Otsuka Pharmaceutical Company
We are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being.
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A Day In The Life Of

Our People

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"Otsuka-people dare to dream and we take the road less traveled to influence the future."

Kevin Donovan

SVP, OTSUKA-PEOPLE, BUSINESS SERVICES & COMMUNICATIONS

Are you an Otsuka-Person?

If your answer is yes, and you are looking for a career in an exciting and innovative company...

 

Career Opportunities

Senior Mechanical Engineer- Automation and Process Integration
ResponsibilitiesPosition acts as the primary support for automation and Process integration for Ingestible sensor manufacture and testing at Otsuka. The position will report into Senior Director-Pharmaceutical Technology, Digital medicine at OAPI, Princeton, NJ.Please note that this role can be remote or sit in Redwood City, CA.Primary Responsibilities include:Be responsible for the mechanical design and implementation of next-generation, high-volume test and production equipment for ingestible sensor fabricationInterface with cross-functional teams and upper management to clearly communicate direction and priorities to the teamWork with and manage external vendors and CMOs in the delivery of automated manufacturing and test systemsDraft and execute design control documentation including mechanical CAD models, drawings, requirements, specifications, process validations, and risk management documentsManage and lead multiple projects from developing project scopes, gathering requirements, managing timelines and implementation in a time sensitive mannerQualificationsBachelor’s Degree in Mechanical Engineering or related field. Advanced degree is a plusMinimum 10 years of experience in development and implementation of high-volume, automated platformsExperience in a regulated environment preferredThe ability to lead a project to produce successful outcomesProficiency in mechanical design/CAD (Solidworks) and data analysisExperience with high-volume, electro-mechanical systems designThe ability to interface with vendors and suppliers in a manner consistent with Otsuka’s goalsThe capacity to prioritize a list of responsibilities and projects which may often change to best meet the needs of the production lineIntegrity and patience needed to ensure all regulatory requirements are met each and every time; and the sense of responsibility to highlight and alert management when these requirements are not metThe ability to thoroughly document all experiments and findings: Process ValidationsExcellent, detail-oriented verbal and written communication skillsExperience with statistical process control (SPC) a plusSoftware programming experience a plus: MATLAB, JMPExcellent verbal and written communication skillsExcellent organizational skills along with strong attention to detailAbility to work both independently and collaboratively with small, cross-functional teamsUp to 20% domestic and international travel is required based upon business needs.  OverviewAt Otsuka, we defy limitation, so that others can too. We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility. Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com. Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Senior Mechanical Engineer- Automation and Process Integration
ResponsibilitiesPosition acts as the primary support for automation and Process integration for Ingestible sensor manufacture and testing at Otsuka. The position will report into Senior Director-Pharmaceutical Technology, Digital medicine at OAPI, Princeton, NJ.Please note that this role can be remote or sit in Redwood City, CA.Primary Responsibilities include:Be responsible for the mechanical design and implementation of next-generation, high-volume test and production equipment for ingestible sensor fabricationInterface with cross-functional teams and upper management to clearly communicate direction and priorities to the teamWork with and manage external vendors and CMOs in the delivery of automated manufacturing and test systemsDraft and execute design control documentation including mechanical CAD models, drawings, requirements, specifications, process validations, and risk management documentsManage and lead multiple projects from developing project scopes, gathering requirements, managing timelines and implementation in a time sensitive mannerQualificationsBachelor’s Degree in Mechanical Engineering or related field. Advanced degree is a plusMinimum 10 years of experience in development and implementation of high-volume, automated platformsExperience in a regulated environment preferredThe ability to lead a project to produce successful outcomesProficiency in mechanical design/CAD (Solidworks) and data analysisExperience with high-volume, electro-mechanical systems designThe ability to interface with vendors and suppliers in a manner consistent with Otsuka’s goalsThe capacity to prioritize a list of responsibilities and projects which may often change to best meet the needs of the production lineIntegrity and patience needed to ensure all regulatory requirements are met each and every time; and the sense of responsibility to highlight and alert management when these requirements are not metThe ability to thoroughly document all experiments and findings: Process ValidationsExcellent, detail-oriented verbal and written communication skillsExperience with statistical process control (SPC) a plusSoftware programming experience a plus: MATLAB, JMPExcellent verbal and written communication skillsExcellent organizational skills along with strong attention to detailAbility to work both independently and collaboratively with small, cross-functional teamsUp to 20% domestic and international travel is required based upon business needs.  OverviewAt Otsuka, we defy limitation, so that others can too. We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility. Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com. Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Executive Dir SOZOSEI Foundation (non-profit)
ResponsibilitiesThe Executive Director reports to SOZOSEI Foundation's Board of Directors and has primary responsibility for the day-to-day operation of the Foundation, including the development and implementation of organizational policies, grant-making procedures, finances, administrative systems, Foundation programs, and strategic plan. The Executive Director reports to the Foundation's Board of Directors and ensures operation of the Foundation to fulfill its purposes consistent with the Certificate of Incorporation and Bylaws. AdministrationDeveloping organizational structure and staffingMonitoring grants management Building relationships with community leadership  LeadershipWorking with the Board and Otsuka personnel who volunteer time to Foundation activities Developing and maintaining a high level of awareness of the needs of the stakeholders/communityWorking collaboratively with representatives of other sectors on issues of importance to the Foundation Representing the Foundation in local and/or national forums EvaluationEstablishing procedures for monitoring and evaluating the effectiveness of organization and its funded programs Managing Foundation employeesProviding monthly financials Providing annual report on Foundation's activitiesCommunicationServing as spokesperson for the FoundationCommunicating timely with Board any and all information necessary for the Board to function properly and to make informed decisionsPlanning and coordinating the Foundation's publications (if any) Educating and informing internal & external audiences of the Foundation's mission, objectives, and accomplishmentsFinancialPreparing annual budget Familiarity with understanding financial reportsMonitoring budget throughout the year Presenting financials to Board at all meetings Maintaining all fiscal and investment informationCommunicating on a regular basis with the Foundation's Treasurer/accountant(s) Fund RaisingDemonstrated success of utilizing various methods of fund raising Ability to secure funding donorsWillingness to build relationships with donors to create sustainable funding modelAttributes for PositionPassionate creative thinkerAbility to execute on vision/strategiesDriven by making an impactUnderstands both the non-profit and corporate cultures and ensuring independence Enjoys and is energized by working with othersAsks questions, listens and searches out other opinions and expertiseAbility to effectively communicate and think globally Willingness to make decisions in the best interests of the FoundationIntelligence, self-assuredness, a high ethical standard, inter-personal skills, independenceAbility/agility to interact with a variety of persons representing a variety of interestsIntegrity & professionalismQualificationsBA/BS requiredMaster’s Degree in health, human services, or another related field preferred Five or more years senior nonprofit management experienceSignificant experience working with a non-profit Board of Directors Demonstrated exceptional leadership skillsExperience working with non-profit organizations Experience working with pharmaceutical industry preferredStrong organizational and managerial skills Strong financial management skills, including budget preparation, analysis and reportingExcellent written and oral communication skillsStrong public speaking abilityOverviewAt Otsuka, we defy limitation, so that others can too. We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.
Executive Dir SOZOSEI Foundation (non-profit)
ResponsibilitiesThe Executive Director reports to SOZOSEI Foundation's Board of Directors and has primary responsibility for the day-to-day operation of the Foundation, including the development and implementation of organizational policies, grant-making procedures, finances, administrative systems, Foundation programs, and strategic plan. The Executive Director reports to the Foundation's Board of Directors and ensures operation of the Foundation to fulfill its purposes consistent with the Certificate of Incorporation and Bylaws. AdministrationDeveloping organizational structure and staffingMonitoring grants management Building relationships with community leadership  LeadershipWorking with the Board and Otsuka personnel who volunteer time to Foundation activities Developing and maintaining a high level of awareness of the needs of the stakeholders/communityWorking collaboratively with representatives of other sectors on issues of importance to the Foundation Representing the Foundation in local and/or national forums EvaluationEstablishing procedures for monitoring and evaluating the effectiveness of organization and its funded programs Managing Foundation employeesProviding monthly financials Providing annual report on Foundation's activitiesCommunicationServing as spokesperson for the FoundationCommunicating timely with Board any and all information necessary for the Board to function properly and to make informed decisionsPlanning and coordinating the Foundation's publications (if any) Educating and informing internal & external audiences of the Foundation's mission, objectives, and accomplishmentsFinancialPreparing annual budget Familiarity with understanding financial reportsMonitoring budget throughout the year Presenting financials to Board at all meetings Maintaining all fiscal and investment informationCommunicating on a regular basis with the Foundation's Treasurer/accountant(s) Fund RaisingDemonstrated success of utilizing various methods of fund raising Ability to secure funding donorsWillingness to build relationships with donors to create sustainable funding modelAttributes for PositionPassionate creative thinkerAbility to execute on vision/strategiesDriven by making an impactUnderstands both the non-profit and corporate cultures and ensuring independence Enjoys and is energized by working with othersAsks questions, listens and searches out other opinions and expertiseAbility to effectively communicate and think globally Willingness to make decisions in the best interests of the FoundationIntelligence, self-assuredness, a high ethical standard, inter-personal skills, independenceAbility/agility to interact with a variety of persons representing a variety of interestsIntegrity & professionalismQualificationsBA/BS requiredMaster’s Degree in health, human services, or another related field preferred Five or more years senior nonprofit management experienceSignificant experience working with a non-profit Board of Directors Demonstrated exceptional leadership skillsExperience working with non-profit organizations Experience working with pharmaceutical industry preferredStrong organizational and managerial skills Strong financial management skills, including budget preparation, analysis and reportingExcellent written and oral communication skillsStrong public speaking abilityOverviewAt Otsuka, we defy limitation, so that others can too. We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.
Assocaite Director Pharmacometrics
ResponsibilitiesThis Associate Director role will contribute to the pharmacometric strategy for projects, regulatory submissions, or interactions with authorities, working in parallel to Clinical Pharmacologists, Clinical Development Team colleagues, and colleagues across other functional areas, at a project level to align and set pharmacometrics strategy. This role will have a strong and proven pharmacokinetic/pharmacometrics knowledge, with demonstrable modelling and simulation skills, and will work in close collaboration with various non-clinical, Research, Clinical R&D, & Commercial Development/Medical Affairs functions. The role will work significantly independently, requiring minimal technical management or guidance. A considerable amount of initiative and strategic thinking will also be expected. This role may also be able to supervise more junior-level Pharmacometricians who will be serving at a project and/or a study level and will also assist in interactions with senior-level external consultants, partners, or with academic institutions. Job ResponsibilitiesLead the implementation of model-based drug development strategies for assigned preclinical, clinical, and lifecycle management projectsExecute relevant pharmacometric analyses for preclinical, clinical, and lifecycle  management projects: non-compartmental PK, PK/PD analyses, population PK and PK/PD, clinical trial simulations, meta-analyses, disease and systems biology modelling, and other modeling and simulation activities as appropriate for the project.Apply innovative analytical methods in pharmacometrics to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease progressions in support of optimal study designsProvide pharmacometrics contributions to regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings. Provides resolution of pharmacometrics queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queriesWrite Modeling & Simulation Analysis Plans and Reports. Provides input for standard operation procedures and best practices in pharmacometricsAnalyze and interpret all study PK, PK/PD and pharmacometric outcomes. Ability to create PK/PD files according to standard specifications and to generate tables and listings as requiredDevelop external alliances with partners, consultants, contract organizations and academic institutions to ensure timely conduct of all pharmacometrics deliverables for Associate Directors will act as a mentor to junior pharmacometricians, providing strategic and technical guidance for their activities.QualificationsKnowledgeIn-depth knowledge and experience in advanced PK and PK/PDAdvanced pharmacometric knowledge in one of the following core sub-area:, advanced    Exposure-Response Models, Disease Models, Physiological-Based Pharmacokinetic Models, Quantitative Systems PharmacologyKnowledge of the role of pharmacometrics in drug development and FDA/ICH          requirements for drug registrationKnowledge and application of statistics, mixed effects modelling, data mining, population PK/PD analyses and modelling, Bayesian methods, Monte-Carlo simulation, and clinical trial design and simulationAbility to understand, lead and implement all aspects of pharmacometrics needs across a variety of disease areas SkillsMust be able to apply scientific knowledge (in the areas specified above) to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.Strong organization skills.Strong communication skills.Proficiency and ability to execute analysis in NONMEM and RKnowledge of other PMx softwares such a Monolix, SAS, PKSim, MATLAB, Phoenix, SimCYP Knowledge in clinical pharmacology, clinical drug development, MIDD, and regulatory guidelines Flexibility to react rapidly to changing situations/environmentTravel 20%Education and Related ExperiencePh.D. Degree in Pharmacometrics, Clinical Pharmacology, Biomedical Engineering, Statistics, Biomedical Science or a related areaMinimum of 5 years of experience (industry, regulatory, or academia) with a proven track record within the duties mentioned aboveHands on modeling and simulation experience in PMx, PK/PD, clinical trial simulation and population based statistical analyses. Experience working in a cross-functional matrix OverviewAt Otsuka, we defy limitation, so that others can too. We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility. Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com. Disclaimer:  This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status. 
Assocaite Director Pharmacometrics
ResponsibilitiesThis Associate Director role will contribute to the pharmacometric strategy for projects, regulatory submissions, or interactions with authorities, working in parallel to Clinical Pharmacologists, Clinical Development Team colleagues, and colleagues across other functional areas, at a project level to align and set pharmacometrics strategy. This role will have a strong and proven pharmacokinetic/pharmacometrics knowledge, with demonstrable modelling and simulation skills, and will work in close collaboration with various non-clinical, Research, Clinical R&D, & Commercial Development/Medical Affairs functions. The role will work significantly independently, requiring minimal technical management or guidance. A considerable amount of initiative and strategic thinking will also be expected. This role may also be able to supervise more junior-level Pharmacometricians who will be serving at a project and/or a study level and will also assist in interactions with senior-level external consultants, partners, or with academic institutions. Job ResponsibilitiesLead the implementation of model-based drug development strategies for assigned preclinical, clinical, and lifecycle management projectsExecute relevant pharmacometric analyses for preclinical, clinical, and lifecycle  management projects: non-compartmental PK, PK/PD analyses, population PK and PK/PD, clinical trial simulations, meta-analyses, disease and systems biology modelling, and other modeling and simulation activities as appropriate for the project.Apply innovative analytical methods in pharmacometrics to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease progressions in support of optimal study designsProvide pharmacometrics contributions to regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings. Provides resolution of pharmacometrics queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queriesWrite Modeling & Simulation Analysis Plans and Reports. Provides input for standard operation procedures and best practices in pharmacometricsAnalyze and interpret all study PK, PK/PD and pharmacometric outcomes. Ability to create PK/PD files according to standard specifications and to generate tables and listings as requiredDevelop external alliances with partners, consultants, contract organizations and academic institutions to ensure timely conduct of all pharmacometrics deliverables for Associate Directors will act as a mentor to junior pharmacometricians, providing strategic and technical guidance for their activities.QualificationsKnowledgeIn-depth knowledge and experience in advanced PK and PK/PDAdvanced pharmacometric knowledge in one of the following core sub-area:, advanced    Exposure-Response Models, Disease Models, Physiological-Based Pharmacokinetic Models, Quantitative Systems PharmacologyKnowledge of the role of pharmacometrics in drug development and FDA/ICH          requirements for drug registrationKnowledge and application of statistics, mixed effects modelling, data mining, population PK/PD analyses and modelling, Bayesian methods, Monte-Carlo simulation, and clinical trial design and simulationAbility to understand, lead and implement all aspects of pharmacometrics needs across a variety of disease areas SkillsMust be able to apply scientific knowledge (in the areas specified above) to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.Strong organization skills.Strong communication skills.Proficiency and ability to execute analysis in NONMEM and RKnowledge of other PMx softwares such a Monolix, SAS, PKSim, MATLAB, Phoenix, SimCYP Knowledge in clinical pharmacology, clinical drug development, MIDD, and regulatory guidelines Flexibility to react rapidly to changing situations/environmentTravel 20%Education and Related ExperiencePh.D. Degree in Pharmacometrics, Clinical Pharmacology, Biomedical Engineering, Statistics, Biomedical Science or a related areaMinimum of 5 years of experience (industry, regulatory, or academia) with a proven track record within the duties mentioned aboveHands on modeling and simulation experience in PMx, PK/PD, clinical trial simulation and population based statistical analyses. Experience working in a cross-functional matrix OverviewAt Otsuka, we defy limitation, so that others can too. We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility. Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com. Disclaimer:  This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status. 
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