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Research And Development Scientist jobs at LakePharma - 138 jobs

  • Lead R&D Data Scientist

    Labcorp 4.5company rating

    Remote

    Labcorp Genetics (formerly Invitae) is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry, by making clinical-grade genetic information affordable and accessible to guide health decisions across all stages of life. The genomics insights team leverages clinical genomic expertise, our massive genetics, laboratory and linked public/private datasets, and the latest AI/ML technologies to improve diagnosis, clinical care, and treatment options. We design and develop robust, quantitative, and scalable systems for variant interpretation and disease insights. Our research findings are broadly disseminated to improve testing guidelines, optimize reimbursement rates, and educate the healthcare ecosystem. We are seeking a Lead R&D Data Scientist to join our team and contribute to these initiatives. Duties and Responsibilities: Lead and deliver the translation of complex biological and clinical questions into actionable analysis plans. Architect and implement robust data pipelines that integrate large-scale genomic, phenotypic, laboratory, and real-world clinical datasets. Conduct repeatable data analysis and modeling with a high degree of scientific and statistical rigor, for complex tasks such as understanding patient trajectories, elucidating variant effect, and identifying genotype-phenotype associations. Write clean, maintainable, and well-documented code following best practices for version control, testing, and scalability. Prepare technical reports, peer-reviewed publications, and conference presentations to share research outcomes with internal stakeholders and the broader scientific community. Collaborate closely with both internal and external stakeholders to drive impactful research and development initiatives. Ensure high standards of data privacy, security, and compliance are maintained in all projects. Qualifications: Masters degree, or equivalent industry experience in Computer Science, Statistics, Data Science, Computational Biology, or a related field. 5+ years of hands-on experience in data science and statistical methods, as applied to large biomedical datasets. Experience working within a collaborative technical team with strong software engineering practices. Proficiency in modern programming languages (Python and SQL), shell scripting, and version control (Git). Experience with data management, ETL, and business intelligence tools. Excellent communication skills for presenting research findings to diverse audiences. Preferred Qualifications: Ph.D Experience with big data technologies (Snowflake, Databricks, etc.) and visualization/dashboarding (Looker, Dash, etc.). Experience with high performance computing (SGE etc.). Experience in the development and validation of complex computational models for biological data, in particular machine learning and bioinformatics techniques. Understanding of data privacy, security, and ethical considerations in clinical and biological research. Previous published work in genetics, functional genomics, or clinical research. This position is not eligible for visa sponsorship. Application window closes: 02/14/2026 Pay Range: $100,000.00 - $155,000.00 a year Schedule/Shift: M-F, 8-5 EST All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. The position is also eligible for an annual bonus under the Labcorp Bonus Plan. Bonuses are payable based on corporate and/or business segment performance and are subject to individual performance modifiers. Compensation may also include discretionary short- and long-term incentive packages. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information, please click here Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
    $100k-155k yearly Auto-Apply 8d ago
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  • Pharmacovigilance Scientist

    Axsome Therapeutics, Inc. 3.6company rating

    New York, NY jobs

    Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Pharmacovigilance Scientist to establish and execute pharmacovigilance (PV) systems and procedures, with a strong focus on maintaining high-quality standards. This role is responsible for supporting the Pharmacovigilance (PV) Science function under the guidance of the PV physician and providing oversight of ICSR assessment, signal detection, medical surveillance and risk management activities for investigational products in clinical development and marketed products. This position collaborates with key internal stakeholders, including Clinical Development, Commercial, Medical Information, Medical Affairs, Quality, Regulatory and Legal, as well as multiple external Service Providers and partners on pharmacovigilance-related matters. This position reports to Executive Director of Pharmacovigilance/Drug Safety and is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following: * Assist safety physician to enhance safety surveillance and signal detection by monitoring and analyzing safety data from various sources to identify potential safety signals or trends related to investigational and marketed products * Contribute to the creation and execution of risk minimization measures to mitigate identified risks. * Support the preparation pharmacovigilance aggregate safety reports (e.g., PADER, PSURs, DSURs) to regulatory authorities to meet compliance requirements. * Collaborate with PV physician/PV operations and key stakeholders to request/receive applicable sections of the report * Provide training and guidance to other functions to address ad hoc questions and issues * Ensure timely finalization of the reports to meet the submission timelines of relevant health authorities and other external stakeholders * Collaborate and communicate with cross-functional teams to ensure effective safety monitoring and communication * Support the safety review team (SRT) and coordinates all safety topic discussion and documentation. * Ensure appropriate stakeholder representation and input at SRT * Ensure all data is appropriately compiled and presented at SRT for team review * Liaise with SRT chair to facilitate communication and support for decisions resulting from the SRT (e.g. update of RMPs, labeling, regulatory notifications etc.) * Contribute to clinical trials by providing safety input and reviewing documents such as Clinical Study Reports (CSRs), protocols, and investigator brochures (IB), ICF etc. * Provide support for the processing of individual case safety reports (ICSRs) and ensure data accuracy and completeness for investigational and marketed products * Support the PV SOP updates * Oversee vendor safety process, e.g., signal detection, validation and assessment. * Participate in audit/inspection preparedness activities and provide support during regulatory inspections in collaboration with team members * Participate in new study initiation to ensure PV requirements are met including but not limited to safety reporting, query resolution, SAR reconciliation, un-blinding process, and safety reporting training * Evaluate and improve current PV processes, as needed, to strengthen medical surveillance and risk management process ensuring alignment with best practices Requirements / Qualifications * Master's degree in health-discipline or equivalent required, RN, R.Ph, or Pharm D degree is highly preferred * 5+ years of progressively responsible Pharmacovigilance experience in a pharmaceutical, biotechnology, or related environment with focused experience in signal detection, safety surveillance, risk mitigation and risk management * Extensive experience in case processing, regulatory requirements of ICSRs, MedDRA, WHODD, project management * Experience in submission activities in both FDA and EU is preferred, but not required * Must demonstrate the ability to draft reports, business correspondence, and procedures, and to effectively present information and respond to questions from internal and external stakeholders, both domestic and international * Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles. Experience and Knowledge * Knowledge of ICH E2B(R2) and (R3) specifications and entry guidance. * Knowledge of global pharmacovigilance reporting rules and timelines, including but not limited to Health Canada, FDA and EMA. * Knowledge of relevant food and drug administration (FDA), European union (EU) and international conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance. * Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc. * Experience with clinical and/or post-marketing case assessment, including medical terminologies, MedDRA and WHO DD coding and narrative writing. * Experience with safety database is required; ARISg is a plus but not mandatory. * Experience with Veeva is a plus but not mandatory. * Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members * Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines * Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations * Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects * Excellent verbal and written communication and skills * Excellent in detailed-oriented tasks. Salary & Benefits The anticipated salary range for this role is $150,000 - $185,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
    $150k-185k yearly 60d+ ago
  • Scientific Technical Support Scientist - NGS

    Twist Bioscience 4.4company rating

    Remote

    The Scientific Technical Support Specialist will be responsible for providing best in class technical support and consultation to customers and Twist Bioscience's field-based sales team. The position will specifically support Twist's NGS Application Product lines. What You'll Be Doing: Provide clear, accurate, and solutions-oriented technical support via phone, email, and/or live chat to customers and field sales teams. Ensure customer interactions promote Twist's brand and create high customer loyalty and satisfaction. Provide basic application support and perform troubleshooting for field sales teams and customers. Assist in the development and implementation of plans to improve technical services and capabilities while working towards corporate/individual revenue and customer allegiance goals. Effectively communicate competitive information and additional sales opportunities to Marketing and Field Sales. Provide feedback to Production personnel for product improvements. Track customer satisfaction and work to continually improve customer satisfaction. Facilitate and participate in customer complaint troubleshooting with the Development and Production teams and other technical experts. Participate and assist in technical training sessions, as needed. Each Twist employee is responsible for complying with applicable Quality Management System (QMS)/Information Security Management System (ISMS) standards in the execution of their daily activities and ensuring product or service meets regulatory requirements, customer requirements and the established QMS/ISMS policies and procedures. What You'll Bring to the Team: Ph.D preferred or Master's degree in Molecular Biology, Genetics, or related Life Sciences degree with 3-5 years of industry experience. Requires an in-depth knowledge of synthetic DNA and molecular biology laboratory techniques; minimum of 3 years hands-on experience using NGS technologies Preferred Target Enrichment Must be able to communicate effectively with a wide variety of people and have strong interpersonal skills. Excellent computer skills using Microsoft Office and G-Suite; experience with Salesforce and Customer Relationship Management and Enterprise Resource Planning software a plus. Experience providing remote technical support a plus. Flexible work hours are a requirement, this role supports different time zones. The base cash compensation for this California-based role is below. In addition to base salary, this role is eligible for bonus, equity, and a generous benefits package. Final compensation amounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensation may be different in other locations.San Francisco Bay Area Pay Range$100,000-$120,000 USD
    $100k-120k yearly Auto-Apply 49d ago
  • Variant Scientist III - Invitae

    Labcorp 4.5company rating

    Remote

    Invitae, part of Labcorp, is looking for a Variant Scientist III to join its team! The Variant Scientist will contribute to a high-performing team that supports variant interpretation and clinical reporting across our product portfolio. The position will be responsible for curating genetic content across different clinical areas to enhance our offerings. Additionally, the role supports development and implementation of processes and tools to improve and scale variant interpretation and clinical reporting. Please note: this position has the option to be 100% remote in the US, or physically located at our laboratory in San Francisco, CA. The schedule for this position will be Monday-Friday, 8am-5pm local time zone. Responsibilities: Up to 75% of your time performing variant interpretation (aka variant curation) using our validated in-house genetic evidence system to generate clear and concise clinical reports Critically analyze and interpret clinical and genetic information, including published literature, public and private databases, functional studies and modeling, as well as patient clinical records Develop, curate, and refine genetic content for a broad range of genetic disorders to support our operations and clinical offerings Achieve and maintain technical and clinical competency through initial and ongoing training in a fast-paced and dynamic environment Receive and provide case-related and performance-related feedback in a direct and supportive setting Participate in development and refinement of tools for analyzing genetic data Support implementation of process improvements to optimize and scale clinical reporting operations Engage with Manager/Senior Manager to support team and departmental objectives Develop and maintain standard operating procedures (SOPs) and address internal and client-facing queries regarding variant interpretation and clinical reporting Other duties as assigned Requirements: Ph.D. in Life Sciences (Genetics / Molecular Genetics /Human Genetics) with minimum 1 year of variant interpretation experience OR Master's degree in Genetic Counseling, biological sciences, molecular genetics, human genetics or a related field with a minimum of 3 years of relevant variant interpretation experience OR Bachelor's degree in Genetics, biological sciences, molecular genetics, human genetics or related field with minimum 5 years of relevant variant interpretation experience Preferred Requirements: Experience in a CLIA diagnostic laboratory, familiarity with next-generation sequencing, genetic variant curation, interpretation of clinical relevance, and knowledge of advanced methods of copy number detection and copy number variant interpretation Experience in one or more of the following areas: hereditary pediatric disorders, ophthalmology, and/or carrier testing Skills and Competencies: Excellent written, verbal, and interpersonal communication skills Ability to adapt to significant change that is inherent in development and innovation Desire to work in and contribute to a fast-paced, highly collaborative environment Demonstrated ability to understand, synthesize, and coherently evaluate complex genetic information. Strong critical thinking skills and ability to work independently. Application Window Closes: 1/27/26 **Salary Range: $119,000 - $172,000 / year All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
    $119k-172k yearly Auto-Apply 2d ago
  • Translational Scientist - Hybrid

    Caris Life Sciences 4.4company rating

    Tempe, AZ jobs

    **At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives.** We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: _"What would I do if this patient were my mom?"_ That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose. **Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.** **Position Summary** Translational Scientist plays a key role in bridging scientific insight and regulatory requirements for development of Next-generation sequencing (NGS) based in vitro diagnostics (IVDs), with a focus on technical documentation throughout the product life cycle and cross-functional collaboration. This role will support analytical verification and validation activities including but not limited to study designs, sample requirements, protocol and report writing and will ensure those executing study protocols understand the scientific rationale. The Translational Scientist will also serve as a liaison between Product Development and Quality Assurance/Regulatory Affairs to ensure the product development process aligns with applicable regulatory requirements. This position requires strong interpersonal and organizational skills in addition to scientific writing skills and regulatory awareness for supporting regulatory submissions of NGS based companion diagnostics (CDx) devices at Caris. **Job Responsibilities** + Composes scientific and technical documents throughout the product development process through collaboration with cross-functional teams including Product Development, Bioinformatics/Statisticians, Molecular Operations, QA, and RA. + Support analytical verification and validation (V&V) studies for oncology-focused IVD assays: + Contribute to study design and sample planning. + Draft and review V&V protocols and reports. + Ensure scientific rigor in data interpretation for analytical performance metrics (e.g., LoD, specificity, precision) + Translate complex scientific rationale into clear guidance for execution teams. + Participate in cross-functional risk assessments (e.g., FMEA), design reviews and contribute to design control deliverables including design inputs, outputs and traceability. + Collaborate with Regulatory Affairs to prepare and review regulatory submissions (e.g., FDA 510(k), PMA, EUA, IVDR), including pre- and post-market documents. + Extract, synthesize, and format study results for inclusion in regulatory submission documents. + Ensure compliance with applicable regulations including FDA 21 CFR Part 820, ISO 13485, IVDR, and country-specific requirements. + Stay up to date with evolving oncology biomarkers, therapeutic targets, and regulatory guidance relevant to oncology diagnostics and companion diagnostics (CDx). + Must be tolerant to change, ready to take on new challenges and open to learning new skills. **Required Qualifications** + MS degree in Molecular Biology, Biochemistry, Pharmacology, or a related life sciences field with 5+ years of relevant industry experience; or a PhD with relevant training and experience. + Strong scientific writing experience (e.g., validation documents, protocols, SOPs, peer-reviewed publications). + Solid understanding of molecular biology principles and assay development processes. + Familiarity with Design Control and product development within a regulated (IVD or medical device) environment. + Ability to work effectively across interdisciplinary teams and manage multiple priorities. + Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working. + Knowledge of Internet for business use. **Preferred Qualifications** + Hands-on or scientific knowledge of Next-Generation Sequencing (NGS) platforms and applications. + Experience working within Quality Management Systems (QMS) aligned with ISO 13485, FDA QSR, or IVDR. + Experience with IVD or SaMD product development and regulatory submissions (510(k), PMA, IVDR, etc.). + Familiarity with analytical validation principles including standards (e.g., CLSI guidelines). **Physical Demands** + Primarily office-based role with standard office equipment use. + Prolonged periods of sitting and working at a computer. + Must be able to lift standard office supplies or light equipment if needed. **Training** + All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. **Other** + This position requires periodic travel and some evenings, weekends and/or holidays. + Job may require after-hours response to emergency issues. + At times may be required to work weekends/holidays. **Conditions of Employment:** Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.
    $84k-123k yearly est. 34d ago
  • Translational Scientist - Hybrid

    Carislifesciences 4.4company rating

    Tempe, AZ jobs

    At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary Translational Scientist plays a key role in bridging scientific insight and regulatory requirements for development of Next-generation sequencing (NGS) based in vitro diagnostics (IVDs), with a focus on technical documentation throughout the product life cycle and cross-functional collaboration. This role will support analytical verification and validation activities including but not limited to study designs, sample requirements, protocol and report writing and will ensure those executing study protocols understand the scientific rationale. The Translational Scientist will also serve as a liaison between Product Development and Quality Assurance/Regulatory Affairs to ensure the product development process aligns with applicable regulatory requirements. This position requires strong interpersonal and organizational skills in addition to scientific writing skills and regulatory awareness for supporting regulatory submissions of NGS based companion diagnostics (CDx) devices at Caris. Job Responsibilities Composes scientific and technical documents throughout the product development process through collaboration with cross-functional teams including Product Development, Bioinformatics/Statisticians, Molecular Operations, QA, and RA. Support analytical verification and validation (V&V) studies for oncology-focused IVD assays: Contribute to study design and sample planning. Draft and review V&V protocols and reports. Ensure scientific rigor in data interpretation for analytical performance metrics (e.g., LoD, specificity, precision) Translate complex scientific rationale into clear guidance for execution teams. Participate in cross-functional risk assessments (e.g., FMEA), design reviews and contribute to design control deliverables including design inputs, outputs and traceability. Collaborate with Regulatory Affairs to prepare and review regulatory submissions (e.g., FDA 510(k), PMA, EUA, IVDR), including pre- and post-market documents. Extract, synthesize, and format study results for inclusion in regulatory submission documents. Ensure compliance with applicable regulations including FDA 21 CFR Part 820, ISO 13485, IVDR, and country-specific requirements. Stay up to date with evolving oncology biomarkers, therapeutic targets, and regulatory guidance relevant to oncology diagnostics and companion diagnostics (CDx). Must be tolerant to change, ready to take on new challenges and open to learning new skills. Required Qualifications MS degree in Molecular Biology, Biochemistry, Pharmacology, or a related life sciences field with 5+ years of relevant industry experience; or a PhD with relevant training and experience. Strong scientific writing experience (e.g., validation documents, protocols, SOPs, peer-reviewed publications). Solid understanding of molecular biology principles and assay development processes. Familiarity with Design Control and product development within a regulated (IVD or medical device) environment. Ability to work effectively across interdisciplinary teams and manage multiple priorities. Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working. Knowledge of Internet for business use. Preferred Qualifications Hands-on or scientific knowledge of Next-Generation Sequencing (NGS) platforms and applications. Experience working within Quality Management Systems (QMS) aligned with ISO 13485, FDA QSR, or IVDR. Experience with IVD or SaMD product development and regulatory submissions (510(k), PMA, IVDR, etc.). Familiarity with analytical validation principles including standards (e.g., CLSI guidelines). Physical Demands Primarily office-based role with standard office equipment use. Prolonged periods of sitting and working at a computer. Must be able to lift standard office supplies or light equipment if needed. Training All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other This position requires periodic travel and some evenings, weekends and/or holidays. Job may require after-hours response to emergency issues. At times may be required to work weekends/holidays. Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
    $84k-123k yearly est. Auto-Apply 35d ago
  • Translational Scientist - Hybrid

    Caris Life Sciences 4.4company rating

    Tempe, AZ jobs

    At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary Translational Scientist plays a key role in bridging scientific insight and regulatory requirements for development of Next-generation sequencing (NGS) based in vitro diagnostics (IVDs), with a focus on technical documentation throughout the product life cycle and cross-functional collaboration. This role will support analytical verification and validation activities including but not limited to study designs, sample requirements, protocol and report writing and will ensure those executing study protocols understand the scientific rationale. The Translational Scientist will also serve as a liaison between Product Development and Quality Assurance/Regulatory Affairs to ensure the product development process aligns with applicable regulatory requirements. This position requires strong interpersonal and organizational skills in addition to scientific writing skills and regulatory awareness for supporting regulatory submissions of NGS based companion diagnostics (CDx) devices at Caris. Job Responsibilities Composes scientific and technical documents throughout the product development process through collaboration with cross-functional teams including Product Development, Bioinformatics/Statisticians, Molecular Operations, QA, and RA. Support analytical verification and validation (V&V) studies for oncology-focused IVD assays: Contribute to study design and sample planning. Draft and review V&V protocols and reports. Ensure scientific rigor in data interpretation for analytical performance metrics (e.g., LoD, specificity, precision) Translate complex scientific rationale into clear guidance for execution teams. Participate in cross-functional risk assessments (e.g., FMEA), design reviews and contribute to design control deliverables including design inputs, outputs and traceability. Collaborate with Regulatory Affairs to prepare and review regulatory submissions (e.g., FDA 510(k), PMA, EUA, IVDR), including pre- and post-market documents. Extract, synthesize, and format study results for inclusion in regulatory submission documents. Ensure compliance with applicable regulations including FDA 21 CFR Part 820, ISO 13485, IVDR, and country-specific requirements. Stay up to date with evolving oncology biomarkers, therapeutic targets, and regulatory guidance relevant to oncology diagnostics and companion diagnostics (CDx). Must be tolerant to change, ready to take on new challenges and open to learning new skills. Required Qualifications MS degree in Molecular Biology, Biochemistry, Pharmacology, or a related life sciences field with 5+ years of relevant industry experience; or a PhD with relevant training and experience. Strong scientific writing experience (e.g., validation documents, protocols, SOPs, peer-reviewed publications). Solid understanding of molecular biology principles and assay development processes. Familiarity with Design Control and product development within a regulated (IVD or medical device) environment. Ability to work effectively across interdisciplinary teams and manage multiple priorities. Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working. Knowledge of Internet for business use. Preferred Qualifications Hands-on or scientific knowledge of Next-Generation Sequencing (NGS) platforms and applications. Experience working within Quality Management Systems (QMS) aligned with ISO 13485, FDA QSR, or IVDR. Experience with IVD or SaMD product development and regulatory submissions (510(k), PMA, IVDR, etc.). Familiarity with analytical validation principles including standards (e.g., CLSI guidelines). Physical Demands Primarily office-based role with standard office equipment use. Prolonged periods of sitting and working at a computer. Must be able to lift standard office supplies or light equipment if needed. Training All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other This position requires periodic travel and some evenings, weekends and/or holidays. Job may require after-hours response to emergency issues. At times may be required to work weekends/holidays. Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
    $84k-123k yearly est. 32d ago
  • HS & Behavioral Research Associate II / PRA Kipke Lab / Per Diem

    Childrens Hospital Los Angeles 4.7company rating

    Los Angeles, CA jobs

    NATIONAL LEADERS IN PEDIATRIC CARE Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. It's Work That Matters. Overview This is 100% remote position. CHLA requires a primary residence in California prior to start date. Schedule: Per Diem, Days Purpose Statement/Position Summary: Under the supervision of the Research Associates/Research Managers, recruits project participants and administers structured and/or interview survey materials. May be responsible for data collection, data entry, and/or study documentation. May be responsible for coordinating small research and evaluation projects and staff. Duties are performed with supervision, feedback and guidance from principal investigators. May be responsible for tracking study participants throughout the project life. Minimum Qualifications/Work Experience: 2+ years of qualitative and/or quantitative interviewing experience required. * Experience using CASI interviewing tools preferred. * Experience working with children, youth, and families preferred. * Experience using Microsoft Word, Excel, and Access preferred. Education/Licensure/Certification: High school diploma or equivalent. College education in related discipline preferred. Pay Scale Information USD $44.30 - USD $44.30 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. PRA Kipke Lab
    $52k-73k yearly est. 5d ago
  • AI Scientist

    Absci 4.4company rating

    Remote

    Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci is a global company headquartered in Vancouver, WA, and maintains offices in New York City, Switzerland, and Serbia. Learn more at ************* or follow us on LinkedIn (@absci), X (@Abscibio), and YouTube. About the role Absci is seeking AI Scientists to join its team of experts advancing generative and predictive modeling at the intersection of machine learning and drug discovery. As an AI Scientist, you will develop AI models that generate and evaluate antibody therapeutic candidates. We are looking for exceptional contributors with backgrounds in deep learning, protein design and engineering, natural language processing, computer vision, and molecular dynamics to develop innovative approaches to creating and assessing therapeutic antibodies in silico . Absci's computational teams (including its AI Scientists) develop and validate software platforms for antibody design and in silico assessment, while its Wet Lab teams experimentally validate its AI platforms, and its Drug Creation teams translate experimentally-validated AI designs into clinically-viable therapeutics. The ideal AI Scientist candidate will: Care as much about solving the technical problems related to designing antibody therapeutics as they do about translating solutions to the clinic; Use their expertise to influence the AI team's research agenda while maintaining high levels of responsibility and accountability for their work; Demonstrate their curiosity about the problems we are attempting to solve by developing proficiency in disciplines that fall outside their own areas of expertise, constantly increasing the scale and impact of their contributions; Invest in ensuring their work is accessible and interpretable to scientists with other domain expertise. Why Absci's AI team? Absci offers AI Scientists a unique opportunity to not only develop novel, cutting edge machine learning models, but also apply these models in real-time to generate candidate antibody therapeutics. In particular: Absci provides its AI Scientists with access to industry-leading compute resources, enabling large-scale experimentation for model training and deployment. Absci maintains its own Wet Lab, enabling AI Scientists to validate novel modeling methods via both in silico and in vitro experimentation. Absci maintains and is growing its own internal pipeline of assets, enabling AI Scientists to see their work directly translated into therapeutic impact for patients. This position can be remote, hybrid, or onsite in New York, NY or Vancouver, WA. Key Responsibilities Develop state-of-the-art deep learning models for structure-based antibody design, antibody sequence design, antibody-antigen co-folding, antibody-antigen binding prediction, and physics-based antibody design and evaluation Partner with teammates in AI Research, Platform Engineering, and Computational Biology to identify key challenges and design innovative, AI-driven solutions Analyze in silico and in vitro validation results to iteratively improve design and evaluation methodologies Deliver and publish high-impact research that advances Absci's position as a thought leader in the field of AI antibody design Qualifications PhD or equivalent experience in Machine Learning, Computer Science, Computational Biology, Computational Chemistry, Biophysics, or a related field 3+ years of research experience at the intersection of machine learning and protein design, molecular modeling, or a related field, ideally including industry experience Fluency in Python and PyTorch Comfortable with design, implementation, and evaluation of state-of-the-art AI algorithms for protein design and protein structure prediction Expertise in large-scale model training Demonstrated ability to work collaboratively in an ambitious, fast-paced, interdisciplinary environment Demonstrated experience presenting complex technical work to diverse audiences Strong publication record in respected, high-impact journals and conferences Absci's AI team does not accept and is not responsible for fees related to unsolicited agency resumes. Compensation and Benefits The base salary range for this position is $160,000- $260,000. The range provided is based on what we believe is a reasonable estimate for the base salary range for this job at the time of posting. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. Absci offers highly competitive salaries and benefits including medical, dental, and vision insurance, unlimited vacation, parental leave, employee assistance programs, voluntary life and disability insurance, annual bonus potential, the ability to participate in our employee stock purchase plan, a 401(k) with a generous company match, and so much more. Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, sexual orientation, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, marital status, or any characteristic protected under applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should request the recruiter or hiring manager or contact ****************.
    $78k-120k yearly est. Auto-Apply 60d+ ago
  • Modern AI Scientist

    Healthcare Services 4.1company rating

    Remote

    Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: AI Scientist - Modern AI Applications 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You'll Make in this Role As a Principal AI Scientist with deep expertise in Agentic AI, Generative AI, and Natural Language Understanding (NLU), you will lead high-impact technical innovation in HIS applications. In this role, you will be a hands-on research and development leader - driving technical breakthroughs, designing novel AI architectures, and directly influencing the integration of advanced AI into mission-critical healthcare products. You will collaborate closely with other scientists, engineers, and domain experts to create solutions that are explainable, reliable, and transformative for healthcare operations. Key Responsibilities Research & Innovation Design, prototype, and evaluate novel AI models for autonomous, agent-based systems in healthcare workflows. Advance state-of-the-art NLU for clinical, operational, and administrative healthcare text. Explore and implement new capabilities in reasoning, decision-making, and multi-modal understanding. Healthcare-Focused AI Development Adapt and fine-tune large language models to handle healthcare-specific language, regulatory requirements, and ethical considerations. Create AI pipelines that can process structured and unstructured healthcare data (FHIR, HL7, clinical notes, claims data). Contribute to domain-specific model architectures that improve clinical decision-making, revenue cycle management, and patient engagement. Technical Leadership Serve as the primary technical authority on Agentic and Generative AI within project teams. Mentor junior AI scientists and engineers through code reviews, research guidance, and technical workshops. Drive internal knowledge-sharing on emerging AI trends, frameworks, and best practices. Operational & Compliance Excellence Implement rigorous model evaluation frameworks for accuracy, robustness, and fairness. Ensure compliance with healthcare privacy and data security regulations (HIPAA, HITRUST). Partner with engineering to move research prototypes into production environments. Required Qualifications Master's in Computer Science, AI, Machine Learning, or related field AND 5+ years of experience in AI/ML, with a strong portfolio of deployed models. Or PhD in Computer Science, AI, Machine Learning, or related field AND 3+ years of experience in AI/ML, with a strong portfolio of deployed models. Experience in Python, R, and modern ML libraries. Experience with GenAI, LLMs, and transformer architectures. Experience with AI development tools and frameworks (PyTorch, TensorFlow, Hugging Face, LangChain, RAG systems). Preferred Skills Multi-modal AI research experience (text, image, structured data). Knowledge graph integration and symbolic reasoning expertise. Proven ability to take AI research from concept to production. Hands-on experience with autonomous AI agents and reasoning systems. Strong track record applying AI to healthcare or life sciences use cases. Familiarity with cloud platforms (AWS) and MLOps practices. Work location: US Remote Travel: May include up to 10% domestic Relocation Assistance: Is not authorized Must be legally authorized to work in the country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Onboarding Requirement: To improve the onboarding experience, you will have an opportunity to meet with your manager and other new employees as part of the Solventum new employee orientation. As a result, new employees hired for this position will be required to travel to a designated company location for on-site onboarding during their initial days of employment. Travel arrangements and related expenses will be coordinated and paid for by the company in accordance with its travel policy. Applies to new hires with a start date of October 1st 2025 or later.Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.
    $79k-120k yearly est. Auto-Apply 59d ago
  • Clinical Scientist (Denver, CO local)

    Philips Healthcare 4.7company rating

    Remote

    Job TitleClinical Scientist (Denver, CO local) Job Description Clinical Scientist (Denver, CO local) The Clinical Scientist will support both IGTS and CT Clinical Science Partnerships by leveraging your clinical and technical expertise to drive innovation, research collaborations, and evidence generation. Your work will focus on advancing minimally invasive and diagnostic procedures, with primary support provided to local Denver area sites. Your role: Identify new customer needs and drive collaborative innovation with clinical and research partners to enhance diagnosis, treatment, and care methods, supporting both CT and IGTS businesses. Lead and contribute to the development of clinical prototypes, strategic innovation roadmaps, and overall business strategy for the CT and IGTS teams. Collaborate with clinical experts, execute feasibility studies, and engage in research collaborations to demonstrate the value of new technologies. Maintain and expand a network of Key Opinion Leaders (KOLs) and stakeholders to support ideation, feasibility studies, and the adoption of novel clinical solutions. Stay current on clinical, regulatory, and market trends, and communicate clinical strategy and value propositions to internal and external audiences. You're the right fit if: You've acquired 2+ years of experience interacting with clinical partners and clinical research, and have strong expertise in clinical investigations, especially in a hospital setting. Your skills include a strong clinical background, preferably in Angiography, CT, or similar imagining modality; knowledge of image-guided interventional procedures and innovations across cardiology, radiology, and/or surgery; and excellent interpersonal skills to work cross-functionally with other key internal and external stakeholders. You have an MD/PhD in biomedical sciences/engineering, or a related discipline. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You're a self-learner, customer-oriented, and enthusiastic about exploring new technologies and solutions with a demonstrated ability to multi-task and transition from micro-to macro level focus. Ability to travel to hospitals and medical congresses as needed. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a field-based role with an onsite presence expected at the University of Denver and other local locations as needed. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in CO is $101,250 to $162,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Denver, CO. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
    $101.3k-162k yearly Auto-Apply 32d ago
  • Clinical Genomics Scientist, Oncology

    Billiontoone 4.1company rating

    Remote

    Ready to redefine what's possible in molecular diagnostics? Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At BillionToOne, we've built something extraordinary-a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today. Our people are our greatest asset: talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion-every innovation you contribute helps remove fear of unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help build the future of precision medicine, this is where you belong. BillionToOne is looking for a Clinical Genomics Scientist, Oncology to help drive somatic mutation variant interpretation and reporting. BillionToOne has recently launched two oncology liquid biopsy products: Northstar Select™ and Northstar Response™ for late-stage solid-tumor cancer patients. Northstar Select™ is a comprehensive pan-cancer somatic mutation profiling panel. Northstar Response™ is a methylation-based, tissue-agnostic treatment response monitoring assay. As a member of the oncology clinical genomics team, you are responsible for helping with day-to-day commercial reporting operations, including variant interpretation and report drafting. Working closely with the medical team, you will develop interpretation and reporting policies based on the latest publications and guidelines, and help scale-up our ever growing reporting needs. This role will report to the Senior Manager of Clinical Genomics, Oncology in a remote-based position or at our Menlo Park location. If you have a strong commitment to improving patient care through clear clinical reporting, have experience in somatic variant interpretation and report drafting, enjoy digging into the technical side of the data alongside bioinformatics, and thrive in a fast-paced entrepreneurial environment, this could be a perfect opportunity for you. Responsibilities: Somatic variant interpretation and data review: Perform somatic-based variant interpretation, diving into the literature and databases to classify variants and match treatments for reporting, performing verification as required with BAM file analysis. Clinical report drafting: Carefully draft reports for each requisition primarily using in-house reporting API, working closely with the engineering and QA teams on reporting, and the laboratory directors on report language. Somatic mutation interpretation and reporting policy development: Work closely with lab directors, R&D, medical, and other related functions to develop and modify the somatic interpretation SOPs in accordance with ACMG/AMP guidelines, and the latest published literature. Content curation: Contribute to curation of gene-level content such as domain and critical residue curation.Molecular tumor board: Serve as a subject matter expert in consulting with the medical science liaison team, and presenting in molecular tumor boards to facilitate knowledge sharing. Contribute to oncology R&D: Work closely with the R&D team to help with somatic oncology based projects, providing expertise on variant interpretation, biological pathways/mechanisms, and other gene/variant-level reviews and analyses. Qualifications: Ph.D. in Human Genetics, M.S. in Genetic Counseling, or related field 2+ years of experience in somatic variant interpretation based on ACMG/AMP guidelines in a clinical setting (alternatively, 1+ years of germline variant interpretation and 1+ years of somatic variant interpretation experience) Hands-on experience working with human mutation databases (COSMIC, ClinVar, OncoKB), functional annotation sources (db SNP), and genome browsers (UCSC) Familiarity with IGV and BAM file analysis and data-minded willingness to learn to use basic bioinformatics tools, with technically minded insights Knowledge of cancer somatic mutation and signaling pathways (e.g., which mutations have FDA approved drugs, Phase II/III clinical trials, which mutations are considered “hot targets” for drug development, etc.) Exceptional attention to detail to follow highly detailed SOPs and strong organizational skills to track and manage clinical reporting and product improvement projects Excellent communication skills and ability to work collaboratively with cross-functional teams Operationally-defined flexible schedule, including weekends, as dictated by clinical reporting needs Benefits And Perks: Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients Open, transparent culture that includes weekly Town Hall meetings The ability to indirectly or directly change the lives of hundreds of thousands patients Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80% Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%) Supplemental fertility benefits coverage Retirement savings program including a 4% Company match Increase paid time off with increased tenure Latest and greatest hardware (laptop, lab equipment, facilities) At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses), (2) generous equity options offering, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.). For this position, we offer a total compensation package of $227,473 per year, including a base pay range of $158,401 - $179,521 per year. BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. For more information about how we protect your information, we encourage you to review our Privacy Policy. About BillionToOne BillionToOne is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our revolutionary QCT molecular counting technology enhances disease detection resolution by over a thousandfold using cell-free DNA-a breakthrough that's already transformed the lives of over half a million patients worldwide. Our Impact: We've pioneered game-changing diagnostic solutions that are redefining industry standards. Unity Complete™ stands as the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. In oncology, our Northstar liquid biopsy test uniquely combines treatment selection with real-time monitoring, giving oncologists unprecedented precision in cancer care. Our Growth: From $0 to $125 million in Annual Recurring Revenue in just four years. We've raised close to $400 million in funding, including a $130 million Series D round in June 2024, achieving a valuation of over $1 billion. This backing comes from world-class investors including Hummingbird, Adams Street Partners, Neuberger Berman, Baillie Gifford, and Premji Invest. Our Recognition: Forbes recently named us one of America's Best Startup Employers for 2025, and we were awarded Great Place to Work certification in 2024-with an incredible 100% of our people reporting they are willing to give extra to get the job done. These honors recognize not just our innovation but the exceptional culture we've cultivated-one that remains authentically collaborative and transparent even as we've scaled. Our Future: Headquartered in Menlo Park with facilities in Union City, California, we're continuing to push the boundaries of what's possible in molecular diagnostics. Recent clinical outcomes data for Unity Fetal Risk Screen and new advances in cancer diagnostics prove we're just getting started. At BillionToOne, you'll join a diverse team of passionate innovators who believe that the best science happens when brilliant minds collaborate openly, think boldly, and never lose sight of the patients whose lives depend on our work. Ready to help us change the world, one diagnosis at a time? Learn more at ********************
    $158.4k-179.5k yearly Auto-Apply 51d ago
  • Cytogenetic Scientist I

    Sentara Healthcare 4.9company rating

    Virginia Beach, VA jobs

    City/State Virginia Beach, VA Work Shift First (Days) Sentara Health is hiring a Cytogenetic Scientist to work full-time day shifts (6a-230p) in Cytogenetics Lab. is on-site at the Sentara Cytogenetics Laboratory in Virginia Beach, VA. Sign on bonus up to $20,000 for qualified candidates! As a Cytogenetic Scientist , duties are to perform laboratory tests; interprets results; documents and reports results. Maintains department equipment, instruments, and tools. Requires critical thinking skills. Demonstrates general knowledge of chromosome disorders. Education * Bachelor's Degree Certification/Licensure * ASCP-CG (required) Experience * Cytogenetics experience (preferred) keyword: laboratory services, Talroo-Allied Health, cytogenetics Benefits: Caring For Your Family and Your Career * Medical, Dental, Vision plans * Adoption, Fertility and Surrogacy Reimbursement up to $10,000 * Paid Time Off and Sick Leave * Paid Parental & Family Caregiver Leave * Emergency Backup Care * Long-Term, Short-Term Disability, and Critical Illness plans * Life Insurance * 401k/403B with Employer Match * Tuition Assistance - $5,250/year and discounted educational opportunities through Guild Education * Student Debt Pay Down - $10,000 * Reimbursement for certifications and free access to complete CEUs and professional development * Pet Insurance * Legal Resources Plan * Colleagues have the opportunity to earn an annual discretionary bonus if established system and employee eligibility criteria is met. Sentara Health is an equal opportunity employer and prides itself on the diversity and inclusiveness of its close to an almost 30,000-member workforce. Diversity, inclusion, and belonging is a guiding principle of the organization to ensure its workforce reflects the communities it serves. In support of our mission "to improve health every day," this is a tobacco-free environment. For positions that are available as remote work, Sentara Health employs associates in the following states: Alabama, Delaware, Florida, Georgia, Idaho, Indiana, Kansas, Louisiana, Maine, Maryland, Minnesota, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
    $52k-76k yearly est. Auto-Apply 5d ago
  • Cytogenetic Scientist I

    Sentara Healthcare 4.9company rating

    Virginia jobs

    City/State Virginia Beach, VA Work Shift First (Days) Sentara Health is hiring a Cytogenetic Scientist to work full-time day shifts (6a-230p) in Cytogenetics Lab. is on-site at the Sentara Cytogenetics Laboratory in Virginia Beach, VA. Sign on bonus up to $20,000 for qualified candidates! As a Cytogenetic Scientist , duties are to perform laboratory tests; interprets results; documents and reports results. Maintains department equipment, instruments, and tools. Requires critical thinking skills. Demonstrates general knowledge of chromosome disorders. Education Bachelor's Degree Certification/Licensure ASCP-CG (required) Experience Cytogenetics experience (preferred) keyword: laboratory services, Talroo-Allied Health, cytogenetics Benefits: Caring For Your Family and Your Career• Medical, Dental, Vision plans• Adoption, Fertility and Surrogacy Reimbursement up to $10,000• Paid Time Off and Sick Leave• Paid Parental & Family Caregiver Leave • Emergency Backup Care• Long-Term, Short-Term Disability, and Critical Illness plans• Life Insurance• 401k/403B with Employer Match• Tuition Assistance - $5,250/year and discounted educational opportunities through Guild Education• Student Debt Pay Down - $10,000• Reimbursement for certifications and free access to complete CEUs and professional development•Pet Insurance •Legal Resources Plan •Colleagues have the opportunity to earn an annual discretionary bonus if established system and employee eligibility criteria is met. Sentara Health is an equal opportunity employer and prides itself on the diversity and inclusiveness of its close to an almost 30,000-member workforce. Diversity, inclusion, and belonging is a guiding principle of the organization to ensure its workforce reflects the communities it serves. In support of our mission “to improve health every day,” this is a tobacco-free environment. For positions that are available as remote work, Sentara Health employs associates in the following states: Alabama, Delaware, Florida, Georgia, Idaho, Indiana, Kansas, Louisiana, Maine, Maryland, Minnesota, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
    $52k-76k yearly est. Auto-Apply 7d ago
  • Principal Research Associate, Analytical Development

    Moderna 4.8company rating

    Norwood, MA jobs

    The Role: Reporting to the Head of the Product Characterization group, the individual in this role will coordinates characterization and comparability studies to support advancement of Moderna's pipeline, including commercial products. The incumbent should be familiar and have hands-on experience with most of the routine biochemical and biophysical characterization techniques used for RNA structural characterization, including mass spectrometry, spectroscopy, calorimetry, liquid chromatography, ELISA, light scattering and next generation sequencing. Demonstrated writing skills are required for protocol drafting and report compilation. Polished communication skills are essential considering that the incumbent will regularly interact with other RAs and Scientists within the Analytical Development, Analytical Technical Operations and Process Development teams. The individual will present scientific findings/results internally or externally. The individual will also evaluate new technologies, optimize methods and write methods SOPs. Here's What You'll Do: Draft testing protocols and compile characterization reports in support of regulatory filings Coordinate sample generation and sample submissions for partner groups Execute testing for various characterization assays including calorimetry, spectroscopy, light scattering and next generation sequencing Perform data analysis and data trending utilizing good documentation practices Record and communicate findings, present results at internal or cross-functional meetings Write/Revise SOPs related to job function Collaborate with other members within the with R&D departments throughout the company Perform general laboratory support activities including equipment maintenance and housekeeping Be accountable for project success and results delivery Here's What You'll Bring to the Table: BS with at least 4 years of industry experience, or MS with at least 2 years of industry experience (Biophysics, Chromatography, Biochemistry, Molecular Biology, or related science), Experience in performing biophysical characterization with focus on mRNA structural characterization Experience with spectroscopy and calorimetry Excellent writing and documentation skills Excellent interpersonal and collaborative skills Ability to work independently and effectively in a highly dynamic environment This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work. At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 -
    $89.9k-143.8k yearly Auto-Apply 60d+ ago
  • Research Scientist ll

    Health Research, Inc. 4.5company rating

    Menands, NY jobs

    Applications to be submitted by January 27, 2026 Compensation Grade: P22 Compensation Details: Minimum: $81,696. 00 - Maximum: $81,696. 00 Annually Positions with a designated work location in New York City, Nassau, Rockland, Suffolk, or Westchester Counties will receive a $4,000 annual downstate adjustment (pro-rated for part-time positions). Department (OPH) CCH - Division of Chronic Disease Prevention - Bureau of Cancer Epidemiology Job Description: Responsibilities Health Research, Inc. is seeking a Research Scientist II to work as part of the Bureau of Cancer Epidemiology's analysis and output unit. The incumbent will be responsible for data analysis using New York State Cancer Registry (NYSCR) data and linked data sources to improve understanding of cancer patterns in NYS. The incumbent will participate in research and evaluation projects using NYSCR data, including the design, analysis, interpretation, and presentation of findings. Research and evaluation projects will address multiple aspects of cancer epidemiology including incidence, stage at diagnosis, treatment, survival, and mortality. The incumbent will also interact with external researchers to provide guidance regarding use of NYSCR data for research and to collaborate on approved projects. Specific tasks will include conducting data linkages, contributing to quality improvement activities including machine learning projects, contributing to annual calls-for-data and other deliverables, and contributing to internal and external research and evaluation projects. Other appropriate related duties as assigned. Minimum Qualifications Bachelor's degree in Public Health, Epidemiology, Data Science, Biostatistics, or a related field and three years of research experience; OR a Master's degree in a related field and two years of research experience; or a Doctorate in a related field. Preferred Qualifications Master's degree in Public Health or a related field. Proficiency in data analysis and interpretation of analysis results. Proficiency using statistical programming and database software such as SAS, R, and SQL. Experience analyzing large public health data files. Experience in cancer surveillance and knowledge of cancer registry standards and operations. Familiarity and experience with machine learning and natural language processing algorithms. Demonstrated excellent oral and written communication skills. Conditions of Employment Grant funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables, is required. Visa sponsorship may be available for this position, in accordance with applicable federal requirements. The selected candidate must reside within a reasonable commuting distance of the official work location specified in the job posting and must also be located in or willing to relocate to one of the following states: New York, New Jersey, Connecticut, Vermont, or Massachusetts, prior to hire. This position is eligible for a hybrid work schedule, with a combination of onsite and remote work. HRI participates in the E-Verify Program. Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans www. healthresearch. org About Health Research, Inc. Join us in our mission to make a difference in public health and advance scientific research! At Health Research, Inc. (HRI), your work will contribute to meaningful change and innovation in the communities we serve! At HRI, we are on a mission to transform the health and well-being of the people of New York State through innovative partnerships and cutting-edge public health initiatives. As a dynamic non-profit organization, HRI plays a crucial role in advancing the strategic goals of the New York State Department of Health (DOH), Roswell Park Comprehensive Cancer Center (RPCCC), and other health-related entities. HRI offers a robust, comprehensive benefits package to eligible employees, including: Health, dental and vision insurance - Several comprehensive health insurance plans to choose from; Flexible benefit accounts - Medical, dependent care, adoption assistance, parking and transit; Generous paid time off - Paid federal and state holidays, paid sick, vacation and personal leave; Tuition support - Assistance is available for individuals pursuing educational or training opportunities; Retirement Benefits - HRI is a participating employer in the New York State and Local Retirement System and offers optional enrollment in the New York State Deferred Compensation Plan. HRI provides a postretirement Health Benefits Plan for qualified retirees to use towards health insurance premiums and eligible medical expenses; Employee Assistance Program - Provides educational and wellness programs, training, and 24/7 confidential services to assist employees, both personally and professionally; And so much more! As the Executive Director of Health Research, Inc. (HRI), I would like to welcome you to HRI's career page. HRI's mission is to build a healthier future for New York State and beyond through the delivery of funding and program support to further public health and research programs in support of the New York State Department of Health, Roswell Park Comprehensive Cancer Center and other entities. This achievement is made possible through the recruitment of highly talented and qualified individuals. As an Equal Opportunity and Affirmative Action employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, age, disability, protected veteran status, or any other characteristic protected by law. HRI is committed to fostering an environment that encourages collaboration, innovation, and mutual respect and we strive to ensure every individual feels welcomed and appreciated. We invite you to explore and apply for any open positions that align with your interests. --- If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to access job openings or apply for a job on this site as a result of your disability. You can request reasonable accommodations by contacting HRI Human Resources at hrihr@healthresearch. org or **************.
    $81.7k yearly Auto-Apply 9d ago
  • Research Scientist ll

    Health Research, Inc. 4.5company rating

    Menands, NY jobs

    Applications to be submitted by January 27, 2026 Compensation Grade: P22 Compensation Details: Minimum: $81,696.00 - Maximum: $81,696.00 Annually Positions with a designated work location in New York City, Nassau, Rockland, Suffolk, or Westchester Counties will receive a $4,000 annual downstate adjustment (pro-rated for part-time positions). Department (OPH) CCH - Division of Chronic Disease Prevention - Bureau of Cancer Epidemiology Job Description: Responsibilities Health Research, Inc. is seeking a Research Scientist II to work as part of the Bureau of Cancer Epidemiology's analysis and output unit. The incumbent will be responsible for data analysis using New York State Cancer Registry (NYSCR) data and linked data sources to improve understanding of cancer patterns in NYS. The incumbent will participate in research and evaluation projects using NYSCR data, including the design, analysis, interpretation, and presentation of findings. Research and evaluation projects will address multiple aspects of cancer epidemiology including incidence, stage at diagnosis, treatment, survival, and mortality. The incumbent will also interact with external researchers to provide guidance regarding use of NYSCR data for research and to collaborate on approved projects. Specific tasks will include conducting data linkages, contributing to quality improvement activities including machine learning projects, contributing to annual calls-for-data and other deliverables, and contributing to internal and external research and evaluation projects. Other appropriate related duties as assigned. Minimum Qualifications Bachelor's degree in Public Health, Epidemiology, Data Science, Biostatistics, or a related field and three years of research experience; OR a Master's degree in a related field and two years of research experience; or a Doctorate in a related field. Preferred Qualifications Master's degree in Public Health or a related field. Proficiency in data analysis and interpretation of analysis results. Proficiency using statistical programming and database software such as SAS, R, and SQL. Experience analyzing large public health data files. Experience in cancer surveillance and knowledge of cancer registry standards and operations. Familiarity and experience with machine learning and natural language processing algorithms. Demonstrated excellent oral and written communication skills. Conditions of Employment Grant funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables, is required. Visa sponsorship may be available for this position, in accordance with applicable federal requirements. The selected candidate must reside within a reasonable commuting distance of the official work location specified in the job posting and must also be located in or willing to relocate to one of the following states: New York, New Jersey, Connecticut, Vermont, or Massachusetts, prior to hire. This position is eligible for a hybrid work schedule, with a combination of onsite and remote work. HRI participates in the E-Verify Program. Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans ********************** About Health Research, Inc. Join us in our mission to make a difference in public health and advance scientific research! At Health Research, Inc. (HRI), your work will contribute to meaningful change and innovation in the communities we serve! At HRI, we are on a mission to transform the health and well-being of the people of New York State through innovative partnerships and cutting-edge public health initiatives. As a dynamic non-profit organization, HRI plays a crucial role in advancing the strategic goals of the New York State Department of Health (DOH), Roswell Park Comprehensive Cancer Center (RPCCC), and other health-related entities. HRI offers a robust, comprehensive benefits package to eligible employees, including: Health, dental and vision insurance - Several comprehensive health insurance plans to choose from; Flexible benefit accounts - Medical, dependent care, adoption assistance, parking and transit; Generous paid time off - Paid federal and state holidays, paid sick, vacation and personal leave; Tuition support - Assistance is available for individuals pursuing educational or training opportunities; Retirement Benefits - HRI is a participating employer in the New York State and Local Retirement System and offers optional enrollment in the New York State Deferred Compensation Plan. HRI provides a postretirement Health Benefits Plan for qualified retirees to use towards health insurance premiums and eligible medical expenses; Employee Assistance Program - Provides educational and wellness programs, training, and 24/7 confidential services to assist employees, both personally and professionally; And so much more!
    $81.7k yearly Auto-Apply 10d ago
  • R&D Test Technician

    Ferno EMS 3.9company rating

    Wilmington, OH jobs

    Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES Support R&D programs by performing broad spectrum V&V activities. Responsible for routine and administrative tasks. Responsible for maintaining a clean and safe environment. Responsible to project teams as a subject matter expert in electro-mechanical verification and validation of medical devices. Lead communication and provide issue escalation support to project teams. Responsible for conducting physical, electrical and functional evaluations of products. Develop detailed test plans for devices under test. Collection of complex data streams using standard and custom instrumentation. Data analysis and presentation using spreadsheets, programming, and statistical software. Research literature to justify test parameters and evaluate designs. Author test reports in compliance with company standards and procedures. Implement established and new processes and procedures under supervision. Coordinate with contract test labs for test scheduling, methods, acceptance criteria, results analyses and reporting. Attend offsite testing to witness and assist. Responsible for developing new test methodologies to best verify and validate both on-market products and R&D prototypes. Regularly troubleshoot, diagnose, and repair existing test equipment. Design and modify fixtures to aid in testing. Work with engineering, quality and regulatory to ensure products maintain certification to applicable standards. Ability to quickly gain an understanding of these standards. Read and analyze engineering drawings, interpret professional journals, technical procedures, and government standards and regulations. Exercise judgment within defined processes and procedures on moderately complex issues. Thorough understanding of processes and procedures within job function and working knowledge across other functions. Provide verbal and written communications subject to peer and management review. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Basic Competency with Microsoft Office Applications and CAD modeling/design capabilities (mechanical and electrical). Experience with SolidWorks and Altium as well as other technical software tools is a plus. Proficiency, hands-on experience and trouble-shooting skills with equipment pertinent to job function (i.e. electro-mechanical systems, computer systems, instrumentation, various testing equipment, PLCs, data acquisition systems, hand and power tools, machining equipment, etc.). Mechatronics and/or electro-mechanical test lab experience is a plus. Knowledge and/or experience with machining, metal working and fabrication is a plus. Enjoy a shop/lab setting requiring hands-on functions. Track record of test activities accountable to business or customers for program success is a plus. Exposure to and/or basic engineering understanding of design principles related to mechanical and electrical assemblies, electro-mechanical/hydraulic devices, motors, control systems, test equipment, data collection, instrumentation and calibration. Exposure and/or basic understanding of medical devices is a plus. TRAINING REQUIREMENTS FERNO Quality Management System (QMS) training applicable to position OSHA training EDUCATION and/or EXPERIENCE Associate's degree (A.A.) in Mechanical Engineering Technology, Mechatronics or equivalent from a two-year or technical school or two plus years related experience. Equivalent combination of education and experience considered. COMMUNICATION SKILLS Ability to read, analyze and interpret engineering drawings, general business periodicals, professional journals, technical procedures and government regulations. Ability to write technical documentation, procedural manuals and business correspondence. Ability to effectively present information and respond to questions from groups, managers, clients, and customers. MATHEMATICAL SKILLS Ability to work with mathematical concepts, fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. REASONING ABILITY Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagrammatic, or scheduled formats. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Manual labor will constitute up to 50% of role. This position requires the employee to move steel, aluminum, device components, etc., from tables and processing equipment. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 50 pounds and occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work area may be loud. Use of eye, hearing and other personal protective equipment as required. Ferno is an equal opportunity employer and that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.
    $55k-82k yearly est. 45d ago
  • Pharmacovigilance Scientist

    Axsome Therapeutics 3.6company rating

    Day, NY jobs

    Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Pharmacovigilance Scientist to establish and execute pharmacovigilance (PV) systems and procedures, with a strong focus on maintaining high-quality standards. This role is responsible for supporting the Pharmacovigilance (PV) Science function under the guidance of the PV physician and providing oversight of ICSR assessment, signal detection, medical surveillance and risk management activities for investigational products in clinical development and marketed products. This position collaborates with key internal stakeholders, including Clinical Development, Commercial, Medical Information, Medical Affairs, Quality, Regulatory and Legal, as well as multiple external Service Providers and partners on pharmacovigilance-related matters. This position reports to Executive Director of Pharmacovigilance/Drug Safety and is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following: Assist safety physician to enhance safety surveillance and signal detection by monitoring and analyzing safety data from various sources to identify potential safety signals or trends related to investigational and marketed products Contribute to the creation and execution of risk minimization measures to mitigate identified risks. Support the preparation pharmacovigilance aggregate safety reports (e.g., PADER, PSURs, DSURs) to regulatory authorities to meet compliance requirements. Collaborate with PV physician/PV operations and key stakeholders to request/receive applicable sections of the report Provide training and guidance to other functions to address ad hoc questions and issues Ensure timely finalization of the reports to meet the submission timelines of relevant health authorities and other external stakeholders Collaborate and communicate with cross-functional teams to ensure effective safety monitoring and communication Support the safety review team (SRT) and coordinates all safety topic discussion and documentation. Ensure appropriate stakeholder representation and input at SRT Ensure all data is appropriately compiled and presented at SRT for team review Liaise with SRT chair to facilitate communication and support for decisions resulting from the SRT (e.g. update of RMPs, labeling, regulatory notifications etc.) Contribute to clinical trials by providing safety input and reviewing documents such as Clinical Study Reports (CSRs), protocols, and investigator brochures (IB), ICF etc. Provide support for the processing of individual case safety reports (ICSRs) and ensure data accuracy and completeness for investigational and marketed products Support the PV SOP updates Oversee vendor safety process, e.g., signal detection, validation and assessment. Participate in audit/inspection preparedness activities and provide support during regulatory inspections in collaboration with team members Participate in new study initiation to ensure PV requirements are met including but not limited to safety reporting, query resolution, SAR reconciliation, un-blinding process, and safety reporting training Evaluate and improve current PV processes, as needed, to strengthen medical surveillance and risk management process ensuring alignment with best practices Requirements / Qualifications Master's degree in health-discipline or equivalent required, RN, R.Ph, or Pharm D degree is highly preferred 5+ years of progressively responsible Pharmacovigilance experience in a pharmaceutical, biotechnology, or related environment with focused experience in signal detection, safety surveillance, risk mitigation and risk management Extensive experience in case processing, regulatory requirements of ICSRs, MedDRA, WHODD, project management Experience in submission activities in both FDA and EU is preferred, but not required Must demonstrate the ability to draft reports, business correspondence, and procedures, and to effectively present information and respond to questions from internal and external stakeholders, both domestic and international Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles. Experience and Knowledge Knowledge of ICH E2B(R2) and (R3) specifications and entry guidance. Knowledge of global pharmacovigilance reporting rules and timelines, including but not limited to Health Canada, FDA and EMA. Knowledge of relevant food and drug administration (FDA), European union (EU) and international conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance. Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc. Experience with clinical and/or post-marketing case assessment, including medical terminologies, MedDRA and WHO DD coding and narrative writing. Experience with safety database is required; ARISg is a plus but not mandatory. Experience with Veeva is a plus but not mandatory. Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects Excellent verbal and written communication and skills Excellent in detailed-oriented tasks. Salary & Benefits The anticipated salary range for this role is $150,000 - $185,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
    $150k-185k yearly Auto-Apply 60d ago
  • Research Associate - Preclinical Medical Imaging

    Cleveland Clinic 4.7company rating

    Cleveland, OH jobs

    The Small Animal Imaging Core (SAIC), in Shared Laboratory Resources, is seeking a Research Associate who will support areas of preclinical multimodal imaging (e.g. MRI, CT, PET, bioluminescence, etc) for research. The successful applicant will have strong knowledge and research background in medical imaging (e.g MRI/MRS, CT, PET, 2D optical, etc), experience in programming languages (e.g., MATLAB, Python, AFNI, 3D Slicer, etc), and expertise in imaging processing & analysis. They will report to the SAIC Core Director and will be responsible for reporting progress to the PI on imaging experiments and data analysis. Examples of investigator research interests include but are not limited to: Cancer, Heart & Vascular, Inflammation, Neurological & Vision Major Duties/Responsibilities: * Support and collaborate with internal and external researchers on related projects that involve imaging. * Develop foundational imaging acquisition pipelines and imaging research capabilities for various research projects in areas of e.g. neurological disease, cancer biology, cardiovascular disease, etc. * Develop efficient computing algorithms and integrate, implement, and deploy image data processing and analyses workflows for the facility and research labs. * Write peer reviewed papers and technical reports. * Participate in conferences and contribute to facility and PI grant proposal development. Basic Qualifications: * Ph.D. in Biomedical Engineering, Biology, Biochemistry, Biophysics or a related field. * Postdoctoral level - requires a minimum of 1 years' experience in a biomedical research laboratory; Research Associate Level - requires a minimum of 5+ years' experience in a biomedical research laboratory; does not include doctoral work experience. * Familiarity with medical clinical/preclinical medical imaging, e.g. metabolic imaging, MRI, PET/CT, perfusion modeling, optical imaging and validation methods * Excellent analytical and problem-solving skills. * Excellent written and oral communication skills. * Ability to work collaboratively in a multidisciplinary research environment. * Basic programming skills; familiarity with medical imaging software's utilized for data processing and image analyses. Preferred Qualifications: * Previous experience working with pre-clinical research models in medical imaging * Previous experience working with radioactive materials * Previous experience with experimental design and grant proposal development * A strong publication record in peer-reviewed journals and conferences. * Motivated self-starter with the ability to work independently and to participate creatively in collaborative research teams across the core. * Ability to function well in a fast-paced research environment, set priorities to accomplish multiple tasks within deadlines, and adapt to ever changing needs Please remember to include a cover letter and CV with your application. Learn more about Cleveland Clinic About Cleveland Clinic Living in Cleveland Take a Tour About Us Cleveland Clinic's vision is to become the best place for care and the best place to work in healthcare. We are committed to providing a safe, stable, and financially fulfilling work environment. Cleveland Clinic is ambitiously investing in growth. Being a physician-led organization means doing what is best for the patients, every day. Cleveland Clinic is one of the world's largest and busiest health centers. Patients come to Cleveland Clinic from all over the world. We offer advanced treatment for all illnesses and disorders of the body. Cleveland Clinic is a nonprofit, multispecialty academic medical center that's recognized in the U.S. and throughout the world for its expertise and care. Cleveland Clinic integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual America's Best Hospitals survey. Among Cleveland Clinic's 80,642 employees worldwide are more than 5,743 salaried physicians and researchers, and 20,166 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,690-bed health system that includes a 173-acre main campus near downtown Cleveland, 23 hospitals, more than 270 outpatient facilities, including locations in northeast Ohio; southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2024, there were 14.1 million total outpatient visits, 333,000 hospital admissions and observations, and 320,000 surgical cases throughout Cleveland Clinic's health system. Patients came for treatment from every state and 185 countries. Our Culture Cleveland Clinic is pleased to be an equal employment opportunity employer. Smoke/drug free environment. Any application submitted without a CV will delay the review process Please be advised that all information entered in your application will only be shared with Cleveland Clinic and will not be distributed to third parties. The salary range displayed in this job posting reflects the anticipated salary range for new physicians hired into full-time (100% FTE) positions. This range is generally aligned with or below the 50th percentile of nationally recognized compensation benchmarks by specialty. A successful candidate's actual compensation will be determined in accordance with fair market value, considering factors such as professional experience, clinical expertise, board certification, work history, and FTE. This stated range excludes the value of Cleveland Clinic's comprehensive benefits package, which includes healthcare, dental, vision, retirement, and other offerings. About the Community Cleveland is part of Northeast Ohio which is composed of six metropolitan areas. Each of them provides affordable real estate, excellent schools, safe communities as well as an abundance of outdoor activities. Find out here how great it is to live in Cleveland! Information for Candidates Candidates will only be asked to provide personal documents once an offer of employment has been made and accepted. Recruitment scams are becoming increasingly common online, with false advertisements and requests for payment or personal details claiming to come from reputable organizations. Please be assured that our physician recruiters will never ask for payment from candidates at any stage of the recruitment or offer process. Disclaimer Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with the program, which will include obtaining an influenza vaccination or an exemption. Pay Range Minimum salary: $66,228 Maximum salary: $80,000
    $66.2k-80k yearly 35d ago

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