Irvine, California, The opportunity will reside in the Transcatheter Mitral Tricuspid Therapy (TMTT) Supplier Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease. Conduct engineering activities from initial product development phase through product launch. Develop manufacturing technologies to meet new product demands. Apply Design for Manufacturability (DFM) concepts, tools and analysis. Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability. Work directly with suppliers to address specifications and quality requirements. Lead supplier validation activities, support initial builds and commercialization of new product introduction. Integrate new products into manufacturing. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Support manufacturing readiness reviews and manage components and subassembly design transfers to manufacturing.   Essential job functions include: Coordinates tooling / process capability studies as required. Responsible for new injection molding and/or metal components providing end-to-end qualification, from design input through mold validation.  This includes part design, process development on new tools, material change and process improvements. Provides technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing. Participate in technical discussions with suppliers to identify and implement improvements in products and processes. Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations and Edwards receiving inspection fixture design for Test method validation.  Respond with a high sense of urgency to quality issues and escalate / communicate appropriately. Ensure that Tier 1 suppliers are using capable Tier 2 suppliers for material and outside processing services. Work with supplier to optimize processes. Travel up to 20%. Perform other duties and responsibilities as assigned. Qualifications: Bachelor’s degree in engineering with 6 years of manufacturing engineering experience. On-site work required. Requirements/Educations/Skills: Master’s degree in Mechanical or Biomedical is preferred. Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred. Understanding of statistical techniques. CAD experience using ProE preferred. Effective communication skills are Ability to work well both independently and as a member of a team is essential. Strong analytical, problem solving, and technical writing skills are required.

Bothell, Washington, Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. #LI-DD1 Process Sciences . Bothell, Washington Do you want the opportunity to provide scientific and technical leadership in a growing function within Seattle Genetics? Through strategic thinking and strong leadership, you will be able to directly contribute to expanding the capabilities that will support all current and future combination product and device development of Seattle Genetics' antibodies and antibody-drug conjugates. This is an excellent opportunity to apply your device engineering, formulation development, and process development knowledge to drive strategic direction in a creative and highly collaborative environment. We are looking for a leader that will own initiatives, have a focus on scientific excellence, and influence the larger organization. Is this you? Description As a successful senior/principal scientist, you will enhance the long-term growth of Seattle Genetics' drug product development organization through innovation, collaboration, and scientific excellence, increasing our capabilities and improving operational efficiency to deliver transformative cancer therapies. You will be a leader in injectable formulation and drug product development working closely with Process Sciences, Analytical Sciences, Manufacturing, Regulatory Affairs, and Quality. Key responsibilities include providing product and process characterization results to regulatory filings and providing technical leadership to direct and matrixed reports. Expertise in drug delivery and device development is preferred. Responsibilities: Development of robust liquid and lyophilized products for antibodies and ADCs Design and execute formulation development studies, stability studies, and shipping/handling studies for injectable products, utilizing appropriate analytical tools Evaluate and define the optimal storage and delivery device for parenteral drug products Evaluate drug delivery performance and conduct device functionality and human factors testing Stability evaluation of material for use in toxicology and clinical studies Conduct technology transfer and scale-up of drug product manufacturing process, and support drug product and device manufacturing Lead the development work and present the results and conclusions to internal and external stakeholders Identify and lead initiatives to increase capabilities, enhance process efficiency, or improve cross-functional operations Generate technical reports and prepare CMC documents for global regulatory submissions (e.g. IND, IMPD, BLA, NDA, MAA, etc.) Supervise, coach and mentor research associate(s) and/or scientist(s) Qualifications: B.S., M.S. or Ph.D. in in Biomedical or Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Biological Sciences, Material Science, or a related discipline Ph.D. with 5+ years of industrial experience; B.S. or M.S. with commensurate amount of industrial experience 5+ years supervisory or leadership experience Experience in developing products for intravenous, subcutaneous, intramuscular, intravesical, or other parenteral routes of administration and/or experience in developing devices for injectable products such as vials, prefilled syringes, injection pens, autoinjectors, or patch pumps Demonstrated late-phase regulatory submission experience Extensive experience in support of global regulatory submissions with experience in device and combo products submissions a plus Hands-on experience and excellent understanding of analytical and biophysical product characterization preferred Hands-on experience and excellent understanding of device development and combination product development preferred Familiar with aseptic processing, and experience in technology transfer for parenteral drug product and/or device manufacturing Excellent oral and written communication skills, ability to lead cross-functional development teams, and capability to provide strategic contributions As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . #LI-DD1 Apply Here PI123052249

Bothell, Washington, Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. #LI-DD1 Product Supply Operations . Bothell, Washington Description Do you want the opportunity to utilize your small molecule chemistry expertise in a growing function within Seattle Genetics? As a member of the newly formed MSAT function, you will have a unique opportunity to apply your scientific knowledge and technical skills in readying processes for validation and supporting commercial production. Working cross functionally between Process Development and Manufacturing to ensure technology transfer is successful and Seattle Genetics has the most reliable, robust chemical processes for small molecule related components is a key requirement of this position. We're looking for someone who is enthusiastic, knowledgeable, and can step in right away to contribute as a team player to project development. Is this you? Summary: The MSAT Sr./Engineer is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to manufacturing of Seattle Genetics small molecule products, whether manufactured internally or at contract manufacturing organizations (CMO's). The Incumbent collaborates with peers from Development functions to ensure a high degree of manufacturability of processes being developed and will contribute to or lead technology transfers to or between contract manufacturers. The MSAT Sr. Scientist/Engineer will support process validation and GMP manufacturing including person-in-plant presence and trouble-shooting activities at CMO's, working closely with QA and QC. The incumbent provides technical and scientific leadership as subject matter expert (SME) relating to manufacturing processes, change control, scale-down/up studies, technology implementation projects and process optimization. Responsibilities: Supporting small molecule (drug substance and drug product) manufacturing activities for clinical and commercial manufacturing internally or at CMO's Providing technical and scientific leadership as subject matter expert (SME) relating to technology transfers, manufacturing processes, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control and process optimization Acts as Tech Transfer lead for transfer of processes into manufacturing facilities Support the DS/API throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification) Partnering with other functions to apply e.g. modelling tools ensuring that scale-down/up and characterization of manufacturing processes is robust and scientifically sound leading to a predictable and highly consistent performance and a well characterized process Providing guidance for root cause investigations of process related deviations in a timely, comprehensive and conclusive manner. Leads the data analysis of process data statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes process solutions and improvements Acting as person-in-plant during tech transfer, validation studies and commercial manufacturing Develop, optimise and review Master Batch Records and Batch Records during development, clinical supply and transfer to commercial supply Providing guidance for comprehensive facility fit assessments and gap analysis for the relevant part of the GMP manufacturing Interfacing with Development and manufacturing sites for know-how transfers and process data analysis & mapping in order to anticipate potential risks and opportunities for improvements supporting next generation manufacturing processes. Identifies and initiates process and procedural changes to improve process performance, robustness, productivity, safety, efficiency and compliance Qualifications: Demonstrated knowledge and proficiency in the synthesis and scale-up of small molecule compounds (multi-step synthesis, route selection, chromatography, crystallisation, solid form etc.) is required Experience with GMP Drug Product manufacturing for oral dosage forms (blending, compaction, tableting, film-coating, etc.) is desired Strong scientific and technical experience within relevant manufacturing process technologies and unit operations. Preferably experience with equipment utilized in commercial cGMP manufacturing facilities Good knowledge of structured methodologies for process design, scale-up/down models, process control strategies, process validation and continuous process verification The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams Experience working with Contract Manufacturing Organizations is desirable Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seattle Genetics The candidate must demonstrate high levels of integrity. Key competencies are management of complexity, driving for results, problem-solving and collaborating cross-functionally. Strong communication skills and computer literacy are essential Experience with innovation and operational excellence is desirable A good understanding of statistical analysis and continuous process verification is desirable Education: Bachelor's degree in Chemistry/Chemical Engineering or related discipline with a minimum of 8 years relevant industrial experience Alternatively, M.S. or Ph.D. in Organic Chemistry, Analytical Chemistry, Chemical Engineering or related discipline (M.S. and 6 years or Ph.D. with 4 years of industrial experience) As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . #LI-DD1 Apply Here PI123112616

Ottawa, Ontario, Canada, What you will do  We are looking for a Principal Data Scientist to act as a subject matter expert in the areas of data science, big data, and new technologies. You have demonstrated and in-depth expertise in data science and have curiosity and the technical skills to follow your curiosity.  You have a strong background in mathematics and technology, typically (but not exclusively) found in graduate research programs in Mathematics, Statistics, Computer Science, or Engineering. You have a proven track record in solving real-world business problems and a practical mindset using the more appropriate technique for the problem, whether that be a simple linear regression or a deep neural network. You must be a self-starter and a big-picture thinker with proven skills to identify solutions by discussions with clients and have extensive experience in leading data driven projects and strategic initiatives. This is a unique opportunity to apply your advanced data science skills and have an instrumental role in expanding the Bank’s capabilities in this area.  The position is a full-time term contract (18 months) and is intended to work closely with our High-Performance Computing (HPC) team working on the Terms-of-Trade Economic Model (ToTEM). ToTEM is the Bank of Canada’s main projection and policy analysis model. ToTEM is a dynamic stochastic general-equilibrium (DSGE) model. The Bank of Canada’s ToTEM is a complex DSGE model formed of hundreds of non-linear equations. We currently rely on linear approximation techniques and econometric methods combined with analytical tools to assist in forecasting and policy simulations. We are looking for a Principal Data Scientist to work on incorporation and application of machine learning techniques, artificial neural networks, large-scale optimization methods and approximation algorithms applied to solving non-linear systems of equations within the context of ToTEM.  The position will report directly to the Director of Data Science, while working in a matrix environment, responding to priorities from key clients within the Bank.  We are open to transfers, secondments, and temporary assignments to fill the position. As a Principal Data Scientist, you will lead data-driven projects, and apply artificial intelligence and machine learning techniques at every stage of work. You have a can-do attitude and will find creative ways to develop models, tools and services that drive innovation. You will:  Own the design and development of algorithms and optimize big data architectures and data pipelines Apply your in-depth theoretical and practical knowledge in machine learning and artificial intelligence to design, develop and implement new data experiments, predictive models and studies Improve upon existing methodologies by developing and testing model enhancements, running computational experiments, and fine-tuning model parameters for new models. Lead and execute deep dive diagnostic, predictive, and prescriptive analytics to support data-driven business decision making. Create alternative model approaches to assess complex model design and advance future capabilities. Mentor, develop and collaborate with other data scientists, researchers and analysts. Present analysis and resulting recommendations to senior management; leverage data to present a compelling business case to optimize and enhance models and processes What you need to succeed We are looking for an experienced Principal Data Scientist who has excellent analytical research and problem-solving skills, a self-starter and effective communicator who can share and adapt information and ideas to the target audiences, using clear and compelling written and oral communication skills. You must have proven and significant hands-on experience with end-to-end data science life cycle, with superior skills to structure and lead a project from idea to experimentation to prototype to delivery.  You are committed to learning and self-development, are organized, able to set priorities to ensure follow-through and project completion in a timely manner and able to help with research and policy initiatives. You are capable of leading projects and teams to create an environment of continuous learning and open communication.   You have proven experience in most of the following:  In-depth knowledge of optimization, large-scale optimization (linear and non-linear), linear programming techniques, convex optimization. Hands-on experience with CPLEX, Gurobi etc.  In-depth knowledge of neural networks, deep learning and reinforcement learning Collecting, organizing and manipulating big data sets, including data wrangling, dimensionality reduction and feature extraction Big data hands-on experience and big data tools for machine learning (e.g. Spark) In-depth knowledge of algorithm design, particularly for data science Fluent in object-oriented programming and scientific programming (e.g. Python, Julia) and related libraries for data science Strong programming skills conducting statistical analysis and modelling (e.g., R, Matlab) Knowledge of cloud services and SaaS would be an asset Data story-telling via visualization tools, dashboards, presentations and reports (e.g. Tableau) Comfortable with a variety of technology tools (e.g. GitHub, Jira)

Singapore, Singapore, NUS invites outstanding applicants for the position of the Head of the Department of Industrial Systems Engineering and Management.   The National University of Singapore (NUS) is a leading global university which is consistently ranked among the world’s top 30 universities and Asia’s top 2 universities. The Department of Industrial Systems Engineering and Management (ISEM) at NUS plays a pivotal role in reinforcing Singapore's key areas of excellence in ports, aviation, logistics, and high-tech industries. The department currently has more than 20 faculty members who are active research scholars, working broadly in the areas of (1) Systems, (2) Data analytics, optimization and digitization, and (3) Innovation and entrepreneurship. As a co-winner of the Next Generation Container Ports Design Challenge, the department has won multi-million dollar grants from various agencies in Singapore to develop the Next Generation Ports and Logistics Centre in NUS. For details and other achievements of the Department, please visit https://www.eng.nus.edu.sg/isem/research/research-areas/   Candidates should be internationally-recognized senior scholars in related discipline, and be expected to qualify for a Professorship in the Faculty of Engineering at NUS. In addition, ideal candidates should demonstrate successful leadership experience. He or she would have shown a strong commitment to undergraduate and graduate education, while demonstrating the ability to effectively engage and mentor junior faculty and graduate students. Experience in leading multi-disciplinary teams to tackle large-scale engineering problems at the national level will be a bonus.      Interested parties may submit their applications with a full CV and any informal/confidential enquiries to:   Chair of Industrial Systems Engineering and Management Head Search Committee c/o Dean’s Office, Human Resources Faculty of Engineering National University of Singapore Block EA, #07-26, 9 Engineering Drive 1, Singapore 117575 Email: ISEMHeadsearch@nus.edu.sg   All applications will be kept in the strictest confidence. 

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