Associate Principal Scientist jobs at Generation Bio

We are seeking an experienced and driven Principal Scientist, Drug Product & Analytical Development to participate in late-stage clinical and commercial manufacturing and analytical method development and method validation, serving as a dual role for intranasal drug products. The successful candidate will oversee the development, optimization, and validation of nasal spray-specific analytical methods, manage outsourced manufacturing and testing activities at contract manufacturers (CDMOs), and serve as the drug product/analytical representative on all CMC teams. This individual will also contribute technical expertise across multiple programs, benchmark industry trends, and lead the production of registration batches. This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Senior Vice President, Head of CMC. Key Duties & Responsibilities: Key responsibilities of this role include, but are not limited to: * Provide strategic direction and oversight for drug product development and analytical testing activities. * Represent the Analytical and Drug Product functions on the CMC teams, ensuring alignment with program goals and timelines. * Lead cross-functional initiatives and contribute to departmental strategy and planning. * Ensure timely delivery of technical drug product (nasal spray) milestones, including process development, tech transfer, cGMP production, stability studies, process characterization (QbD), and validation. * Oversee manufacturing of registration batches in alignment with regulatory and quality standards. * Coordinate closely with CMOs for manufacturing and CROs for analytical testing, including onboarding and technical transfer to new vendors. * Lead development and validation of both nasal spray-specific analytical methods as well as general chromatography methods. * Ensure all analytical testing is conducted in compliance with regulatory expectations (ICH, FDA) and internal quality standards. * Provide technical oversight of CRO activities and ensure successful method transfer and implementation. * Serve as a technical resource for strategic decision making, risk assessment, and mitigation planning. * Monitor industry trends and implement innovative technologies to enhance nasal spray drug product development and testing. * Contribute technical expertise across multiple projects and programs, supporting cross-functional collaboration. * Author and review technical documentation, including protocols, reports, test methods, SOPs, and regulatory submissions. * Ensure compliance with GMP and regulatory requirements throughout development and manufacturing processes. Education & Experience * Master's degree in Process Engineering or Pharmaceutical Sciences with 8-10 years of experience within a pharmaceutical or biotechnology company (direct sponsor experience required) OR * Ph.D. in a related field with 5-8 years of experience within a pharmaceutical or biotechnology company (direct sponsor experience required) Qualifications: * Proficiency with typical nasal spray and/or inhalation product performance analytical tools (e.g. Particle Size analysis, Plume Geometry, Spray Pattern, Droplet Size Distribution, Actuation Force, etc.) as well as typical chromatographic analytical tools (e.g. PHLC-UV, LC-MS). * Thorough understanding of ICH, FDA, and other regulatory expectations for method validation, transfer, and GMP manufacturing and analytical testing. * Proficiency with utilizing typical literature searching techniques to solve nasal spray and/or inhalation drug product manufacturing and/or testing problems. * Extensive experience in CMC GMP pharmaceutical development including a proven track record of process scale up and validation. * Extensive experience in working with and outsourcing work to CROs and CMOs. * Advanced Microsoft Word, Excel, and PowerPoint functions. Experience with statistical software such as Jump or Prism. * Creative thinking and problem-solving skills in a standalone, multi-disciplinary environment with accountability for information department or functional strategy. Compensation and Benefits What we offer: * Industry competitive compensation * Performance-based bonuses * Stock options * Employee Stock Purchase Plan * 401k plan * A collaborative and innovative work environment at the forefront of biotech advancements Give your best, live wholesomely: * Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents * FSA and HAS * Basic Life Insurance 2x Earnings and AD&D * Employee Assistance Program * Healthcare advocates group to help navigate the healthcare system Work-life balance: * Unlimited paid time off * Flexible work schedule * Remote work option * Paid holidays * Mental health days * Winter shutdown * Casual work environment We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence. The anticipated salary range for candidates who will work remotely is $160,000-$190,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc. Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents. Physical Demands: The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often. Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. This position requires the ability to lift and/or move up to 25 pounds occasionally. Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment. DISCLAIMER The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification. All Employee's have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA) OVERVIEW OF THE COMPANY Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen's neuroscience pipeline is designed to rapidly activate olfactory system and rain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen's neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at *****************

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.

What you can expect As an AI Scientist specializing in Agentic AI, you will develop intelligent agents that perceive, reason, and act in dynamic environments as part of Zoom AI Companion (AIC). Your work will directly impact the Zoom user experience by designing and implementing novel algorithms and systems. These impact workplace efficiency and customer engagement in Zoom Revenue Accelerator (ZRA), Zoom Customer Experience (ZCX) and Zoom Workplace for numerous domains. About the Team We are part of the Zoom AI Vertical Organization, dedicated to enhancing the Zoom user experience in workplace and customer interactions. Our team of experts is focused on creating the next generation of AI technologies. This technology can understand, learn, and adapt to improve user engagement and satisfaction. We are seeking a talented AI Scientist to join our team and contribute to our groundbreaking Agentic AI project. Responsibilities Conducting cutting-edge research in the field of Agentic AI, focusing on developing autonomous agents that can learn and adapt in complex environments. Designing, implementing, and evaluating novel algorithms for perception, reasoning, decision-making, and learning to improve Zoom's user experience. Developing AI solutions that enhance meeting experiences and enable seamless human-machine natural interactions within Zoom. Applying large language models (LLM) and Agentic AI frameworks to real production scenarios, fundamentally changing how humans communicate and collaborate during work and daily life. Collaborating with cross-functional teams to integrate Agentic AI solutions into Zoom's real-world applications and products. Mentoring and providing guidance to junior researchers and team members. What we're looking for Bachelor's degree in Computer Science, Artificial Intelligence, Machine Learning, Cognitive Science, Data Science, or a related field 5+ years of relevant experience in applied research and/or machine learning Show an understanding of machine learning algorithms, neural networks, reinforcement learning, cognitive architectures, and multi-modality including speech and vision Exhibit development skills in programming languages such as Python, C++, or Java, and experience with AI frameworks and libraries (e.g., PyTorch) Utilize problem-solving skills and the ability to think creatively and critically about complex problems Communicate and collaborate with the ability to work effectively in a team-oriented environment Salary Range or On Target Earnings: Minimum: $143,000.00 Maximum: $312,800.00 In addition to the base salary and/or OTE listed Zoom has a Total Direct Compensation philosophy that takes into consideration; base salary, bonus and equity value. Note: Starting pay will be based on a number of factors and commensurate with qualifications & experience. We also have a location based compensation structure; there may be a different range for candidates in this and other locations. Ways of Working Our structured hybrid approach is centered around our offices and remote work environments. The work style of each role, Hybrid, Remote, or In-Person is indicated in the job description/posting. Benefits As part of our award-winning workplace culture and commitment to delivering happiness, our benefits program offers a variety of perks, benefits, and options to help employees maintain their physical, mental, emotional, and financial health; support work-life balance; and contribute to their community in meaningful ways. Click Learn for more information. About Us Zoomies help people stay connected so they can get more done together. We set out to build the best collaboration platform for the enterprise, and today help people communicate better with products like Zoom Contact Center, Zoom Phone, Zoom Events, Zoom Apps, Zoom Rooms, and Zoom Webinars. We're problem-solvers, working at a fast pace to design solutions with our customers and users in mind. Find room to grow with opportunities to stretch your skills and advance your career in a collaborative, growth-focused environment. Our Commitment At Zoom, we believe great work happens when people feel supported and empowered. We're committed to fair hiring practices that ensure every candidate is evaluated based on skills, experience, and potential. If you require an accommodation during the hiring process, let us know-we're here to support you at every step. We welcome people of different backgrounds, experiences, abilities and perspectives including qualified applicants with arrest and conviction records and any qualified applicants requiring reasonable accommodations in accordance with the law. If you need assistance navigating the interview process due to a medical disability, please submit an Accommodations Request Form and someone from our team will reach out soon. This form is solely for applicants who require an accommodation due to a qualifying medical disability. Non-accommodation-related requests, such as application follow-ups or technical issues, will not be addressed. Think of this opportunity as a marathon, not a sprint! We're building a strong team at Zoom, and we're looking for talented individuals to join us for the long haul. No need to rush your application - take your time to ensure it's a good fit for your career goals. We continuously review applications, so submit yours whenever you're ready to take the next step.

About KariusKarius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide. We are seeking a passionate Clinical Development Scientist who will be responsible for the design and execution of our clinical studies. By working closely with cross-functional teams, you will develop study protocols, analyze data, and generate clinical evidence to support regulatory submissions. The ideal candidate will have a strong background in clinical research and molecular diagnostics with a proven ability to drive study design & implementation in a fast-paced, scientifically rigorous environment. This individual will collaborate closely with external stakeholders including key opinion leaders (KOLs) and Investigators. Provides support for clinical evidence discussions with regulatory agencies, notified bodies, and physician advisory boards. You will communicate across all levels of the organization and need to be able to develop a rapport with indirect or functional leaders to influence decision-making and facilitate change. You will be part of a cross-functional team that includes the medical, clinical, commercial, and product teams as we build future products to solve some of the toughest problems in infectious diseases. Why Should You Join Us?Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company's platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale. Reports to: Sr. Vice President, Clinical Affairs Location: Redwood City, CA (Hybrid) or Remote (USA) Primary Responsibilities• Support the development of clinical protocols, amendments, case report forms and data analysis interpretation.• Conduct secondary research, including literature reviews to support study design.• Assist in the preparation of study reports and other regulatory and/or reimbursement documents.• Collaborate with the trial operations team on execution, and delivery of multiple clinical studies.• Collaborate with biostatistics to develop and execute study statistical analysis plans. • Ensure compliance with relevant regulations, guidelines and SOPs. • Help manage study data and maintain documentation.• Participate in major written deliverables (e.g. protocols, clinical study reports, regulatory submissions, original articles, abstracts, posters and presentation materials) in collaboration with Medical and Clinical Affairs team members.• Support the development of SOPs, policies and work instructions as part of continuous improvement initiatives.• Actively participate in clinical study oversight, including monitoring study progress, ensuring compliance with regulatory requirements, and addressing any clinical issues that arise.• Lead data interpretation sessions and assist in preparing clinical results for publication in peer-reviewed journals or conference presentations.• Support the creation of regulatory documentation and submissions to ensure compliance with FDA and other regulatory bodies. What's Fun About the Job?Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters. Travel: Travel up to 25%. Physical RequirementsSubject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Position Requirements• A minimum of a Master's of Public Health, Ph.D., or MD.• A minimum of 3-5 years of scientific/research background with experience in clinical research (preferably molecular diagnostics) conduct including methodology and statistics.• Experience in scientific and clinical data review and interpretation.Project leadership and management skills. Personal Qualifications• Strong medical writing experience, effective verbal communication, and presentation skills in technical/clinical applications, and experience in the conduct of literature searches pertinent to clinical/medical research.• You possess knowledge of clinical research, device development processes, regulatory requirements, and good clinical and data management practices• Demonstrated ability to thrive in a cross-functional environment focused on company-level goals. DisclaimerThe above is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius. Equal Opportunity EmployerAt Karius, we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees, and are committed to honor and invest in the full diversity of people, in our hiring, recruiting, and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual's race, color, sex, gender identity, and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at *********************** and we will accommodate qualified individuals with disabilities.

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

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 ****************.

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.

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 ********************

Seeking a Fishery Restoration Scientist to support NOAA Fisheries in executing analytical, technical, and field-related tasks across multiple habitat conservation and environmental review programs. This position will work closely with the NOAA Project Lead (PL) to evaluate project impacts, conduct habitat analyses, support regulatory reviews, and develop high-quality technical deliverables. The work will be performed in a fully remote capacity, with only a limited possibility of occasional travel within the east coast regions of Florida, South Carolina, North Carolina, or Georgia. The task includes the following: * Review study objectives developed by the Southeast Region and project partners, identify optimal field study locations, manage partner-provided datasets, develop associated metadata, and recommend practicable refinements to future field efforts. Deliver short technical reports and data files and incorporate all NOAA PL comments into final documentation. * Analyze project-specific data to evaluate compliance with hydropower facility license conditions, with particular attention to fish passage and flow prescriptions. Deliver concise written reports for each facility and revise final documentation in response to NOAA PL comments. * Assess effects to Essential Fish Habitat (EFH) and evaluate proposed mitigative measures for offshore wind energy projects using data provided. Prepare short written reports and develop briefing materials suitable for NOAA senior leadership summarizing project objectives, expected impacts, benefits, and anticipated schedules. Address all NOAA PL comments in final deliverables. * Review dredging operation data and coral condition information for the Port Everglades and Port Miami project areas. Evaluate potential effects to coral habitat, recommend mitigation measures to offset expected impacts, and deliver a written report containing habitat characterizations and supporting GIS files with appropriate metadata and Google Earth files. Address all NOAA PL comments in final documentation. * Conduct EFH, Fish and Wildlife Coordination Act (FWCA), and Fish and Wildlife Planning Assistance (FPA) analyses for proposed construction and restoration projects. Maintain a current understanding of diadromous, estuarine, and reef fish habitats, key environmental pressures, and conservation partnerships across Southeast U.S. watersheds. Use GIS to prepare maps and manage spatial data for analysis, and produce written reports and briefing materials with complete responses to NOAA PL comments. * Submit electronic monthly progress reports that clearly correlate cost, level of effort, activity descriptions, and accomplishments for the reporting period. Requirements * Knowledge of fish and habitat ecology, environmental conservation principles, and habitat impact assessment methodologies. * Experience conducting data analysis, preparing technical summaries, and managing fisheries or environmental datasets. * Experience using GIS software for spatial analysis, map production, and metadata development. * Familiarity with EFH assessments, environmental review processes, and habitat-based conservation strategies within marine or estuarine systems. * Ability to write clear, concise technical reports and prepare briefing materials for senior decision-makers. * Strong proficiency with common software including word processing, spreadsheets, statistical tools, data management applications, and the entire Google suite. * Ability to collaborate with partners, manage multiple ongoing tasks, and respond to technical comments with accuracy and completeness. * Must be a US Citizen or Permanent Resident who has lived in the United States at least 3 of the last 5 years and must be able to pass a background investigation to obtain a security badge to access applicable government systems. Work Location This position is fully remote in support of NOAA Fisheries. Education Bachelor's degree in Biology, Marine Science, Ecology, Environmental Science, or a related discipline, plus three years of experience in fish biology, marine biology, oceanography, or a closely related field. Salary The salary range for this role is $46,000 - 221,000/year. This range is a good faith estimate based on similar roles across the organization. ERT considers several factors when extending an offer of employment, including the location, scope, and associated responsibilities of the specific position, as well as a candidate's work experience, education/training, and key skills. Benefits All full-time employees are eligible to participate in our flexible benefits package, which includes: * Medical, Rx, Dental, and Vision Insurance * 401(k) retirement plan with company-matching * 11 Paid Federal Government Holidays * Paid Time Off (PTO) * Basic Life & Supplemental Life * Health Savings Account, Flexible Spending and Dependent Care Flexible Spending Accounts * Short-Term & Long-Term Disability * Employee assistance program (EAP) * Tuition Reimbursement, Personal Development & Learning Opportunities * Skills Development & Certifications * Professional Membership Reimbursement * Employee Referral Program * Competitive compensation plan * Discretionary variable incentive bonuses based on factors such as individual performance, business unit performance, and/or the company's performance * Publication and Conference Presentation Awards with bonuses ERT is a VEVRAA Federal Contractor and Equal Opportunity employer - All qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status. #LI-Remote

We are seeking a highly experienced and innovative Senior NGS Algorithm Developer to lead the design and optimization of computational pipelines for next-generation sequencing (NGS) data. This role focuses on the detection and interpretation of a wide range of genomic features, including small variants (SNVs/Indels), copy number variants (CNVs), short tandem repeats (STRs), methylation patterns, and variants in homologous and homopolymer regions. Expertise in cancer genomics, somatic variant detection, and secondary analysis of NGS data required. The ideal candidate will hold a Ph.D. in Bioinformatics, Computational Biology, Genomics, or a related field, and have at least 5 years of hands-on experience in algorithm development for NGS applications. Experience in pharmacogenomics (PGx) variant calling, including complex loci such as CYP2D6, is strongly preferred. This role may be performed remotely, hybrid, or onsite, based on candidate preference and business needs. Key Responsibilities Design and implement robust, scalable algorithms for: small variants, CNV detection, STR genotyping, methylation analysis, variant resolution in homologous and homopolymer regions, PGx variant calling, including hybrid alleles and copy number estimation in complex loci (e.g., CYP2D6, TPMT, UGT1A1) Develop and apply algorithms for somatic SNV/Indel calling, CNV and structural variant detection, as well as methylation, alternative splicing, and fusion analysis in cancer transcriptomes Integrate phasing and allele-specific analysis for small variants and methylation Collaborate with assay scientists and software engineers to translate biological requirements into computational solutions Benchmark algorithm performance using public and internal truth sets Maintain reproducible workflows using tools like Nextflow, and Docker Contribute to publications, presentations, and intellectual property development Required Qualifications Ph.D. in Bioinformatics, Computational Biology, Genomics, or a related discipline Minimum 5 years of experience in NGS algorithm development Proficiency in Python, R, C++, and workflow orchestration tools Deep understanding of: Read alignment and variant calling (e.g., BWA-MEM, minimap2, GATK, DeepVariant) CNV modeling, STR detection tools and methylation callers Homologous region analysis and control gene normalization PGx variant interpretation and allele resolution Experience with long-read technologies (ONT, PacBio) and signal-level data Strong analytical, problem-solving, and communication skills Preferred Qualifications Experience with machine learning models for variant classification Knowledge of clinical genomics and regulatory standards Familiarity with pharmacogenomic databases (e.g., PharmGKB, CPIC) PHYSICAL DEMANDS AND WORK ENVIRONMENT: Frequently required to sit Frequently required to stand Frequently required to utilize hand and finger dexterity Frequently required to talk or hear Frequently required to utilize visual acuity to operate equipment, read technical information, and/or use a keyboard Occasionally exposed to bloodborne and airborne pathogens or infectious materials EEO Statement: Baylor Genetics is proud to be an equal opportunity employer dedicated to building an inclusive and diverse workforce. We do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, gender identity, veteran status, disability, genetic information, pregnancy, childbirth, or related medical conditions, or any other status protected under applicable federal, state, or local law.

Baylor Genetics, one of the world leaders in clinical molecular genetics, is excited to announce an opening in the Clinical Genomics Interpretation (CGI) division. This role requires a comprehensive understanding of clinical genetics, familiarity with reviewing clinical notes, and ability to interpret a pedigree. As part of the WGS Clinical Indication Team, the “Clinical Genomic Scientist” reviews clinical notes and converts patient phenotypes into Human Phenotype Ontology (HPO) terminology, records prior genetic testing history, interprets family history from pedigrees, and confirms consent answers from test requisition forms. The Clinical Genomic Scientist position is a remote work opportunity, with daily huddles, clear objectives, and flexible scheduling. Come join our team from the comfort of your home office! Duties and Responsibilities on the WGS Clinical Indication Team: 80 to 100%: Reviewing test requisition forms and clinical notes, extracting clinical information into structured data, such as HPO terms Up to 20%: As needed, opportunities for cross-training in WGS variant curations or WGS report writing may become available Qualifications Degree: Master's in Genetic Counseling, MD/PhD with a background in clinical genetics Preferred: Master's in Genetic Counseling Experience: Expertise in concepts of clinical medicine, genetics, genomics, and molecular biology. Experience in communicating genetic details effectively. Excellence in reading/writing medical language. Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook). Desired: Experience in genetic counseling, familiarity reviewing clinical notes and medical writing. Desired: Familiarity with American College of Medical Genetics (ACMG) variant curation guidelines. Desired: Knowledge of genomic variation and its correlation with human disease. Rank: Clinical Genomic Scientist - Clinical Indication I Degree: Masters in Genetic Counseling, MD, or PhD in clinical medicine, genetics, molecular biology, or equivalent. 0-1 years of experience with Human Phenotype Ontology (HPO)-related work and/or clinical experience. Rank: Clinical Genomic Scientist - Clinical Indication II Degree: Masters in Genetic Counseling, MD, or PhD in clinical medicine, genetics, molecular biology, or equivalent. 2-4 years of experience with Human Phenotype Ontology (HPO)-related work and/or clinical experience. Rank: Clinical Genomic Scientist - Clinical Indication III Degree: Masters in Genetic Counseling, MD, or PhD in clinical medicine, genetics, molecular biology, or equivalent. 4-6 years of experience with Human Phenotype Ontology (HPO)-related work and/or clinical experience. Thorough understanding of American College of Medical Genetics (ACMG) variant curation guidelines. Track record of high quality and leading projects toward goals Rank: Clinical Genomic Scientist - Clinical Indication - Senior Degree: Masters in Genetic Counseling, MD, or PhD in clinical medicine, genetics, molecular biology, or equivalent. 4-6 years of experience with Human Phenotype Ontology (HPO)-related work and/or clinical experience. Thorough understanding of American College of Medical Genetics (ACMG) variant curation guidelines. Track record of high quality, leading projects toward goals, training coworkers, demonstration of workflow process improvement Competencies: Quality Assurance, Analytical and Problem-Solving Skills, Technical Skills, Interpersonal Skills, Oral and Written Communication, Teamwork, Organizational Support, Safety and Security, Dependability, Innovation, Adaptability. Physical Demands and Work Environment: At your Home Office: Frequently required to sit, using screen, keyboard, and mouse. Punctuality attending virtual meetings Occasional weekend rotation may be needed (for example, once a month)

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: The Director of Clinical Science will lead the pre-commercial and key aspects of post-commercial Global Clinical Science team at Dexcom. As a Director of Clinical Science, you will leverage your scientific, medical device, and therapeutic expertise along with executive management skills to drive the global pre-commercial clinical strategy. Your team will lead the development, design, analysis and reporting of Dexcom's clinical studies to meet the labeling, claims, and global regulatory needs of the business. Your team will be responsible for interactions with regulatory agencies as needed and will use your scientific, engineering and medical knowledge to provide directives to teams and study sites as needed. Where you come in: Provide leadership and long-term vision to the Global Clinical Science team to meet the business objectives. Provide input on best practices in clinical research to develop CGM products in a regulated environment inclusive of gold standard endpoints and outcome measures, scientific/ clinical evaluations, study instruments, questionnaires, and relevant standards for evaluating medical devices Informs clinical evaluation (plans and reports), clinical trial protocols, protocol amendments, and scientific publications. Facilitates communication between Commercial, Marketing, R&D, Clinical Program Management, Regulatory & Scientific Affairs, Medical Writing, Product Development, Quality Assurance/Compliance, Medical Affairs, and external CROs. Conduct team meetings and present regular updates to senior staff. Participates in clinical study or clinical evaluation timelines, and budgets Examine data sets and determine the best end-to-end analysis plan to address key scientific questions Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature and staying abreast of current clinical practice. What makes you successful: You will have a PhD, MD, and/or equivalent in endocrinology, metabolic disease or related field with extensive clinical research experience in medical devices. Excellent communication and interpersonal skills. Ability to simplify complex concepts and communicate these to non-clinical team members Expertise in medical writing, including authoring and leading clinical evidence reports, clinical study reports, and other reports needed for regulatory filings and meetings, in the US and globally Optional but nice to have: Advanced Programming Skills (Python, R, SPSS, SAS, MatLab, Etc) and demonstrated advanced statistical analysis experience Experience in the European market Ability to work in a matrixed organization What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: 15+ years of industry experience Typically requires a Bachelor's degree with 9+ years of successful management experience in relevant industry Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $199,600.00 - $332,600.00

Twist Bioscience is seeking a Field Application Scientist, a consultative field applications scientist with strong experience in the biologics field. In this position, you will play a key role on the Sales team, acting as the main scientific contact for major pharmaceutical, biotech, and related companies. Your primary responsibility will be to help boost Twist's market presence with key accounts in areas such as antibody production, variant libraries, oligo pools, gene synthesis and biopharmaceutical antibody discovery and optimization. You will provide pre- and post- sale technical support, develop strategic goals, build and maintain important customer relationships, identify business opportunities, and stay updated on market trends to drive new opportunities. Your efforts will help increase Twist's value to key customers and maximize revenue for Twist Bioscience. You'll work closely with the sales team to create strategies aimed at growing existing business and identifying new high-value customers (for example KOLs). What You'll Be Doing: Training on Twist technology, products and services to enable you to translate Twist capabilities Providing expert understanding and strong technical competency when discussing and articulating Twist's capabilities, product and service offerings with selected pharmaceutical, biotechnology, and other related companies. Building and nurturing relationships with stakeholders and customers to better understand their strategic direction and perspectives. Prospecting and generating lists of potential customers, collaborators, and partners that will create revenues from antibody production, variant libraries, oligo pool, gene synthesis sales as well as sales of products that are in alpha testing phase. Providing application support for pre- and post- sales activities for Twist's product portfolio including genes, antibodies, custom DNA libraries, and oligo pools to help support the sales team to achieve quota. Travelling locally and regionally (50% time) to work in the field with Sales account managers, attending meetings with key customers and participating in trade shows. Presenting and pitching Twist capabilities and example case studies at conferences, seminars, trade shows and internal/external meetings Identifying, nurturing, and managing collaborations to network and collaborate on leads with the account management sales team. Supporting the sales team in technical discussions, presentations, and meetings with selected pharmaceutical, biotechnology, and other related companies. Generating and driving a continuous, seamless deal flow when combining SynBio products with Biopharma services into a deal, enabling high-value contracts and clear commercial agreements to be established that fully cover both the services provided by the Twist Biopharma division and the products provided by the Twist Synthetic Biology division. Developing strong working relationships with subject matter experts throughout Twist, assigning and coordinate tasks to more qualified co-workers involved in the pursuit of each opportunity. Networking with customers and providing feedback to Marketing on customer requirements for new applications or products. Following regulatory and ISO 13485 requirements What You'll Bring to the Team Advanced degree and a minimum of 5 years of experience and success in synthetic biology and development within bio-pharmaceutical /biotech/protein engineering segments. Experience developing and cultivating customers and opportunities in the therapeutic, tool or diagnostic industry organization Strong technical knowledge of protein engineering and gene synthesis In-depth knowledge and experience within the variant library and antibody engineering space Experience working in a corporate, global or regional sales and marketing role involving gene mutant library generation and/or antibody discovery and development products/services is preferred High attention to detail High self-motivation and must have demonstrated ability to work in a collaborative team environment Excellent verbal and written communication skills Experience of customer support and use of CRM system is a bonus About Twist Bioscience Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA. At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers. Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary Reporting to the Director of Clinical Development, the Clinical Scientist/Senior Clinical Scientist will provide scientific input to early and later stage clinical development programs. Responsibilities * Contribute to the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigator brochures, CRFs, ICFs, CSRs) * Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations * Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study * Assist in communicating a clear overview of trial results * Collaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables * Collaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissions * Review and synthesize scientific literature and competitive intelligence to support study and program strategy * Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials * Support preparation of scientific material for conference presentations or publications * Contribute to the authoring and revision of regulatory submissions * Perform analyses and generate scientific slide decks based on clinical, translational and other datasets Minimum Qualifications * Advanced scientific or clinical degree (eg PhD, PharmD, MPH, etc). * Clinical Scientist: 1-3 years/ Senior Clinical Scientist: 4-8+ years of previous experience in clinical or related research * Excellent oral and written communication skills and analytical skills * Ability to work collaboratively in a fast-paced, team-based matrix environment * Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators Preferred Qualifications * Experience in cellular therapies/CAR-T trials * Experience in Phase 1/Phase 2 clinical trials Competencies * Collaborative - Openness, one team, positivity * Undaunted - Fearless, can-do attitude, self-starter * Results Orientation - Delivering progress toward our mission; Sense of urgency in solving problems; Attention to details; Practical * Entrepreneurial Spirit - Proactive; Ownership mindset; Thinks outside the box CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Clinical Scientist: Base pay range of $125,000 to $140,000+ bonus, equity and benefits Senior Clinical Scientist: Base pay range of $150,000 to $170,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary Reporting to the Director of Clinical Development, the Clinical Scientist/Senior Clinical Scientist will provide scientific input to early and later stage clinical development programs. Responsibilities Contribute to the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigator brochures, CRFs, ICFs, CSRs) Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study Assist in communicating a clear overview of trial results Collaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables Collaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissions Review and synthesize scientific literature and competitive intelligence to support study and program strategy Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials Support preparation of scientific material for conference presentations or publications Contribute to the authoring and revision of regulatory submissions Perform analyses and generate scientific slide decks based on clinical, translational and other datasets Minimum Qualifications Advanced scientific or clinical degree (eg PhD, PharmD, MPH, etc). Clinical Scientist: 1-3 years/ Senior Clinical Scientist: 4-8+ years of previous experience in clinical or related research Excellent oral and written communication skills and analytical skills Ability to work collaboratively in a fast-paced, team-based matrix environment Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators Preferred Qualifications Experience in cellular therapies/CAR-T trials Experience in Phase 1/Phase 2 clinical trials Competencies Collaborative - Openness, one team, positivity Undaunted - Fearless, can-do attitude, self-starter Results Orientation - Delivering progress toward our mission; Sense of urgency in solving problems; Attention to details; Practical Entrepreneurial Spirit - Proactive; Ownership mindset; Thinks outside the box CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Clinical Scientist: Base pay range of $125,000 to $140,000+ bonus, equity and benefits Senior Clinical Scientist: Base pay range of $150,000 to $170,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

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 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.

**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** The Lowance Center for Human Immunology is seeking a highly motivated and experienced Lab Manager and Researcher to support and lead the day-to-day operations in an academic research lab focused on immunology and rheumatology. This position will oversee laboratory personnel, manage research operations, and conduct grant-supported scientific research. The Associate Academic Research Scientist performs a wide range of highly technical and complex research duties and has documented scientific achievements and increasing technical, management, leadership, and professional expertise necessary to advance basic and/or translational research programs. KEY RESPONSIBILITIES: + Demonstrated knowledge of research and experimental platforms for analyzing, design and interpreting results Investigates and recommends potential alternative approaches to improve the quality of results of basic and/or translational research. + Demonstrates increased responsibility through management of teams and leadership of scientific projects by applying advanced knowledge, skills, and input necessary for protocol development, as well as facilitating in some training aspects of other team members. + Aids in writing IACUC, IRB, Biosafety and other approval documents. + Oversees quality assurance of research conducted by other team members. + May assist in grant and other funding applications as necessary and appropriate, or with approval of the responsible faculty director, may have their own research projects and/or have full responsibilities for specific areas of instrumentation or methodology development and user support. + With the approval of the responsible faculty director, may be principal investigators on funded proposals. + Performs other responsibilities as required. MINIMUM QUALIFICATIONS: + PhD and one year of professional level experience in a technical or research lab. + Or master's degree and three years of professional level experience in a technical or research lab. + Or bachelor's degree and five years of professional level experience in a technical or research lab. + Laboratory experience should be based on area of assignment. + Internship experience or experience prior to attaining the qualifying degree is not considered eligible work experience for this job classification. NOTE: Position tasksaregenerallyrequired tobe performed in-person at an Emory University location. Remote workfrom homedayoptions may be grantedatdepartmentdiscretion.Emory reserves the right to changeremote workstatus with notice to employee **Additional Details** Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: ************ (V) | ************ (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call ************ (Voice) | ************ (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination. **Connect With Us!** Connect with us for general consideration! **Job Number** _147730_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Medicine: Immunology_ **Job Category** _Laboratory Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory Campus-Clifton Corridor_ **Remote Work Classification** _Primarily On Campus_ **Health and Safety Information** _Working in a laboratory_

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.

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive. Position Summary Under direction of the Manager of Immunohematology Reference Laboratory, performs advanced immunohematology testing on clinical and research specimens for the resolution of serologic problems and provides the correct blood product for transfusion based on these results. Performs and interprets molecular testing on clinical and research specimens if applicable to the laboratory. Perform blood product component preparation if applicable to the laboratory. Provides the most appropriate blood in a timely and accurate manner and provides phone consultation to customers. Total Rewards Package Benefits Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others. Responsibilities Handles and processes specimens, ensuring proper identification. Performs serologic and molecular tests according to SOP on clinical, study, QC and research samples. Recognizes and resolves procedural discrepancies in testing results. Interprets laboratory results. Reports laboratory results. Maintains accurate and complete records. Perform reagent preparation Operates laboratory equipment correctly and perform quality control testing on equipment and reagents. Knows acceptable levels of performance. Maintains controlled inventories of reagents and laboratory materials. Performs secondary review and release of test results and provides feedback to ensure accurate reporting of results. Adheres to all required FDA, AABB (American Association of Blood Banks),CLIA (Clinical Laboratory Improvement Act), OSHA (Occupational Safety and Health Administration), and CAP (College of American Pathology) regulations. Follows cGMP (current Good Manufacturing Practices) standards. Support implementation and validation of new tests/equipment. Assists in the training of new personnel and training of students. Assess competence of clinical diagnostic lab staff if applicable Provides on call and/or overtime coverage as required. Listens, anticipates and responds to the needs of internal and external customers and strives to meet expectations. Communicates clearly, accurately and respectfully with customers, donors, and colleagues, ensuring that necessary information is shared. Notifies management or other appropriate persons of problems or issues as appropriate. Works effectively with inter or intra-department(s) and project teams to meet customer needs and organizational goals. Participates in quality and process improvement. Supports and promotes Versiti mission and values, both at work and in the community. Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification Complies with all policies and standards Qualifications Education Bachelor's Degree from an accredited college or university in Clinical Laboratory Science required Medical Technology (MLS/CLS/MT) required or science related degree with certification as a BB technologist required Experience 1-3 years experience working in an Immunohematology reference laboratory or transfusion service preferred Knowledge, Skills and Abilities Working knowledge of immunohematology and immunology theory. Skill in the operation of laboratory equipment, instrument, computer and materials. Effective time managing and organizational skills to perform multiple laboratory tests simultaneously. Maintain accurate, timely records of patient information and laboratory results. Strong detail orientation and analytical ability to evaluate and ensure accuracy of data related to laboratory results and patient information. Effective verbal and written communication skills, including the ability to convey understanding of factual and theoretical information and make recommendations to customers. Effective problem-solving skills. Ability to work independently and as a team member. Licenses and Certifications MLS/CLS/MT/BB American Society for Clinical Pathologist (ASCP) certification required or equivalent required Or; two-year degree from an accredited college, university or technical college in a Medical Laboratory Technician program with an MLT certification and 4-6 years of IRL experience required Tools and Technology Personal Computer (desktop, laptop, tablet) required General office equipment (computer, printer, fax, copy machine) required Microsoft Suite (Word, Excel, PowerPoint) required General laboratory equipment including centrifuges, automated cell washers and incubator/waterbaths for performing clinical tests. required Molecular instrumentation such as light cyclers required Pipettes (single channel, multi-channel, electronic, etc.) required pH meter, microscopes required Not ready to apply? Connect with us for general consideration.