance, energy, real estate, and government. In her spare time, you can find her with a camera in hand or with her hiking shoes on. She has been involved in the development and execution of CMC/Regulatory strategy for both novel and biosimilar products. Through various projects within the biotechnology industry she has expanded her formulation development experience to include therapeutic proteins (including monoclonal antibodies), both liquid and lyophilized, for both traditional and non-traditional delivery systems. She co-chaired the new Best Practice Guideline (BPG), A Proactive Approach to Bladder and Bowel Management in Adults, due to be released Fall 2020. For the last couple of years Caroline has been teaching aspiring HR professionals and sharing what the real world of HR is like and how to apply what you learn into a successful HR Career. The relative contribution of the hydrological and thermal effects depends on the distance from seismicity to injection wells and the injection duration. Jonathan is recognized for his engaging teaching style. His role is to develop products suitable for these organizations, especially for the fast-emerging programmatic field. The integrated interpretation of fracture criticality was performed for each fault zone, and was used to provide probabilistic injection-induced seismic hazard maps for the next half-year period at the site. Mr. Seiler comes to us with over 35 years of FDA review experience in medical devices. As a complement to her strong clinical education, Stephanie has incorporated additional evidence-based holistic certificates to further round out her training, including certifications in four mindfulness and meditation clinical modalities. He has been an administrator, vice-president of operations and owner of long-term-care and retirement communities and is now an adviser to the retirement home industry as a consultant. Macroaxis is a sophisticated yet simple to use personalized wealth optimization service that delivers measurable value in the form of improved return on investment portfolios of self-guided and socially-responsible investors. Prior to Hikma, he worked for IDEXX laboratories as an assistant lab technician in order to analyze and process samples from veterinarian clinics for the existence of parasites and harmful bacteria. Jennifer has worked closely with many of the stakeholders in the medical device arena: clinicians, FDA, academic, and industry. PhD, Chemical Engineering, Rice University, Houston, TX (1986), BA, Chemistry (Biochemistry emphasis), University of California, San Diego, CA (1977). Hydrogeological modelling targets the first property by representing the deterministic physical process from a mechanics perspective, which forms the basis for physics-based seismic evaluation methods (Zhang et al. With a degree in Humanities from McMaster, an MBA from the Schulich School of Business and almost 20 years of experience in corporate training, adult education design and business intelligence, he works with companies to turn data into information and builds tools to give them insight into their organization and industry. supportive housing since 2001. As Director of Quality Technical Systems at Biogen, Vince was responsible for cGMP oversight of corporate IT systems and automation as well as the strategic direction of the IT platforms used to support the Global Quality organization (LIMS, Training management, Deviation/CAPA/Change control management, Product Complaints and Document management. He is an instructor in the Schulich Executive Education Centre and has held teaching appointments at the University of Toronto, Wilfrid Laurier University, and Ryerson University. Mark has a Black Belt in Six Sigma as well as an MBA from the Schulich School of Business. She was instrumental in the development and implementation of the 510(k) plan of action, implementation of new legislation such as FDASIA and user fee negotiations within industry. He has a Bachelor of Applied Science in Computer Software Engineering, a Masters of Software Engineering and an MBA from McMaster University. Prior to GSK, Ji-Hyun worked for Pfizer as a Senior Associate Scientist. The fracture criticality concept proposed in this work complements conventional metrics in quantifying fracture slip susceptibility of injection sites. Rene is an excellent facilitator and leader in strategic planning and policy development, community development, evaluation and collaborative partnership development. In these roles, she was responsible for cultivating and delivering innovative programs to build succession, employee satisfaction, expansion and business growth. When not at work, Ben can be found spending time with his family and seeking adventure. "Sinc Rene Wetselaar is a two time graduate of McMaster University. Both critical fluid pressure change and fracture criticality are higher for induced seismicity close to the injection wells and lower for those away from the wells. According to field injection rate and pressure time series (Fig. These sponsors included Kodak, ATT, IBM, In addition to his Human Resources experience Stephen is an ICF accredited Career and Executive Coach, and owns his own company, Competitive Edge Coaching, based in Burlington. He practiced in a variety of areas including Corporate and Small Business Law; Real Estate Law; Estate Law; Employment Law; Administrative Law; Tort Law; Small Claims Court Law; Criminal Law and; Family Law. Cambridge University Press. A gifted consultant, facilitator and trainer, Linda has a unique ability to help organizations align their HR policies and practices with their mission, vision and core values, and to support these efforts through the implementation of current best practices. James holds a Bachelor of Arts degree from the University of Akron. When the overpressure is the dominant seismicity triggering mechanism, fracture criticality is related to the critical Coulomb failure stress change by \(\frac{\Delta {p}_{\text{c}}}{h}=\frac{\Delta {\text{CFS}}_{\text{c}}}{fh}\). Combining the fracture density obtained in Step 1, the likelihood of seismic event occurrence within each gridblock throughout the model domain for the next period is estimated according to Eq. He is currently the Director of Systems and Process Improvement in the Registrars Office at NAIT. Lisa has been teaching at McMaster since 2017. 2020a, b); and (4) pre-existing fractures do not mutually interact. Natural gas (also called fossil gas or simply gas) is a naturally occurring mixture of gaseous hydrocarbons consisting primarily of methane in addition to various smaller amounts of other higher alkanes.Usually low levels of trace gases like carbon dioxide, nitrogen, hydrogen sulfide, and helium are also present. Calley served as a Consultant / Senior Consultant on the Medical Device Team for 12 years. Dr. Iris M. Balodisis an Assistant Professor in the Department of Psychiatry and Behavioural Neurosciences at McMaster University and a faculty associate with the Michael G. DeGroote Centre for Medicinal Cannabis Research. Nat Commun 9:110, Lim H, Deng K, Kim YH et al (2020) The 2017 Mw 5.5 Pohang earthquake, South Korea, and poroelastic stress changes associated with fluid injection. Royal and Athabasca Universities. Add in a culture that truly values employees, combined with strong leadership, and you will have an organization poised for great success. Prior to joining Biologics Consulting, she was the sole US Regulatory Affairs representative for an Australian-based biotech startup and held regulatory affairs positions in both small and mid-size companies. With almost a decade of professional experience, Dr. Ahmad possesses a solid pharmaceutical background as a registered pharmacist, with a Doctorate of Pharmacy from the University of Florida. The reservoir model constructed was based on a geological model of the Hellisheii geothermal field, which incorporated surface mapping data, well data, well logging data, geophysics data, and laboratory analyses data (Gunnarsdttir and Poux 2016). During her time in operations, she provided trial management leadership and oversight over cross-functional teams in a projectized matrix environment. Her experience includes working on mergers and acquisitions, divestitures, leading business cases and various investment opportunities in the healthcare and retail space. David comes to Biologics Consulting with over 3 years of regulatory submission experience. It is noteworthy that pc, pc and CFSc generally increase with the reservoir depth, as such they may vary markedly across the depth range of field monitored seismicity (Fang et al. Konrad holds a MBA from the University of Liverpool. Carol Tristani is a Chartered Professional Accountant (CPA) and a Professor at a leading Ontario community college. As the account manager, Becky was the liaison between the regulatory and quality departments and the IT department. He also holds CFA (CharteredFinancial Analyst) and FRM (Financial Risk Manager) designations and is an active member of the local CFA society. 2015; Rahman et al. Skye is currently employed with the Saskatchewan Health Authority as a Certified Health Information Management Practitioner working in Acute Care and Mental Health. She is well-versed in eCTD guidance documents and was responsible for interpreting FDA and ICH specifications to produce business user requirements for the development of home-grown publishing software. She was responsible for developing a Supply Chain Risk Management program, which monitored the risks and mitigation strategies for the commercial supply chains, many involving Contract Manufacturing Organizations around the world. Pat is gathering materials to publish her next book on Using Inclusion Strategies to Engage Diverse Communities.. Christy began her career at the FDA in 1996 as a reviewer in the anesthesiology and defibrillator devices branch in the Office of Device Evaluation (ODE) where she also began serving as an FDA representative on several voluntary consensus standards for medical devices. He has extensive facilitation experience teaching software applications and training at Fanshawe, Brock, Michener Institute, and in the corporate setting. For the past 11 years she has been a career and life transition coach both privately and for Felix Global Corp. supporting clients at all levels including executive. Holli provides clients with regulatory project management and submission support for a variety of CBER and CDER regulated products. Lead Edge 29:304309, Shen LW, Schmitt DR, Schultz R (2019) Frictional stabilities on induced earthquake fault planes at Fox Creek, Alberta: a pore fluid pressure dilemma. She holds a BA from the University of Western Ontario, Certification in Adult Education, Public Relations and numerous assessment tools. As a research scientist, she has worked on projects for Ontario Hydro Technologies, Manufacturing Research Institute (MMRI), McMaster University, University of Toronto, Dofasco, Stelco, Dana, GM. Both indices are suitable to evaluate susceptibility to seismicity induced by a broad range of triggering mechanisms, such as rising fluid pressure (Talwani and Acree 1985; Elsworth et al. Ms. Patki has held various roles in clinical research management and has worked extensively on Phase II/III/IV industry sponsored clinical trials as well as Investigator Initiated clinical trials. Previously, he spent over 30 years in the banking industry working with a major national bank. Nancy has worked in various parts of Canada for over 20 years in a variety of business sectors, including legal, pharmaceutical, technology, and education. Julianne Jones has close to 15 years of professional experience in business and information technology management, program and project management development and delivery. 12b) are in general consistent with those of the seismogenic index (Fig. Nanda has co-authored numerous scientific publications and is frequently an invited speaker at Industry Meetings. Following a bumpy launch week that saw frequent server trouble and bloated player queues, Blizzard has announced that over 25 million Overwatch 2 players have logged on in its first 10 days. She facilitates training on behalf of the IIA North America to audit professionals globally. In: Induced Seismicity. Dr. Grace lead the BLA, sBLA, and MAA Module 3 analytical sections authoring, compilation and review activities, and was responsible for pre- and post-approval world-wide RHA interactions for Orencia, Nulojix and Yervoy. MS, Biotechnology & Regulatory Affairs, Johns Hopkins University, Baltimore, MD (2007), BS, Biotechnology, James Madison Universitys College of Integrated Science and Technology, Harrisonburg, VA (2001), Regulatory Affairs Certification (RAC) (2010). She is currently Faculty at the University of California at Berkeley, School of Public Health, in the Division of Biostatistics and teaches Biostatistics in the masters in public program. Mark is a Certified Business Intelligence Professional (CBIP) at the mastery level and maintains his professional focus at the intersection of business, operations, and technology. Sources of deviations in history matching for other wells include heterogeneous distribution of porosity and permeability, and fluid injection and thermal contraction-induced permeability change, which were not explicitly modelled in this work. Issued March 30, 2021 62 Whittemore Avenue Cambridge, MA 02140 (617) 876-1400 www.gcpat.com Manufacturing Plants: Bedford Park, IL Evanston, IL Mt. He has worked in Quality, Metallurgy and Customer Service in the Steel Making, Hot Rolling, Cold Rolling, Galvanizing, Shipping and Commercial areas. Global Compliance for Regulatory Inspections Mark has personally trained hundreds of managers from dozens of different industries. Furthermore, Becky was an account manager for division-wide regulatory affairs and quality (RA/QA) projects. She has also served as a regulatory project manager for Biologics Consulting clients, which involves coordinating the preparation of regulatory submissions and serving as the point of contact with FDA Regulatory Project Managers. Adam Prokop has taught and developed accounting, finance, general business, and operations courses at several Canadian universities. Prior to this, Irameet was working as Associate Professor with various Management Institutes in India for 6 years. ]7Liu Jeff is currently employed at The Institute for Better Health at Trillium Health Partners where he works to promote the safety, welfare, and rights of research participants. Paulines early career was sponsored by British Heart Foundation and Wellcome Trust initiatives. Previously she worked for the municipal sector in various human resource management roles. Donna is a member of the Association of Clinical Research Professionals (ACRP) and received certification as a Clinical Research Professional with the Society of Clinical Research Associates (SoCRA). Recently, she was an Electronic Publishing Specialist at PPD. He is also completing a graduate diploma in Gender Studies and Feminist Research. In addition, Ms. Smaldore attended many FDA meetings, performed literature searches, assisted in writing and QC of nonclinical 2.6 sections and regulatory documents (briefing documents, IBs, annual reports, FDA waivers, regulatory strategy memos and position papers). No: ADVA 140 (M) A, F: Polycarboxylate: 12 (2020) 13: Less: 0.23: 2 to 20 fluid ounces per 100 lbs: 7/13/2026: ADVA 190: A, F: Polycarboxylate: 5 (2019) 15: More (0.1) 3 to 15 fluid ounces per 100 lbs: Agent Representative for foreign groups as well as a primary regulatory contact for U.S. based companies. PADE Inspections & Global Pharmacovigilance Requirements The gridblock dimension of the model is 100m in all the three directions. The procedure for probabilistic forecasting through integration of microseismic observations and hydrogeological simulation comprises the following steps: Step 1, analysis of field monitored induced seismicity within the period considered is performed. Jason has a BBA from Wilfrid Laurier University, an MA in Economics from the University of Guelph, and a PhD in Economics from McGill University. Mian enjoys completing fun hobby projects such as turtle-bot navigation, object recognition, automated doggy door, 3D printed robot arm, etc. She has been instructing Human Resources Management with McMaster Continuing Education since 2016. Geothermics 82:8190, Shapiro SA (2015) Fluid-induced seismicity. Browse our listings to find jobs in Germany for expats, including jobs for English speakers or those in your native language. Cover Letter for Jobs He earned his Bachelor of Science at the University of Toronto, double majoring in Psychology and Crime & Deviance where he also studied two years of Chemical Engineering. Ramy is in his first year of teaching Design Thinking, but has previous teaching experience at the Universities of Waterloo and Toronto. Prior to this leadership role, he served the post of Senior V.P., International, for Callaway Golf. Center for Professional Innovation & Education. In this regard, accurately representing the spatial and temporal evolution of fluid pressure change within the reservoir is crucial to achieving satisfactory forecasting performance. McMaster Continuing Education is located at One James North (OJN) in Hamilton, Ontario, Canada. She is known for having strong expertise in Strategic Planning, Total Rewards and HR Change Management. Including the various typing and expression cassettes, he worked on well over 250 constructs and designed several production platforms. Lisa Gulesserian is a Learning and Development professional with a focus on leadership, career and women at work. His efforts followed through characterization and validation of these drug substances and included development of clinical and non-clinical assays. DAT 203 - Predictive Modelling and Data Mining, ACW 103 - Ready, Set, Write! Claudia is extremely enthusiastic about supporting individuals in achieving their career-related goals. Andrea is a Senior Human Resources Leader and Business Partner with over 20 years of experience in consulting, designing, implementing and communicating HR and Total Rewards programs. Geology 17:942946, Segall P, Fitzgerald SD (1998) A note on induced stress changes in hydrocarbon and geothermal reservoirs. B.A. Fracture criticality is proposed as a novel reservoir depth-independent metric for fracture slip susceptibility. Elizabeth graduated with distinction with a Bachelor of Commerce from Thompson Rivers University and holds a Bachelor of Arts in Psychology from Athabasca University. As a Consultant for Medical Devices with Biologics Consulting, Mr. Crist utilizes his scientific and regulatory expertise to assist clients in the following areas: Preparation of device submissions (Q-Sub, 510k, PMA, IDE, etc.) He also worked on the engineering design of two Aseptic Fill/Finish facilities in Europe. Kathryn is a certified career and employment specialist, adult educator and member of professional associations Human Resource Professionals Ontario (HRPA-CAN) and the Society of Human Resource Professionals (SHRM-USA). We report herein the structure-based optimization of a series of molecules culminating in the discovery of MRTX1133 (Figure 1, compound 1), a potent, selective, noncovalent KRAS G12D inhibitor with picomolar binding affinity, single digit nanomolar activity in cellular assays, and marked in vivo efficacy in tumor models harboring KRAS G12D To do this, she interacts directly with each clients SMEs and regulatory experts. His practice focuses exclusively on surety and construction law. He has direct experience in discovery, process and analytical development, vendor development, process characterization/validation, and authoring regulatory submissions. BA, Biochemistry, Cornell University, Ithaca, NY. Climate Change 2007: The Physical Science Basis. Before joining Biologics Consulting, Mr. Krueger worked as an Assistant Director overseeing the Neurosurgical Team in the Office of Product Evaluation and Qualitys Office of Neurology and Physical Medicine Devices. Established a website (http://www.SIBRA.org) dedicated to promoting the development of quantitative methods for outcome analysis and benefit-risk balance assessment in clinical trials. Considering that the fracture slippage criterion is satisfied at the source fracture for each seismic event, the integrated analysis of seismic observations and hydrogeological modelling allows for quantifying the variability of perturbations required to trigger seismicity, thus providing a probabilistic perspective in evaluating the susceptibility to injection-induced seismicity. 2016), poroelastic stressing (Segall 1989; Segall and Lu 2015), thermoelastic stressing (Segall and Fitzgerald 1998), and fault slippage-induced stress transfer (Guglielmi et al. Co-developed methods to provide blinded quantitative assessment of safety and benefit-risk balance at all phases of clinical development in support of regulatory requirements. The gradient of fluid pressure change p/h is used as the metric of fracture slip susceptibility in probabilistic seismic susceptibility evaluation in this work. 10). Prior to bluebird bio, she worked at Corbus Pharmaceuticals as a Manager in Analytical Development. 503A/503B Pharmacy Compounding, Education & Credentials He also lead the analytical and process review for the commercial transfer of Gattex (teduglitide) from Takeda to NPS Pharmaceuticals. MS, Environmental Biology, Hood College, Frederick, MD (2000), BS, General Biological Science, Emphasis in Zoology, The University of Maryland, College Park, MD (1989). He is also a certified fraud examiner and has a diploma in investigative and forensic accounting from the University of Toronto. Stephen holds a B.A. Nevertheless, it is difficult to identify the respective contribution in triggering these seismic events from re-injection into each well due to the proximity between well trajectories of the five injection wells. She is a proud graduate of McMaster University and holds a Post-Graduate Certificate in Corporate Communications. 5f). 9d). He was instrumental in the design and startup of the companys 15,000 L scale manufacturing facilities in RTP, NC and Hillerod, Denmark. 2019). The fracture criticality at the Hellisheii geothermal site was interpreted using integrated analysis of seismic observations and hydrogeological simulation of fluid injection operations in the faulted reservoir at this site. Global fossil CO 2 emissions (including cement carbonation) further increased in 2022, being now slightly above their pre-COVID-19 pandemic 2019 level. Joseph has 33 jobs listed on their profile. Orr Etiquette is Lisas etiquette and protocol consultancy that delivers training and education in all areas of etiquette and protocol to organizations, universities and schools. Born and raised in Burlington Ontario, Jonathan moved to St. Catharines to attend University which paved the way for his career in finance, starting in Toronto. Haitham Amar currently works as a Lead Data Scientist in the field of online commerce and SaaS. Volunteering is also something Rod has done throughout his career. She has senior level experience in community and corporate communications, integrated marketing communications, and public relations. She believes in the importance of educating in all areas of work and life, empowering folks to recognize their potential as a leader and peer. in Management Economics from the University of Guelph, and recently completedan M.B.A. in Leadership and Sustainability from the University of Cumbria. Kathi McBride-Anderson is a Human Resources Management Consultant with Insight HR Solutions. To ensure the reservoir behaviour to be realistically represented, the reservoir model constructed would incorporate known geological structures and be calibrated through historically matching field injection pressure time series over the injection period according to field injection rates. Outside of work, Karen Ann enjoys spending time at the cottage, fishing, kayaking, and hiking with her husband and two teenage children. The general stratigraphy at Hellisheii comprises of alternating successions of hyaloclastite formations formed during glacial periods and lava sequences from interglacial periods. She has over thirty publications in peer-reviewed journals. F2 was implemented in the model as vertical planes extending from surface lineaments. The 2021 emission increase was 0.46 GtC yr 1 (1.7 GtCO 2 yr 1), bringing 2021 emissions to 9.9 0.5 GtC yr 1 (36.3 1.8 GtCO 2 yr 1), same as the 2019 emissions level.. Dr. McEwan has also worked closely with sponsors to outsource GLP and non-clinical GLP studies to nonclinical CROs and is involved closely with nonclinical study design, implementation, monitoring and auditing of GLP study facilities. (2018). Following her Masters in Clinical Epidemiology, she pursued her PhD in Health Research Methodology at McMaster University. Prior to that role, Ms. OKelly utilized her strong background in medical devices, quality systems and compliance to develop a quality integration process for medical device product and company acquisitions. Fracture criticality, defined as the gradient of critical fluid pressure change to trigger seismicity (pc/h), is proposed as a novel reservoir depth-independent metric of fracture slip susceptibility and used in the probabilistic evaluation. His experience includes monitoring and project management across a wide variety of therapeutic areas to include drug and device studies across all phases. As shown in Fig. Moore Prize for outstanding student ofMetallurgy for the Class of 1993, has been a member of the Association for Iron & Steel Technology (AIST) since 1994, becamea Professional Engineer registered with the Professional Engineers Ontario (PEO)in 1998,holds the 2006 and 2020 Kapitan Award for best paper, the J. E. Johnson Jr. Award for 2008 and earned his Black Belt for Lean Six Sigma (LSS) in 2013. She is a member of the Womens Leadership Council of the Canadian Institute of Chartered Accountants and the International Womens Forum, and in 2009 was awarded the Womens Post Glass Slipper award for her contribution to the advancement of professional women and her work in the community. She teaches what she has applied for more than 25 years, and continues to stay current with leading practices. 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