Organovo
San Diego, CA
OrganovoAll qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.JOB DESCRIPTIONThe Director, Early Phase Project Management will be responsible for project managing Organovo's therapeutic development programs and will play a key role in driving preclinical assets into the clinic. The position will work closely with project team members representing preclinical, clinical, regulatory, operations, CMC, quality, legal, and finance departments in a collaborative environment to ensure effective and timely outcomes in all phases of a project from pre-IND to Phase 3. Will apply best practices in the development of integrated project plans and tracking of key project deliverables and timelines. Will provide regular progress updates to Senior Management regarding deliverables, timelines, and budgets. Director, Early Phase Project Management Responsibilities: Develop, track, and report on detailed project plans, milestones, key activities, progress, and adherence to budgetTake a lead role in developing specific resource allocation (person(s) responsible) for all preclinical and clinical stage programsWork with preclinical, clinical, CMC, and operational teams to identify critical issues, critical path, and project overlapProvide and manage regular program-wide dashboards for each development program, and provide regular reports (both formal and informal), to Senior ManagementWork closely with cross-functional teams to manage the timelines and coordinate the compilation of the Company's regulatory filings (including pre-IND and IND filings)Facilitate project team meetings, sub-team meetings, and cross-functional information sharing to ensure alignmentIdentify resource constraints, conflicting priorities among projects, and facilitate discussions tradeoffs, risks, and contingency plansAttend and record project team meetings including critical issues, actions and responsibilities, and generate meeting minutesParticipate in vender selection, budgeting, contract review, associated project tracking, and selected vender managementInput into/writing of key sections of regulatory documents (as required)Other Duties as assigned Director, Early Phase Project Management Skillsand Experience: Minimum six years of experience working in project management in an IND preparation settingBachelor's Degree in a scientific field is required; Master's degree preferredExperience in managing early stage development programs is essential (i.e., pre-clinical through Phase I/II). Experience in managing through Phase 3 would be a plusExperience with a cell therapy or regenerative medicine product is preferredDemonstrated experience within a regulated environment and knowledge of cGXPs, regulations, and validation standardsAbility to operate both strategically and tacticallyProactive, action oriented, and outcome focusedExcellent management, leadership, interpersonal, and communication skillsDISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by incumbents assigned to this job. This is not intended to be an exhaustive list of all the functions, responsibilities, duties and skills required for the position, and Organovo retains the discretion to modify functions, responsibilities, duties and skills at any time, including modifying the time devoted to such activities, deleting activities, and assigning other activities.Organovo is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at 858-224-1000 for assistance. #CB JOB SNAPSHOTEmployee Type: Full-TimeLocation: San Diego, CAJob Type: ManagementExperience: Not SpecifiedDate Posted: 10/15/2018PI104903956
OrganovoAll qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.JOB DESCRIPTIONThe Director, Early Phase Project Management will be responsible for project managing Organovo's therapeutic development programs and will play a key role in driving preclinical assets into the clinic. The position will work closely with project team members representing preclinical, clinical, regulatory, operations, CMC, quality, legal, and finance departments in a collaborative environment to ensure effective and timely outcomes in all phases of a project from pre-IND to Phase 3. Will apply best practices in the development of integrated project plans and tracking of key project deliverables and timelines. Will provide regular progress updates to Senior Management regarding deliverables, timelines, and budgets. Director, Early Phase Project Management Responsibilities: Develop, track, and report on detailed project plans, milestones, key activities, progress, and adherence to budgetTake a lead role in developing specific resource allocation (person(s) responsible) for all preclinical and clinical stage programsWork with preclinical, clinical, CMC, and operational teams to identify critical issues, critical path, and project overlapProvide and manage regular program-wide dashboards for each development program, and provide regular reports (both formal and informal), to Senior ManagementWork closely with cross-functional teams to manage the timelines and coordinate the compilation of the Company's regulatory filings (including pre-IND and IND filings)Facilitate project team meetings, sub-team meetings, and cross-functional information sharing to ensure alignmentIdentify resource constraints, conflicting priorities among projects, and facilitate discussions tradeoffs, risks, and contingency plansAttend and record project team meetings including critical issues, actions and responsibilities, and generate meeting minutesParticipate in vender selection, budgeting, contract review, associated project tracking, and selected vender managementInput into/writing of key sections of regulatory documents (as required)Other Duties as assigned Director, Early Phase Project Management Skillsand Experience: Minimum six years of experience working in project management in an IND preparation settingBachelor's Degree in a scientific field is required; Master's degree preferredExperience in managing early stage development programs is essential (i.e., pre-clinical through Phase I/II). Experience in managing through Phase 3 would be a plusExperience with a cell therapy or regenerative medicine product is preferredDemonstrated experience within a regulated environment and knowledge of cGXPs, regulations, and validation standardsAbility to operate both strategically and tacticallyProactive, action oriented, and outcome focusedExcellent management, leadership, interpersonal, and communication skillsDISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by incumbents assigned to this job. This is not intended to be an exhaustive list of all the functions, responsibilities, duties and skills required for the position, and Organovo retains the discretion to modify functions, responsibilities, duties and skills at any time, including modifying the time devoted to such activities, deleting activities, and assigning other activities.Organovo is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at 858-224-1000 for assistance. #CB JOB SNAPSHOTEmployee Type: Full-TimeLocation: San Diego, CAJob Type: ManagementExperience: Not SpecifiedDate Posted: 10/15/2018PI104903956
Organovo
San Diego, CA
OrganovoAll qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.JOB DESCRIPTION Scientist Responsibilities: Performs duties related to cell and tissue culture, bioprinting, compound dosing and analysis per established protocolsWill be responsible for new assay development and establishing standard operating procedures (SOPs)Utilizes a range of assay technologies tocharacterize bioprinted tissue constructs, including ELISA, qPCR, viability and histologyIndependently identifies and implements new assay technologies that have an impact on assay throughput and/or performanceIndependently designs, executes, and performs basic analysis of experiments, including independent troubleshooting.May manage individual projects, including contributing to establishing timelines and deliverablesPrimary cell culture and maintenance of bioprinted tissuesParticipates in fabrication of bioprinted tissues, including independent fabrication where applicablePrepares detailed SOPs that enable transfer of validated assays to project teams and customersReporting of results to supervisor and internally at group meetingsMay present findings at external forums (conferences)May be required to supervise junior associatesOther duties as assigned ScientistSkills andExperience: Ph.D.in Biology, Physiology, Molecular and Cellular Biology or closely related fieldMinimum3 years work experience in an industry settingExtensive experience in most of the following: mammalian tissue culture, ELISA, qPCR, flow cytometryExperience evaluating and implementing new techniquesExperience with 3D tissue culture, histology, and/or liver models is a plusAbility to work collaboratively with multi-disciplinary groups in a fast-paced work environmentAble to work independently on experimental design, execution, and analysisExcellent verbal and written communication skills and track record of ability to effectively present scientific dataDetail and task orientedPositive attitudeKeeps calm under pressureSome weekend work will be requiredDISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by incumbents assigned to this job. This is not intended to be an exhaustive list of all the functions, responsibilities, duties and skills required for the position, and Organovo retains the discretion to modify functions, responsibilities, duties and skills at any time, including modifying the time devoted to such activities, deleting activities, and assigning other activities.Organovo is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at 858-224-1000 for assistance. #CB JOB SNAPSHOTEmployee Type: Full-TimeLocation: San Diego, CAJob Type: ScienceExperience: Not SpecifiedDate Posted: 8/18/2018PI104326779
OrganovoAll qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.JOB DESCRIPTION Scientist Responsibilities: Performs duties related to cell and tissue culture, bioprinting, compound dosing and analysis per established protocolsWill be responsible for new assay development and establishing standard operating procedures (SOPs)Utilizes a range of assay technologies tocharacterize bioprinted tissue constructs, including ELISA, qPCR, viability and histologyIndependently identifies and implements new assay technologies that have an impact on assay throughput and/or performanceIndependently designs, executes, and performs basic analysis of experiments, including independent troubleshooting.May manage individual projects, including contributing to establishing timelines and deliverablesPrimary cell culture and maintenance of bioprinted tissuesParticipates in fabrication of bioprinted tissues, including independent fabrication where applicablePrepares detailed SOPs that enable transfer of validated assays to project teams and customersReporting of results to supervisor and internally at group meetingsMay present findings at external forums (conferences)May be required to supervise junior associatesOther duties as assigned ScientistSkills andExperience: Ph.D.in Biology, Physiology, Molecular and Cellular Biology or closely related fieldMinimum3 years work experience in an industry settingExtensive experience in most of the following: mammalian tissue culture, ELISA, qPCR, flow cytometryExperience evaluating and implementing new techniquesExperience with 3D tissue culture, histology, and/or liver models is a plusAbility to work collaboratively with multi-disciplinary groups in a fast-paced work environmentAble to work independently on experimental design, execution, and analysisExcellent verbal and written communication skills and track record of ability to effectively present scientific dataDetail and task orientedPositive attitudeKeeps calm under pressureSome weekend work will be requiredDISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by incumbents assigned to this job. This is not intended to be an exhaustive list of all the functions, responsibilities, duties and skills required for the position, and Organovo retains the discretion to modify functions, responsibilities, duties and skills at any time, including modifying the time devoted to such activities, deleting activities, and assigning other activities.Organovo is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at 858-224-1000 for assistance. #CB JOB SNAPSHOTEmployee Type: Full-TimeLocation: San Diego, CAJob Type: ScienceExperience: Not SpecifiedDate Posted: 8/18/2018PI104326779