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    • exton, pennsylvania
    • permanent
    • US$110,000 - US$120,000, per year, $110k - 120k per year
    • 9 to 5
    job summary:This role is responsible for in the coordination, authoring, submitting regulatory filings to regulatory agencies to obtain registrations / clearance for medical devices. This position includes supporting internal and external customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to company products and services. location: Exton, Pennsylvaniajob type: Permanentsalary: $110,000 - 120,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Complete moderately complex regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of dossiers for submission to regulatory agencies [MAFs, 510(k)'s, technical files] in compliance with regulations, guidelines and procedures.Communicate directly with Regulatory agencies in response to request for information, regulatory inquiries or in support of customer regulatory filings.Reviews product labeling, Instructions for Use (IFUs), Patient Leaflets, Sales/Marketing Literature, Web-site information and Booth Graphics for Class I / Class II medical devices to ensure adherence to applicable regulations and standards.Guide research initiatives relating to medical device and combination product development.Reviews information to relating to medical device complaints.Work with RA team to build Regulatory strategies for combination product development platform.Participate on project development teams and provide regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.Review technical and design specifications, project documentation, regulatory plans, etc. providing guidance and direction where applicable.Provide customers with product related information and data as required for regulatory submissions to European and Rest of World agencies.Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.Train, mentor and/or guide the activities of direct reports, RA staff members and peers to define and achieve personal, departmental and corporate objectives, as applicable.Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to products and business.Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goalsMaintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change.Adhere to all applicable government and company regulations, practices and procedures to maintain compliance.Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required. qualifications:Bachelor, Master's degree, or PhD in related disciplineBachelors with 3-5 years; or Master's degree/PhD with 1-3 years Medical Device / Combination Product regulatory experience.Preferred:Bachelor Science of Nursing (BSN) or equivalent clinical degreeExperience in Medical Device Post Market Surveillance, Clinical Evaluation Reports, Heath Hazard EvaluationExperience in regulatory medical device development and registration of class I and class II medical devices.Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). Awareness of regulations and guidelines related to preparation and administration of medicinal products.Strong working knowledge of medical device and combination product regulationsKnowledge of pharmaceutical clinical development.Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is requiredExcellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external skills: Regulatory Affairs StrategyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:This role is responsible for in the coordination, authoring, submitting regulatory filings to regulatory agencies to obtain registrations / clearance for medical devices. This position includes supporting internal and external customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to company products and services. location: Exton, Pennsylvaniajob type: Permanentsalary: $110,000 - 120,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Complete moderately complex regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of dossiers for submission to regulatory agencies [MAFs, 510(k)'s, technical files] in compliance with regulations, guidelines and procedures.Communicate directly with Regulatory agencies in response to request for information, regulatory inquiries or in support of customer regulatory filings.Reviews product labeling, Instructions for Use (IFUs), Patient Leaflets, Sales/Marketing Literature, Web-site information and Booth Graphics for Class I / Class II medical devices to ensure adherence to applicable regulations and standards.Guide research initiatives relating to medical device and combination product development.Reviews information to relating to medical device complaints.Work with RA team to build Regulatory strategies for combination product development platform.Participate on project development teams and provide regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.Review technical and design specifications, project documentation, regulatory plans, etc. providing guidance and direction where applicable.Provide customers with product related information and data as required for regulatory submissions to European and Rest of World agencies.Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.Train, mentor and/or guide the activities of direct reports, RA staff members and peers to define and achieve personal, departmental and corporate objectives, as applicable.Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to products and business.Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goalsMaintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change.Adhere to all applicable government and company regulations, practices and procedures to maintain compliance.Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required. qualifications:Bachelor, Master's degree, or PhD in related disciplineBachelors with 3-5 years; or Master's degree/PhD with 1-3 years Medical Device / Combination Product regulatory experience.Preferred:Bachelor Science of Nursing (BSN) or equivalent clinical degreeExperience in Medical Device Post Market Surveillance, Clinical Evaluation Reports, Heath Hazard EvaluationExperience in regulatory medical device development and registration of class I and class II medical devices.Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). Awareness of regulations and guidelines related to preparation and administration of medicinal products.Strong working knowledge of medical device and combination product regulationsKnowledge of pharmaceutical clinical development.Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is requiredExcellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external skills: Regulatory Affairs StrategyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • exton, pennsylvania
    • permanent
    • US$110,000 - US$120,000, per year, $110k - 120k per year
    • 9 to 5
    job summary:This role is responsible for in the coordination, authoring, submitting regulatory filings to regulatory agencies to obtain registrations / clearance for medical devices. This position includes supporting internal and external customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to company products and services. location: Exton, Pennsylvaniajob type: Permanentsalary: $110,000 - 120,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Complete moderately complex regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of dossiers for submission to regulatory agencies [MAFs, 510(k)'s, technical files] in compliance with regulations, guidelines and procedures.Communicate directly with Regulatory agencies in response to request for information, regulatory inquiries or in support of customer regulatory filings.Reviews product labeling, Instructions for Use (IFUs), Patient Leaflets, Sales/Marketing Literature, Web-site information and Booth Graphics for Class I / Class II medical devices to ensure adherence to applicable regulations and standards.Guide research initiatives relating to medical device and combination product development.Reviews information to relating to medical device complaints.Work with RA team to build Regulatory strategies for combination product development platform.Participate on project development teams and provide regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.Review technical and design specifications, project documentation, regulatory plans, etc. providing guidance and direction where applicable.Provide customers with product related information and data as required for regulatory submissions to European and Rest of World agencies.Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.Train, mentor and/or guide the activities of direct reports, RA staff members and peers to define and achieve personal, departmental and corporate objectives, as applicable.Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to products and business.Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goalsMaintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change.Adhere to all applicable government and company regulations, practices and procedures to maintain compliance.Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required. qualifications:Bachelor, Master's degree, or PhD in related disciplineBachelors with 3-5 years; or Master's degree/PhD with 1-3 years Medical Device / Combination Product regulatory experience.Preferred:Bachelor Science of Nursing (BSN) or equivalent clinical degreeExperience in Medical Device Post Market Surveillance, Clinical Evaluation Reports, Heath Hazard EvaluationExperience in regulatory medical device development and registration of class I and class II medical devices.Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). Awareness of regulations and guidelines related to preparation and administration of medicinal products.Strong working knowledge of medical device and combination product regulationsKnowledge of pharmaceutical clinical development.Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is requiredExcellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external skills: Regulatory Affairs StrategyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:This role is responsible for in the coordination, authoring, submitting regulatory filings to regulatory agencies to obtain registrations / clearance for medical devices. This position includes supporting internal and external customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to company products and services. location: Exton, Pennsylvaniajob type: Permanentsalary: $110,000 - 120,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Complete moderately complex regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of dossiers for submission to regulatory agencies [MAFs, 510(k)'s, technical files] in compliance with regulations, guidelines and procedures.Communicate directly with Regulatory agencies in response to request for information, regulatory inquiries or in support of customer regulatory filings.Reviews product labeling, Instructions for Use (IFUs), Patient Leaflets, Sales/Marketing Literature, Web-site information and Booth Graphics for Class I / Class II medical devices to ensure adherence to applicable regulations and standards.Guide research initiatives relating to medical device and combination product development.Reviews information to relating to medical device complaints.Work with RA team to build Regulatory strategies for combination product development platform.Participate on project development teams and provide regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.Review technical and design specifications, project documentation, regulatory plans, etc. providing guidance and direction where applicable.Provide customers with product related information and data as required for regulatory submissions to European and Rest of World agencies.Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.Train, mentor and/or guide the activities of direct reports, RA staff members and peers to define and achieve personal, departmental and corporate objectives, as applicable.Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to products and business.Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goalsMaintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change.Adhere to all applicable government and company regulations, practices and procedures to maintain compliance.Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required. qualifications:Bachelor, Master's degree, or PhD in related disciplineBachelors with 3-5 years; or Master's degree/PhD with 1-3 years Medical Device / Combination Product regulatory experience.Preferred:Bachelor Science of Nursing (BSN) or equivalent clinical degreeExperience in Medical Device Post Market Surveillance, Clinical Evaluation Reports, Heath Hazard EvaluationExperience in regulatory medical device development and registration of class I and class II medical devices.Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). Awareness of regulations and guidelines related to preparation and administration of medicinal products.Strong working knowledge of medical device and combination product regulationsKnowledge of pharmaceutical clinical development.Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is requiredExcellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external skills: Regulatory Affairs StrategyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • exton, pennsylvania
    • permanent
    • US$75,000 - US$80,000, per year, $75k - 80k per year
    • 9 to 5
    job summary:This role has been created for an individual to work within our newly created laboratory facility.The role will undertake applied research experimentation to evaluate products and their readiness for the packaging challenges that an exciting new field of healthcare present. Experiments will support life science projects focused on product readiness in the areas of thermodynamics, biological media, and applications, sealing and crimping, and material sciences and will help the company establish performance windows of container closure systems. The data generated will support ongoing research collaborations with established, thought-leading academic research groups in the fields of biomedicine, physical sciences, engineering, and applied technology. location: Exton, Pennsylvaniajob type: Permanentsalary: $75,000 - 80,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Perform experiments to support research program objectives and meet deliverables.Accurately generate and record data, follow test methods, and help develop new test methods.Prepare test samples and assist other laboratory analysts as needed.Adhere to required internal QA procedures and cGMP/GLP regulations as needed.Record and report the outputs of various research projects internally through technical reports, presentations, and internal social media.Act as a supportive team member on various projects within the Advanced Therapies group by performing other duties as assigned based on business needs.Solve problems creatively using personal judgement and persevere when setbacks threaten project goals.Able to be aware of all relevant SOPs as per company policy as they are related to the position covered by this job description. qualifications:Bachelors in biological sciences or engineering, preferably in a biomedical engineering or equivalent multidisciplinary engineering field.Minimum of 3 years' experience in the biopharmaceutical or medical device industry.Strong interpersonal skills, known to collaborate well with others and maintain research relationships.Dependable, detail oriented, able to multi-task to support timely research projects and multiple recurring weekly tasks.Exposure to a variety of lab techniques in biology and material sciences, with an emphasis on sterile technique.Demonstrated proficiency with Microsoft programs and familiarity with Adobe and GraphPad preferred.Excellent written and verbal communication with an ability to disseminate scientific research to a non-technical audience.Preferred:Master's in biology, chemistry, biomedical, chemical engineering or equivalent scientific or engineering discipline.Minimum 3 years' professional experience or 1+ years' experience with an advanced degree.Scientific publication track record and/or conference proceedings in a chosen field of expertise.Biology research experience preferred. Exposure to a variety of lab techniques including, but not limited to, molecular biology, cell biology, protein chemistry, oncology, physiology, materials sciences testing, and sterile technique.Participate in designing experiments and project proposals to evaluate and test different hypotheses.Understanding of regulated manufacturing environments, i.e., aseptic and GMP production. skills: Cell BiologyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:This role has been created for an individual to work within our newly created laboratory facility.The role will undertake applied research experimentation to evaluate products and their readiness for the packaging challenges that an exciting new field of healthcare present. Experiments will support life science projects focused on product readiness in the areas of thermodynamics, biological media, and applications, sealing and crimping, and material sciences and will help the company establish performance windows of container closure systems. The data generated will support ongoing research collaborations with established, thought-leading academic research groups in the fields of biomedicine, physical sciences, engineering, and applied technology. location: Exton, Pennsylvaniajob type: Permanentsalary: $75,000 - 80,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Perform experiments to support research program objectives and meet deliverables.Accurately generate and record data, follow test methods, and help develop new test methods.Prepare test samples and assist other laboratory analysts as needed.Adhere to required internal QA procedures and cGMP/GLP regulations as needed.Record and report the outputs of various research projects internally through technical reports, presentations, and internal social media.Act as a supportive team member on various projects within the Advanced Therapies group by performing other duties as assigned based on business needs.Solve problems creatively using personal judgement and persevere when setbacks threaten project goals.Able to be aware of all relevant SOPs as per company policy as they are related to the position covered by this job description. qualifications:Bachelors in biological sciences or engineering, preferably in a biomedical engineering or equivalent multidisciplinary engineering field.Minimum of 3 years' experience in the biopharmaceutical or medical device industry.Strong interpersonal skills, known to collaborate well with others and maintain research relationships.Dependable, detail oriented, able to multi-task to support timely research projects and multiple recurring weekly tasks.Exposure to a variety of lab techniques in biology and material sciences, with an emphasis on sterile technique.Demonstrated proficiency with Microsoft programs and familiarity with Adobe and GraphPad preferred.Excellent written and verbal communication with an ability to disseminate scientific research to a non-technical audience.Preferred:Master's in biology, chemistry, biomedical, chemical engineering or equivalent scientific or engineering discipline.Minimum 3 years' professional experience or 1+ years' experience with an advanced degree.Scientific publication track record and/or conference proceedings in a chosen field of expertise.Biology research experience preferred. Exposure to a variety of lab techniques including, but not limited to, molecular biology, cell biology, protein chemistry, oncology, physiology, materials sciences testing, and sterile technique.Participate in designing experiments and project proposals to evaluate and test different hypotheses.Understanding of regulated manufacturing environments, i.e., aseptic and GMP production. skills: Cell BiologyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • exton, pennsylvania
    • permanent
    • US$90,000 - US$100,000, per year, $90k - 100k per year
    • 9 to 5
    job summary:This role is responsible for driving the future of the company by developing innovative products designed to improve patient lives. This role is tasked with working on research on behalf of the rest of the R&D organization and will keenly focus on technology fields that are adjacent and transformational to core products.This specialist role is for a highly collaborative candidate who is vastly knowledgeable about the cryogenics of biological material, and the cold chain, storage, and distribution networks utilized by advanced therapies manufacturers. The role will be expected to interface with both externally with clinicians, researchers, regulators, and biotech companies as well as internally with Sales, Marketing and Scientific teams to identify the unmet packaging and delivery needs for these new pharmaceuticals.In collaborating across this wide array of stakeholders, the candidate would use the insights gained to design and execute experimental studies. These will include establishing best practice using current products as well as establishing future advanced therapy packaging requirements. These will inform development decisions for next generation containment and delivery systems to be developed in the coming years. location: Exton, Pennsylvaniajob type: Permanentsalary: $90,000 - 100,000 per yearwork hours: 9 to 5education: Doctorate responsibilities:Design experimental plans and project proposals to evaluate different technologies and ideas and test hypotheses across cell and gene therapy freezing, storing, thawing and delivery.Manage and contribute to complex research projects across several technologies and a variety of project formats, from short-term student internships, through to feasibility projects and long-term collaborations.Analyze and evaluate experimental results to make well-reasoned strategic recommendations that are to be disseminated internally to inform future product development decisions.Actively seek out new and emerging technologies and therapies, track publications, identify and highlight active academics and keep organization informed of research and industry developments.Solve complex technical challenges that arise on both internal and external projects. Provide new perspectives and arrive at solutions based on pooling multiple sources of information.Provide subject matter expertise across the organization in the field(s) of cryobiology.Collaborate and gain commitment with stakeholders internally as well as externally with research partners (postdocs, professors, and clinicians) as needed to achieve project objectives.Capture project outputs in appropriate format including technical reports, presentation slides, research posters, invention disclosures or as project permits.Travel to select targeted scientific and research conferences to learn and present out research findings with intention of increasing scientific reputation in novel fields.Solve problems using own judgement and persevere when setbacks threaten project goals.Participate as team member on various projects within group and performs other duties as assigned based on business needs. qualifications:Master's in biology, biochemistry, biomedical engineering, or equivalent scientific discipline.Minimum of 5 years of experience, can include time spent either in industry or graduate school.In depth life sciences knowledge including experience, through either research or industry background, of one or more cell or gene therapies named in job summary, i.e. understands production methods, cryogenic storage, underlying modes of action, scientific principles, etc.Demonstrated ability to lead complex research projects, can either be shown in relevant industry projects or via strong collaborative postgraduate research.Proficient with conventional lab equipment used for cryopreservation of biological material as well as common analytical techniques used in assessing cryogenic and biological performance.Strong interpersonal skills to generate, maintain and grow research relationships and gain commitment from all internal and external stakeholders across research projects.Willingness to learn and to independently explore new fields of research, understand nascent technologies and be able to generate research project/grant proposals with minimal guidance.Excellent written and verbal communication and ability to articulately disseminate scientific research to a variety of different audiences, from expert through to non-technical.Preferred:PhD in biology, biochemistry, biomedical engineering, or equivalent scientific discipline.Scientific publication track record and/or conference proceedings in a chosen field of expertise.Existing established North American network of academic and/or industry collaborators.Understanding of regulated manufacturing environments, i.e. aseptic and GMP production.Able to be aware of all relevant SOPs as per company policy as they are related to the position covered by this job description.Must maintain the ability to work well with others in a variety of situations.Must be able to multi-task, work under time constraints, problem solve, and prioritize. skills: Cell BiologyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:This role is responsible for driving the future of the company by developing innovative products designed to improve patient lives. This role is tasked with working on research on behalf of the rest of the R&D organization and will keenly focus on technology fields that are adjacent and transformational to core products.This specialist role is for a highly collaborative candidate who is vastly knowledgeable about the cryogenics of biological material, and the cold chain, storage, and distribution networks utilized by advanced therapies manufacturers. The role will be expected to interface with both externally with clinicians, researchers, regulators, and biotech companies as well as internally with Sales, Marketing and Scientific teams to identify the unmet packaging and delivery needs for these new pharmaceuticals.In collaborating across this wide array of stakeholders, the candidate would use the insights gained to design and execute experimental studies. These will include establishing best practice using current products as well as establishing future advanced therapy packaging requirements. These will inform development decisions for next generation containment and delivery systems to be developed in the coming years. location: Exton, Pennsylvaniajob type: Permanentsalary: $90,000 - 100,000 per yearwork hours: 9 to 5education: Doctorate responsibilities:Design experimental plans and project proposals to evaluate different technologies and ideas and test hypotheses across cell and gene therapy freezing, storing, thawing and delivery.Manage and contribute to complex research projects across several technologies and a variety of project formats, from short-term student internships, through to feasibility projects and long-term collaborations.Analyze and evaluate experimental results to make well-reasoned strategic recommendations that are to be disseminated internally to inform future product development decisions.Actively seek out new and emerging technologies and therapies, track publications, identify and highlight active academics and keep organization informed of research and industry developments.Solve complex technical challenges that arise on both internal and external projects. Provide new perspectives and arrive at solutions based on pooling multiple sources of information.Provide subject matter expertise across the organization in the field(s) of cryobiology.Collaborate and gain commitment with stakeholders internally as well as externally with research partners (postdocs, professors, and clinicians) as needed to achieve project objectives.Capture project outputs in appropriate format including technical reports, presentation slides, research posters, invention disclosures or as project permits.Travel to select targeted scientific and research conferences to learn and present out research findings with intention of increasing scientific reputation in novel fields.Solve problems using own judgement and persevere when setbacks threaten project goals.Participate as team member on various projects within group and performs other duties as assigned based on business needs. qualifications:Master's in biology, biochemistry, biomedical engineering, or equivalent scientific discipline.Minimum of 5 years of experience, can include time spent either in industry or graduate school.In depth life sciences knowledge including experience, through either research or industry background, of one or more cell or gene therapies named in job summary, i.e. understands production methods, cryogenic storage, underlying modes of action, scientific principles, etc.Demonstrated ability to lead complex research projects, can either be shown in relevant industry projects or via strong collaborative postgraduate research.Proficient with conventional lab equipment used for cryopreservation of biological material as well as common analytical techniques used in assessing cryogenic and biological performance.Strong interpersonal skills to generate, maintain and grow research relationships and gain commitment from all internal and external stakeholders across research projects.Willingness to learn and to independently explore new fields of research, understand nascent technologies and be able to generate research project/grant proposals with minimal guidance.Excellent written and verbal communication and ability to articulately disseminate scientific research to a variety of different audiences, from expert through to non-technical.Preferred:PhD in biology, biochemistry, biomedical engineering, or equivalent scientific discipline.Scientific publication track record and/or conference proceedings in a chosen field of expertise.Existing established North American network of academic and/or industry collaborators.Understanding of regulated manufacturing environments, i.e. aseptic and GMP production.Able to be aware of all relevant SOPs as per company policy as they are related to the position covered by this job description.Must maintain the ability to work well with others in a variety of situations.Must be able to multi-task, work under time constraints, problem solve, and prioritize. skills: Cell BiologyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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