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  • Pharmaceutical Development Scientist

    STAQ Pharma 3.7company rating

    Drug safety scientist job in Columbus, OH

    The Pharmaceutical Development Scientist is a hands-on technical role responsible for the formulation, development, optimization, and technology transfer of sterile and non-sterile drug products across STAQ Pharma's 503B Outsourcing Facilities. Reporting directly to the Chief Pharmaceutical Officer, this position supports product development initiatives from concept through scale-up and commercialization, driving innovation, process improvement, and lifecycle management of compounded drug products. The scientist collaborates closely with Manufacturing Sciences & Technology (MS&T), Quality, and Production teams to translate laboratory-scale formulations into scalable, validated CGMP manufacturing processes. Responsibilities include conducting pre-formulation and compatibility studies, preparing R&D and pilot-scale batches, and analyzing analytical and stability data to identify optimal formulations that maximize quality, performance, and product expiration dating. This role requires strong analytical chemistry expertise-including the ability to interpret UPLC chromatograms, assess impurity profiles, and apply ICH and FDA 503B guidance-to guide formulation strategy, product development, and technology transfer activities. Key Responsibilities: Develop, optimize, and scale formulations for sterile and non-sterile dosage forms in compliance with CGMP, FDA 503B, and ICH guidelines. Conduct pre-formulation studies, excipient compatibility testing, and stability evaluations to inform formulation design and shelf-life optimization. Design and execute experiments to assess formulation feasibility, process robustness, and long-term product stability. Prepare and manufacture laboratory-scale, R&D, and pilot-scale batches for testing and process development. Lead and support technology transfer activities for new and existing products, ensuring seamless transition from R&D to manufacturing and between STAQ Pharma sites. Conduct literature reviews and data analysis to identify innovative formulation approaches and support development strategy. Analyze data from HPLC, GC, dissolution, and stability studies to assess potency, purity, and impurity profiles. Collaborate with MS&T, Quality, and Production teams to ensure manufacturing processes are robust, validated, and scalable. Develop and execute stability protocols, trend data, and prepare detailed technical summaries and reports. Write and maintain technical documentation, including batch records, development protocols, SOPs, and technical reports in accordance with CGMP standards. Support investigations of out-of-specification (OOS) or out-of-trend (OOT) results and contribute to CAPA development and implementation. Participate in audits, inspections, and internal quality reviews to ensure regulatory and operational compliance. Qualifications: Bachelor's, Master's, or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline. Minimum of 3-5 years of hands-on experience in CGMP pharmaceutical formulation or product development (503B, CDMO, or sterile pharma manufacturing preferred). Demonstrated experience in formulation design, stability testing, and technology transfer. Proficiency in analytical chemistry techniques, including UPLC, GC, and dissolution testing; ability to interpret chromatograms and impurity profiles. Strong working knowledge of ICH Q8-Q10, FDA 503B guidance, and applicable USP chapters. Experience in scale-up and process optimization for aseptic and non-sterile drug products. Excellent technical writing, communication, and organizational skills. Ability to work independently, prioritize multiple projects, and collaborate effectively across cross-functional teams and sites.
    $63k-85k yearly est. 4d ago
  • Clinical Variant Scientist

    MacHaon Diagnostics

    Remote drug safety scientist job

    Title: Clinical Variant Scientist (Part-Time, Remote) Company: Machaon Diagnostics Employment Type: Part-Time (10 hrs/week) About Us Machaon Diagnostics is a specialized clinical reference laboratory and CRO focused on hematology, immunology and rare disease diagnostics. We support physicians, hospitals, and pharma/biotech partners by delivering fast, high-quality molecular and functional testing. Our genetics program includes next-generation sequencing assays, somatic and germline variant interpretation, and the development of innovative assays in complement biology, immune dysregulation, and related pathways. About the Role Machaon Diagnostics is seeking a part-time, remote Clinical Variant Scientist to support our growing genetics program focused on rare disease, immunology, hematology, and complement biology. You'll play a key role in variant interpretation, report drafting, and assay-development support. This role offers flexible hours, remote work, and meaningful impact in clinical diagnostics. What You'll Do Interpret germline and/or somatic variants using ACMG/AMP guidelines Review NGS data, QC metrics, and annotation outputs Curate variants using ClinVar, gnom AD, HGMD, and related databases Draft clear, concise clinical reports Maintain and update internal variant knowledge bases Support new assay development and validation Ensure compliance with CLIA/CAP standards and SOPs What We're Looking For Required: MSc or PhD in Genetics, Genomics, Molecular Biology, or related field 1-3+ years experience in clinical variant interpretation Preferred: Experience with rare disease, immune dysregulation, or complement biology Prior work in a CLIA/CAP-accredited lab What We Offer Part-time remote role (approx. 10 hrs/week) Flexible schedule Opportunity to contribute to innovative rare-disease diagnostics Supportive and collaborative team environment How to Apply Submit your CV and a brief note about your variant-interpretation experience to: james.kain at machaondiagnostics.com Subject: Clinical Variant Scientist - Part-Time
    $125k-168k yearly est. 4d ago
  • Safety Scientist

    Mindlance 4.6company rating

    Remote drug safety scientist job

    Work from Home answer: There is no routine work from home, but we do allow contractors on an occasional basis at the discretion of the manager and dependent on things such as work volume, employee being in good standing, etc. Requests to work from home must be made in advance, and may be denied at the discretion of the manager. In instances of inclement weather, we would allow our contractor and permanent employees to work (safely) at home Contract duration 6 months with option to extend. Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required Maintain a listing of all administrative changes and updates Ensure all processes as described are operational Alert Project Management when activities fall outside SOW Process and evaluate AE reports according to the customer's standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings Assist in the reconciliation of clinical and safety databases Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment reports Perform literature review for identification of case reports and other relevant safety information Liaise with both internal and external vendors (clients, patients and HCPs) Review/Quality check (QC) of source documents, coding, data entry, report generation and distribution Monitor compliance metrics and ensure appropriate documentation when deficient Assist in evaluation and validation of systems to support safety Other duties as assigned by management Qualifications Registered Nurse, Pharmacist, or other degree in a science or health-related field Good knowledge of global and local PV regulations and legislation, both pre-and post-marketing required. Minimum of 1 year of experience in a pharmaceutical company or a service provider (e.g., CRO) with case processing responsibilities Pharmacovigilance (PV) reporting experience should include drugs and biologics. Experience with safety surveillance of vaccines and medical devices a plus but not required Proficient with case processing including use of coding dictionaries, case narratives preferably within ARISg and/or Argus. Proficient with computer programs (MS Word, PowerPoint, Excel) Good communication, interpersonal interaction, and organizational skills are essential Ability to manage multiple client projects simultaneously with good time management skills. Fluent in English, additional language fluency a plus, but not required Additional Information Thanks & Regards, Mahesh Kumar | Team Recruitment | Mindlance, Inc. | W : ************ ****************************
    $76k-110k yearly est. Easy Apply 1d ago
  • Lead Clinical Scientist, Transplant

    This Role This

    Remote drug safety scientist job

    Biogen's West Coast Hub is seeking an accomplished and highly motivated Lead Clinical Scientist to provide scientific, strategic, and operational leadership for our organ transplantation clinical development program. This role will help lead the design, execution, and advancement of late-stage clinical trials in antibody-mediated rejection and other conditions in organ transplantation.The Lead Clinical Scientist will play a critical role in ensuring the highest standards of patient safety, data quality, and scientific integrity throughout the clinical development process. This position requires subject matter expertise in solid organ transplantation, the ability to oversee complex global trials, and strong cross-functional and external collaboration skills. The responsibilities of this role may vary depending on the specific indication and trial requirements.Who You AreYou have significant experience in clinical trials for organ transplantation and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients.What You Will DoClinical Development LeadershipHelp lead the design, execution, and analysis of late-stage organ transplantation clinical studies, ensuring alignment with program strategy while adhering to GCP and regulatory requirements Develop and refine clinical development plans, study protocols, and other trial related documents. Medical Oversight Provide medical and scientific oversight of clinical trials Implement study-specific medical monitoring plans and support medical monitoring activities across clinical trials including ongoing review of patient eligibility, safety data, and protocol adherence Monitor patient safety by reviewing adverse events, laboratory results, and emerging data. Provide real-time medical guidance to investigators during trial conduct, including assessment of complex or unexpected clinical scenarios Participate in and contribute to Data Monitoring Committees, adjudication committees, and safety review meetings as required Data Quality & Integrity, Enrollment and Retention Support case report form design and modification to ensure optimal data capture, scientific rigor, and operational feasibility Direct ongoing review of clinical trial data, including query resolution, to ensure completeness, accuracy, and consistency. Partner with Data Management and Biostatistics to develop high-quality data review plans. Ensure that study databases are clean, audit-ready, and meet standards for regulatory filings. Work with clinical operation and site investigators to proactively identify and address enrollment challenges, ensuring recruitment goals are met Develop, maintain and strengthen investigator and investigator site relationships at specific study sites. Implement strategies to support patient enrollment and retention, including improving site engagement, participant experience, and adherence to study procedures Cross-Functional & External Collaboration Provide leadership to cross-functional project teams, partnering with clinical operations, biometrics, regulatory affairs, biomarkers, clinical pharmacology, and medical writing to deliver on study objectives. Establish and maintain strong external collaborations with investigators, academic partners, CROs, and other clinical trial stakeholders to ensure successful study execution. Working collaboratively within clinical development team performing assignments/tasks as requested Represent Biogen at global scientific conferences, investigator meetings, and advisory boards. Support preparation and presentation of clinical data to health authorities, including FDA and EMA. Strategic Impact Anticipate scientific and operational challenges, proposing innovative solutions to advance program timelines and deliverables. Contribute to overall portfolio strategy by integrating emerging scientific insights and competitive intelligence. Requirements Advanced scientific degree required (MD, PhD, PharmD, or equivalent) 6+ years of clinical development experience in the biotechnology or pharmaceutical industry or equivalent, preferably in organ transplantation Ability to survey and interpret scientific literature related to assigned projects Strong interpersonal skills and ability to collaborate across internal teams and with external clinical partners. Strong analytical skills coupled with excellent oral and written communication skills to present findings and relevant data with the ability to educate and influence senior stakeholders and external experts. Strong organizational skills and ability to thrive in a fast-paced environment while prioritizing and responding to changing business needs Willingness to travel domestically and internationally (approximately 30%) #LI-RD8 Job Level: Management Additional Information The base compensation range for this role is: $191,000.00-$278,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
    $191k-278k yearly Auto-Apply 37d ago
  • Associate Director/Director, Clinical Scientist

    Eyepoint Pharmaceuticals 4.5company rating

    Remote drug safety scientist job

    Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for: preventing blindness through vision-saving medications delivering best-in-class proprietary pharmaceutical technologies transforming ocular drug delivery We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position is reporting to the VP, Clinical Development and is remote. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio. Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs. Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans. Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials. Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required. Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program. Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation. Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations. Assist with study milestones and study metrics in collaboration with clinical operations. Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines. Qualifications Primary skills and knowledge required include, but are not limited to the following: A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required. Experience in ophthalmology and familiarity with drug/device combination products Experience with all phases of clinical drug development including regulatory submissions Ability to survey and interpret scientific literature related to the assigned portfolio of products Strong communication, organizational and interpersonal skills are required. Successful work experience in a matrix team environment with cross functional teams is required. Independent decision-making and analytical skills are required. Level of Education Required: Advanced degree in life science/clinical/medical field, PhD or PharmD Number of Years of Experience in the Function and in the Industry: Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level Minimum of 10 years of clinical development/research and R&D experience preferred at Director Level Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Remote Min USD $154,500.00/Yr. Max USD $249,947.00/Yr.
    $154.5k-249.9k yearly Auto-Apply 57d ago
  • Clinical Scientist

    Crinetics Pharmaceuticals 3.9company rating

    Remote drug safety scientist job

    Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Clinical Scientist will be working within a multi-disciplinary team focusing on a Clinical Development Program. This individual will provide clinical expertise and scientific insights to help elaborate a protocol for phase 1 - 3 studies then monitor, track, and analyze subjects' data in these studies. The incumbent will collaborate with all the groups involved in Clinical Development e.g., Clinical Pharmacology (CP), Clinical Operations, Medical Writing, Biometrics, Pharmacovigilance, Regulatory Affairs, HEOR and Medical Affairs. Essential Job Functions and Responsibilities: These may include but are not limited to: Conduct data analyses before and during clinical studies to support medical decision making, create presentation slides, and prepare for development division discussion meetings. Perform high quality clinical data review to identify events of special interest from data within the EDC system for further investigations. Collaborate with biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) to discussion with clinical team. Perform regular trend analysis in ongoing clinical trials. Lead periodic Medical Review meetings. Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings. Contribute to the development of relevant sections of regulatory documents such as protocols, amendments to protocols, informed consent forms, briefing books, safety updates, responses to Health Authorities questions. Contribute to the development of study documents such as feasibility questionnaires, study plans, electronic Case Report Forms (eCRFs), eCRF guidelines and other essential trial specific documents. Collaborate in cross-functional meetings (with internal stakeholders and/or external consultants) to develop clinical development plans. Support Clinical Operations, CROs, and site staff on study protocol related questions Support preparation for safety review committees, DSMBs/DMC incl. data review and development of presentations Collaborate with Medical Affairs and Patient Advocacy to support effective working relationships with key investigators, key opinion leaders and patient advocates. Participate in research site identification and relationship building with CROs in this space. Track progress, take notes and plan meetings for the protocol discussion group (Biometrics and Clinical Research, plus ad hoc functions). Other duties as assigned. Education and Experience: Required: MD, Ph.D., Pharm. D., MPH (Master of Public Health), MSN or RN with 8 years of industry related experience with a minimum of 2 years clinical research experience in clinical development within a biopharmaceutical company. Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters, etc.). Great analytical skills and a passion for “search and find” among complex data generated in clinical studies. Collaborative, effective writing skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization. Ability to thrive and flourish in a fast-paced, dynamic, entrepreneurial small company environment; ability to prioritize and parallel process multiple workstreams, comfortable “changing gears” and remaining flexible, as well as making definitive decisions. Ability to inspire and earn respect from the leadership team, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team Ethical, with the highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders. Desire to develop personal and communication skills through several complex tasks and challenges. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. The Anticipated Base Salary Range: In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $144,000 - $180,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
    $144k-180k yearly Auto-Apply 29d ago
  • Scientist, Analytical Development

    Moderna Theraputics

    Remote drug safety scientist job

    The Role: Moderna is seeking a Scientist / Manager for our Norwood, MA Technology Center to lead the Reference Standard strategy and lifecycle management that underpins analytical activities for our mRNA programs. Partnering with technical and operations teams across Analytical Development, Analytical Tech Operations, Quality Control, Analytical Science & Technology, Process Development, Manufacturing, and Regulatory Affairs, this position will design and execute the acquisition, qualification, re-qualification, change-control, and phase-transition plans that keep RNA, lipid nanoparticle, and drug-product reference standards fit-for-purpose throughout clinical development. Reporting to the Director of Analytical Science, this person will oversee aliquoting, inventory, distribution, and shipments with end-to-end traceability; mine and trend analytical data to inform decisions; author protocols and regulatory submissions; and champion a culture of safety, data integrity, and cross-functional collaboration. Here's What You'll Do: * Lead the end-to-end Analytical Reference Standard strategy for RNA, lipid nanoparticle and drug product for mRNA programs in clinical development. * Work closely with colleagues within Analytical Development, Process Development, Analytical Tech Operations, Analytical Sciences and Technology and Quality Control teams to manage Reference Standard lifecycle activities (acquisition, qualification, requalification/stability, phase transition change/bridging), and drive timelines using project management tools. * Review, track and assess Reference Standard data, and document and communicate findings. * Oversee all logistic for Reference Standard, such as aliquoting, storage, inventory, distribution, shipping, and disposal activities to ensure full compliance ad traceability. * Demonstrate independent scientific judgment to study design, data interpretation, technical protocols and reports, regulatory filings, and responses to agency queries; Clearly present findings to multidisciplinary teams. * Maintain a safe laboratory work environment and be accountable for good documentation practices. Here's What You'll Bring to the Table: * B.S. with 5-10 years or MS with 3-5 years of relevant industry experience in analytical development, or quality control, or closely related field. GMP analytical-chemistry experience is preferred. * Proven ability to manage projects of significant scope and complexity, while meeting all deliverables and timelines. * Hand-on experience in data analysis and statistical evaluation. * Hand-on experience in analytical method development and analytical reference standard. * Experience in documentation and authoring regulatory submission documents in pharmaceutical or biotech industries * Exceptional organizational, communication, and critical thinking skills, and the ability to thrive in an interdependent and idea-rich environment. * Excellent interpersonal and collaborative skills. * Ability to navigate through ambiguity and rapid growth and adapt to change. * Previous hands-on industry experience with analytical development for nanoparticles, RNA, therapeutics, or biologics is a plus and preferred * This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. * Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs * A holistic approach to well-being, with access to fitness, mindfulness, and mental health support * Family planning benefits, including fertility, adoption, and surrogacy support * Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown * Savings and investment opportunities to help you plan for the future * Location-specific perks and extras The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 *
    $109.2k-174.6k yearly Auto-Apply 60d+ ago
  • Clinical Scientist - Interventional

    Gehc

    Remote drug safety scientist job

    SummaryAs the Clinical Scientist - Interventional, you will be responsible for working daily in close partnership with Interventional key clinical partners as well as global and local GE HealthCare colleagues. You will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionEssential Responsibilities: Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership Support adoption of new technology or clinical applications through advocacy and evidence Participate in customer presentations regarding use of Interventional products for institution research purposes Closely connected with GEHC global modality clinical and research and development teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns Grow technology leadership mindshare through joint scientific presentations and publications Lead and represent the global modality technical, scientific and product expertise in the US and Canada to support local clinical teams and best-in-class customer experience on new products Study new technology concepts and leverage expertise to move initiatives forward Qualifications/Requirements: PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field Preferred 1+ year(s) of experience in Interventional healthcare industry or clinical research Knowledge of Interventional procedures, anatomies, clinical practice Knowledge of Interventional products including IGS product line and Advantage Windows applications Excellent customer relationship management and collaboration skills Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Desired Characteristics: 5 + years experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: Yes
    $97.6k-146.4k yearly Auto-Apply 23d ago
  • Senior Principal Scientist, Biologics - Translational Medicine

    Telix Pharmaceuticals

    Remote drug safety scientist job

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix This role provides technical and analytical expertise for translational to early phase biologics process development and manufacturing activities ensuring developability and manufacturability assessments and drug substance intermediates are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance. This role is responsible for managing projects in multiple technology areas (e.g. cell banking, bioprocess/bioconjugation, analytical, formulation, and/or other) at external partners, as well as contributing to internal cross-functional collaborations to develop and support future preclinical activities, process development, and/or clinical manufacturing. The Senior Principal Scientist, Biologics - Translational Medicine is a subject matter expert who acts as the Biologics lead for one or more therapeutic programs and should be comfortable communicating with cross-functional teams including governance forums with senior leadership team members in formal settings and third-party meetings, be an expert in one or more technical areas (e.g. cell banking, bioprocess/bioconjugation, analytical, formulation, and/or other), and manage their own workload to complete assignments autonomously with occasional feedback from senior-level colleagues and/or their manager for more complicated topics. Key Accountabilities: Oversee development projects for multiple technology areas (e.g. cell banking, bioprocess/bioconjugation, analytical, formulation, and/or other) ensuring the appropriate developability and manufacturability assessments to enable future process knowledge, technology transfer, analytical method transfer, design space definition, to produce preclinical and/or clinical drug substance intermediates. Oversee external manufacturing projects to deliver SOPs, batch records, protocols, and reports for multiple technology areas (e.g. cell banking, bioprocess/bioconjugation, analytical, formulation, and/or other) to produce preclinical and/or clinical drug substance intermediates which may include monoclonal antibody or other molecule type bulk, bioconjugate bulk, and vial components of such. Authors and/or reviews source documents and CMC content related to several technology areas (e.g. cell banking, bioprocess/bioconjugation, analytical, formulation, or other) to support early IB, IMPD, and similar regulatory agency applications, especially in areas requiring more sophisticated acumen such as risk-based approach justifications. Ensures appropriate document curation, storage, and compliance through document creation/review/approval within a Quality system. Leads collaborations with external partners to develop selection criteria, assess capabilities, coordinate activities, plan process technology transfer/analytical method transfer, troubleshoot and analyze operational performance, conduct risk assessments, and manage timely deliverables. Mentors other level Scientists on both technical topics as well as Telix values. Education and Experience: Science or engineering degree with minimum relevant experience as applicable: BS with 14 years of experience, MS with 12 years of experience, PhD with 11 years of experience. Minimum 10 years of experience in translational to early phase GMP, quality management system, and CMC compliance and regulation. Demonstrated understanding and application of project management principles and tools. Ability to work in cross-functional, virtual teams. Travel expectation: 10 - 25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments. Key Capabilities: Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE
    $98k-143k yearly est. Auto-Apply 20h ago
  • Staff Machine Learning Scientist, Risk

    Creditly Corp

    Remote drug safety scientist job

    Company Credit Genie is a mobile-first financial wellness platform designed to help individuals take control of their financial future. We leverage artificial intelligence to provide personalized insights and are building a financial ecosystem by offering tools and services that provide instant access to cash, and building credit. Our goal is to empower every customer to achieve long-term financial stability. Founded in 2019 by Ed Harycki, former Swift Capital Founder (acquired by PayPal in 2017). Backed by Khosla Ventures and led by industry pioneers from companies such as; PayPal, Square, and Cash App, we are well positioned to build the future of inclusive finance through cutting-edge technology and customer-centric solutions. Overview Come join our AI/ML and Data Science community at Credit Genie! We are seeking a ML Scientist technical leader with a solid background in Machine Learning and the consumer risk domain, who is excited about solving challenging Machine Learning and Data Science problems and driving results while maintaining the highest bar for methodological rigor. In this role, you will have an opportunity to design and implement our company's next generation of Risk models that will have a vast impact across underwriting, fraud prevention and collections. These models are central to our business and have a direct impact on our customers every day. You will also design, execute, and evaluate new data acquisition processes as well as A/B tests and other experiments. What You'll Do * Set the company's Risk Machine Learning roadmap in collaboration with our cross functional partners * Own the end-to-end design and development of ML solutions that power our products' risk decisioning, driving both optimized risk outcomes and an exceptional customer experience * Work with a growing team of AI/ML experts on the design and implementation of new Risk ML and feature engineering infrastructure * Partner cross-functionally with Product, Analytics, Engineering, and business teams to generate actionable insights and build data-driven models that drive business impact * Set and maintain the highest methodological standards for Data Science across the company * Solve problems that have no clear existing solution and directly impact our customers Requirements * A Bachelor's degree in Computer Science, Statistics, Mathematics, or a related field; an advanced degree is preferred * 8+ years of hands-on experience in machine learning, data science, or advanced analytics * Deep understanding of machine learning algorithms, statistical modeling, and data analysis techniques * Strong problem-solving abilities, attention to detail, and a data-driven mindset * Excellent written and verbal communication skills, with the ability to explain complex technical concepts to non-technical audiences * Proficiency in Python and common ML/data libraries (NumPy, pandas, scikit-learn, XGBoost, etc.) * Experience with SQL and data platforms such as Snowflake, Databricks, and Tableau Benefits and Perks Our goal is to provide a comprehensive offering of benefits and perks that promote better financial, mental, and physical wellness. We believe working alongside each other in person is the best way to build a great product and foster a strong company culture. Our expectation is that employees are in the office five days a week, allowing for optimal collaboration, inclusivity, and productivity. At the same time, we understand that life happens and recognize the importance of flexibility. We are committed to supporting our employees when circumstances arise that require remote work or adjusted schedules. Our goal is to ensure everyone can effectively balance personal and professional responsibilities while maintaining our collaborative and productive environment. Here are some highlights of our benefits and perks offerings, feel free to ask your recruiting partner for more details on our comprehensive offering for employees. * 100% company-paid medical, dental, and vision coverage for you and your dependents on your first day of employment. * Monthly fitness reimbursement up to $100 or a full membership to LifeTime Fitness * 401(k) with a 2.5% match and immediate vesting * Meal program for breakfast, lunch, and dinner * Life and accidental insurance * Flexible PTO Your actual level and base salary will be determined on a case-by-case basis and may vary based on the following considerations: job-related knowledge and skills, education, and experience. Base salary is just one part of your total compensation and rewards package at Credit Genie. You may also be eligible to participate in the bonus and equity programs. You will also have access to comprehensive medical, vision, and dental coverage, a 401(k) retirement plan with company match, short & long term disability insurance, life insurance, and flexible PTO along with many other benefits and perks. Credit Genie is a proud Equal Opportunity Employer where we welcome and celebrate differences. We are committed to providing a workspace that is safe and inclusive, where everyone feels supported, connected, and inspired to do their best work. If you require any accommodations to participate in our recruitment process, please inform us of your needs when we contact you to schedule an interview.
    $92k-154k yearly est. 41d ago
  • Staff Machine Learning Scientist, Risk

    Credit Genie

    Remote drug safety scientist job

    Company Credit Genie is a mobile-first financial wellness platform designed to help individuals take control of their financial future. We leverage artificial intelligence to provide personalized insights and are building a financial ecosystem by offering tools and services that provide instant access to cash, and building credit. Our goal is to empower every customer to achieve long-term financial stability. Founded in 2019 by Ed Harycki, former Swift Capital Founder (acquired by PayPal in 2017). Backed by Khosla Ventures and led by industry pioneers from companies such as; PayPal, Square, and Cash App, we are well positioned to build the future of inclusive finance through cutting-edge technology and customer-centric solutions. Overview Come join our AI/ML and Data Science community at Credit Genie! We are seeking a ML Scientist technical leader with a solid background in Machine Learning and the consumer risk domain, who is excited about solving challenging Machine Learning and Data Science problems and driving results while maintaining the highest bar for methodological rigor. In this role, you will have an opportunity to design and implement our company's next generation of Risk models that will have a vast impact across underwriting, fraud prevention and collections. These models are central to our business and have a direct impact on our customers every day. You will also design, execute, and evaluate new data acquisition processes as well as A/B tests and other experiments. What You'll Do Set the company's Risk Machine Learning roadmap in collaboration with our cross functional partners Own the end-to-end design and development of ML solutions that power our products' risk decisioning, driving both optimized risk outcomes and an exceptional customer experience Work with a growing team of AI/ML experts on the design and implementation of new Risk ML and feature engineering infrastructure Partner cross-functionally with Product, Analytics, Engineering, and business teams to generate actionable insights and build data-driven models that drive business impact Set and maintain the highest methodological standards for Data Science across the company Solve problems that have no clear existing solution and directly impact our customers Requirements A Bachelor's degree in Computer Science, Statistics, Mathematics, or a related field; an advanced degree is preferred 8+ years of hands-on experience in machine learning, data science, or advanced analytics Deep understanding of machine learning algorithms, statistical modeling, and data analysis techniques Strong problem-solving abilities, attention to detail, and a data-driven mindset Excellent written and verbal communication skills, with the ability to explain complex technical concepts to non-technical audiences Proficiency in Python and common ML/data libraries (NumPy, pandas, scikit-learn, XGBoost, etc.) Experience with SQL and data platforms such as Snowflake, Databricks, and Tableau Benefits and Perks Our goal is to provide a comprehensive offering of benefits and perks that promote better financial, mental, and physical wellness. We believe working alongside each other in person is the best way to build a great product and foster a strong company culture. Our expectation is that employees are in the office five days a week, allowing for optimal collaboration, inclusivity, and productivity. At the same time, we understand that life happens and recognize the importance of flexibility. We are committed to supporting our employees when circumstances arise that require remote work or adjusted schedules. Our goal is to ensure everyone can effectively balance personal and professional responsibilities while maintaining our collaborative and productive environment. Here are some highlights of our benefits and perks offerings, feel free to ask your recruiting partner for more details on our comprehensive offering for employees. 100% company-paid medical, dental, and vision coverage for you and your dependents on your first day of employment. Monthly fitness reimbursement up to $100 or a full membership to LifeTime Fitness 401(k) with a 2.5% match and immediate vesting Meal program for breakfast, lunch, and dinner Life and accidental insurance Flexible PTO Your actual level and base salary will be determined on a case-by-case basis and may vary based on the following considerations: job-related knowledge and skills, education, and experience. Base salary is just one part of your total compensation and rewards package at Credit Genie. You may also be eligible to participate in the bonus and equity programs. You will also have access to comprehensive medical, vision, and dental coverage, a 401(k) retirement plan with company match, short & long term disability insurance, life insurance, and flexible PTO along with many other benefits and perks. Credit Genie is a proud Equal Opportunity Employer where we welcome and celebrate differences. We are committed to providing a workspace that is safe and inclusive, where everyone feels supported, connected, and inspired to do their best work. If you require any accommodations to participate in our recruitment process, please inform us of your needs when we contact you to schedule an interview.
    $92k-154k yearly est. Auto-Apply 2d ago
  • Clinical Development Scientist

    Karius 4.2company rating

    Remote drug safety scientist job

    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.
    $69k-97k yearly est. Auto-Apply 45d ago
  • Director Clinical Scientist

    Dexcom 4.7company rating

    Remote drug safety scientist job

    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
    $105k-127k yearly est. Auto-Apply 11d ago
  • Associate Sensory Scientist

    Givaudan Ltd. 4.9company rating

    Remote drug safety scientist job

    Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with our customers, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with. In the USA, we develop, market and produce a wide array of solutions from our 25 most innovative sites, based across the country. Stretch your skills, create and get inspiration from passionate colleagues. Every day, your energy, your thirst for knowledge, and your creativity will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature. As an Associate Sensory Scientist, you will support sensory projects that guide product development and new ideas. You'll apply sensory methodologies and statistical analysis to create insights that help shape taste solutions. You will combine scientific expertise with collaboration across teams to deliver meaningful results and influence decisions with data-driven sensory insights. Reports to: Regional Innovation Manager Your Location: Cincinnati, Ohio You Will: * Provide actionable research for internal technical, marketing, and sales teams and North American customers. You will use data structure and statistical methods to derive insights from sensory data to support decision-making processes. * Work with a team of sensory scientists, technicians, and descriptive panel leader to apply qualitative and quantitative methodologies to create relevant insights and execute sensory testing protocols that align with project goals. * Collaborate with marketing, product management, flavor creation, application, and research teams to ensure sensory perspectives guide our goals. * Contribute sensory expertise to regional and global projects through knowledge sharing. * Maintain accurate records in sensory systems and ensure best practices in data management are followed. * Communicate scientific findings through reports, presentations, and discussions with cross-functional teams internally and externally with customers. Your Professional Profile Includes: * Degree in Data Science, Food Science, Chemistry, Biology, Psychology, or a related discipline. * 2+ years of experience in industry or academia with relevant technical expertise * Sound statistical analysis skills with proven data interpretation knowledge * Relevant software experiences (Compusense, XLSTAT, etc). * Analysis skills in research or product development environments. * Effective written, oral, and presentation skills with the ability to share insights clearly. * Collaborative approach with the ability to work effectively with regional and global partners. * Exhibit a growth mindset and nimble learning * Fluency in English and proficiency in relevant computer and statistical tools. Benefits Medical, dental, and vision coverage and a high-matching 401(k) retirement plan. #LI-Onsite #ZR At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives. You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions. Every essence of you enriches our world. Diversity of perspectives fuels innovation and fosters deeper connections with our employees, customers, and partners. At Givaudan, we are dedicated to cultivating an inclusive environment where every individual's voice is valued and has the power to shape our world. Join us in making a difference together. Remote working: On-site At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives. You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions. Join us and Impact Your World Diversity drives innovation and creates closer connections with our employees, customers and partners. Givaudan embraces diversity and is committed to building an inclusive environment where everyone impacts our world.
    $60k-83k yearly est. 60d+ ago
  • Staff Scientist, Computational Imaging

    Cleerly 3.8company rating

    Remote drug safety scientist job

    We're Cleerly - a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Team You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly's regulated products. Responsibilities Research and develop state-of-the-art AI and non-AI algorithms for coronary CT imaging applications. Translate product and clinical requirements into algorithmic specifications in collaboration with Product and Clinical teams. Partner with Regulatory Affairs to support regulatory submissions (e.g., 510(k), De Novo,PCCP), including generating evidence and documentation. Collaborate with engineering teams to deploy AI and non-AI based solutions in clinical practice. Communicate findings and strategy to internal stakeholders and leadership through clear technical documentation, presentations, and demos. Contribute to intellectual property development through patents and scientific publications. Mentor junior scientists and foster a culture of technical excellence and scientific rigor. Requirements Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field, with 5+ years combined postdoc and/or industry experience; OR an M.S. with 8+ years of relevant experience. R&D experience in medical image processing, demonstrating subject matter expertise in deep learning methods for image quality enhancements, optical flow analysis and CT harmonization. Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis). Strong experience in Python, Tensorflow and pytorch. Prior experience with ITK, OpenCV, VTK. Excellent interpersonal, cross-functional, and cross-cultural collaboration skills. This role will require travel for up to 25% of the time, often for 3 weeks at a time Preferred qualifications 5+ years of industry experience in AI-based medical device development or clinical deployment. Experience supporting FDA regulatory submissions for ML-based software, including familiarity with De Novo, 510(k), and PCCP pathways. Deep domain knowledge in cardiovascular imaging and CT interpretation workflows. TTC*: $265k - $305k *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: H: Humility- be a servant leader E: Excellence- deliver world-changing results A: Accountability- do what you say; expect the same from others R: Remarkable- inspire & innovate with impact T: Teamwork- together we win Don't meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences. Job duties, activities and responsibilities are subject to change by our company. OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (****************************************** All official emails will come *********************** email accounts. #Cleerly
    $68k-102k yearly est. Auto-Apply 1d ago
  • Staff Applied Machine Learning Scientist

    Medium 4.0company rating

    Remote drug safety scientist job

    Medium's mission is to deepen understanding of the world and spread ideas that matter. We are building the best place for reading and writing on the internet-a place where today's smartest writers, thinkers, experts, and storytellers can share big, interesting ideas; a place where ideas are judged on the value they provide to readers, not the fleeting attention they can attract for advertisers. Role Overview One of Medium's core operating principles is “humans first,” but sometimes to do that we need a little help from machine learning-which is why Medium is looking for an experienced Staff Applied ML Scientist to join our team. First and foremost, you'll own Medium's recommendation systems, which serves millions of readers every day by parsing through an ocean of posts and curating perfect literary pearls for each of them. Under the hood, it's a sophisticated and modern ML pipeline, fueled by a two-tower model and separate deep retrieval and ranking stages. Beyond recommendations, you'll also develop ML models to protect our readers from the burgeoning world of AI slop and spam, explore and evangelize new applications for machine learning across Medium's business, and leverage machine learning to ensure that Medium always puts humans first. Key Responsibilities You'll help us apply machine learning thoughtfully across Medium - starting with recommendations, but extending far beyond them. You'll look for places where ML can make the reading and writing experience more personal, relevant, and human. Experiment with ideas like smarter post discovery that helps writers find their natural audience. Explore opportunities for personalization, quality detection, topic modeling, or even AI-assisted editorial curation - all grounded in improving understanding, not chasing engagement for its own sake. Work closely with design, product, and engineering partners to translate ambiguous user needs into well-framed ML problems. Drive the research. Lead with curiosity and precision. You'll design and interpret experiments, bring statistical rigor to our experimentation, and keep a critical eye on things like bias and spurious correlation in our thinking. Bring organizational leverage. Work across teams to ensure that ML improvements are well-integrated into the product, not off to the side. You'll regularly influence decision-making through cross-functional collaboration, helping product and engineering leaders spot where ML can create leverage and where it shouldn't. Own and continuously improve our recommendation systems. Evolve our two-tower retrieval and ranking stack, refine our feature set, and push on model quality, latency, and interpretability. Find new and innovative ways to use ML techniques to better serve our community of readers and writers. This might mean smarter spam and slop detection, writer quality modeling, or intelligent routing of human moderation. The goal: keep Medium a place where humans thrive, not bots. Positively contribute to the broader culture and data ecosystem at Medium. Mentor others, document your work with clarity, and help raise the bar for how we think about, design, and deploy ML systems. Share learnings generously and make the people and systems around you better. Attend Medium's twice-yearly, in-person offsites (hosted in locations around the U.S.). Skills, Knowledge and Expertise You've been designing and building software for at least 7 years, with at least 3 years focused on architecting and shipping consumer-facing ML models. You have experience integrating ML into end-user products (recommendation, ranking, personalization, moderation). You have a proven track record of developing and deploying ML models that deliver measurable business and user impact, not just theoretical gains. You embody the “applied” in applied ML: You enjoy the research, but love seeing models ship, move metrics, and make people's experiences better. You're fluent in Python and ML libraries such as TensorFlow, HuggingFace Transformers, and scikit-learn. You're comfortable taking models from notebook to production. It's a huge added bonus if you have experience with Apache Spark for distributed or large-scale training. You're an excellent collaborator, able to translate between data, product, design, and engineering worlds, helping non-ML partners see what's possible (and what's not). You're excited to be “the voice of ML” in business and product conversations. You're skilled at identifying and evangelizing high-leverage ML opportunities across the organization, from recommendation systems to new personalization or quality signals. You have hands-on experience with modern model architectures and techniques e.g., feature interaction modeling, advanced negative sampling and bias correction techniques, and efficient large-scale candidate retrieval. (Bonus) You're curious about content discovery, publishing, or online communities, and have a soft spot for writing, ideas, and helping great work get found. Nice to Haves Experience with modern recommender systems. Experience utilizing modern AI tooling to accelerate development efforts. A passion for online writing, publishing, or long-form content. Familiarity with Medium, as a reader, writer, or both! Benefits In addition to the new skills you'll pick up, here's what else you'll enjoy by working at Medium: Working with a fully distributed team: We're fully remote and have teammates across the U.S. & France. Healthcare benefits covered at 100% for employees and 70% for dependents. Generous parental leave policy. Mental health support through Talkspace. Financial wellness support through Northstar. Stipends for co-working, professional development, wifi, and a one-time home office bonus. Unlimited PTO and standard company holidays. A discounted Medium membership! At Medium, inclusion, diversity, and equity are core to how we work and what we build. We believe a more inclusive team creates a better product-one that's intuitive, thoughtful, and serves a wide range of users. We strive to foster a supportive, fun, and challenging environment where people from all backgrounds can thrive. We welcome applicants from all walks of life and strongly encourage those from historically underrepresented groups to apply. Our hiring process is built to ensure fairness and equal opportunity for everyone. Even if your experience doesn't match every requirement, we'd still love to hear from you-your perspective and passion matter more than checking every box. Learn more about our mission, operating principles, and culture: Yes to a diverse community Be part of a better internet Medium Rules Operating Principles Read about our story here. Please note: We've been made aware that our job postings may appear on third-party sites that are not affiliated with our company. To ensure your application is received and reviewed, please apply directly through our official Greenhouse careers page. We do not collect applications through external job boards or services that request your personal information outside of Greenhouse. Additionally we request that all applications and supplemental questions be filled out directly by applicants themselves without the use of AI assistance. Salary Range$250,000-$300,000 USDGDPR Notice We will process your personal data as part of our recruitment process, in accordance with the General Data Protection Regulation (GDPR). For details on how we use your data, including the legal bases for processing, how long we retain it, and your rights under GDPR, please refer to our Privacy Notice. We may retain your information for future job opportunities based on our legitimate interest in building a talent pool. You can object to this at any time by contacting us at *********************. CCPA Notice If you are a California resident, you have rights under the California Consumer Privacy Act (CCPA), as amended by the California Privacy Rights Act (CPRA). These include the right to know what personal information we collect about you, the right to request deletion or correction of your data, and the right to opt out of certain uses. During the hiring process, we may collect personal information such as your name, contact details, resume/CV, employment history, education background, and any information gathered through interviews or assessments. We may share this information with service providers who support our recruitment process, in compliance with CCPA/CPRA. This information is used solely for recruitment and hiring purposes. We do not sell or share your personal information as defined under CCPA/CPRA. Candidate data is retained for up to 48 months for our legitimate business purposes and in accordance with applicable laws. To exercise your rights or request more information, please contact us at *********************. This notice can also be found on our Privacy Notice.
    $68k-102k yearly est. Auto-Apply 35d ago
  • Associate Scientist II, Process Development - Downstream

    Forge Biologics

    Drug safety scientist job in Columbus, OH

    We are currently seeking an Associate Scientist II, Process Development - Downstream to join the Forge Biologics team. This is an exciting opportunity to assist in the execution of laboratory experiments and protocols for downstream process development efforts. The candidate will assist in process development protocols/studies to optimize procedures for unique viral vector platform process and to assist in the transfer of client programs. The Associate Scientist will work to meet production goals, notify management of any potential delays in the schedule, and make recommendations to resolve the issues. What You'll Do: Assist with overall maintenance of the production and testing facilities. This includes but may not be limited to performing quality systems checks, buffer preparation, autoclaving of media, packing of biohazard material, monitoring or sanitizing equipment, preparing facility for production campaigns, and periodic cleaning of incubators, centrifuges, FPLCs, biological safety cabinets (BSCs), and other equipment. Culturing cells, performing transfections and/or infections with seed vectors, harvesting and lysing cells, and purifying vectors using density gradients, FPLC, or other techniques Provide receipt and distribution of incoming raw materials for research, preclinical, and clinical manufacturing. Unpack reagents, maintaining proper cold storage, restock supplies in storerooms or laboratories. Quarantine and prepare incoming raw materials intended for preclinical or clinical manufacturing for inspection and release. Maintain proper inventories of raw materials and consumables. Prepare formulations and raw materials as specified in protocols without the introduction of contaminants. Prepare sterile reagents as dictated by procedures or management by filtration or steam autoclaving. Report any discrepancies from protocols/study procedures or any materials preparation problems to management. Package and ship finished product to clients in accordance with procedures and regulations. Assist in the training and direction of Associate Scientists What You'll Bring: Bachelor's Degree in Biology, Molecular Biology, Virology, Biochemistry or related discipline Practical experience with FPLC or other chromatography systems. Must be self-motivating, organized, and proactive. Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems. Ability to work hours necessary to support production and/or product transfer activities. Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and cleanroom gowning attire as needed. Preferred: Master's Degree in Biology, Molecular Biology, Virology, Biochemistry, or related discipline. Experience with pilot and large-scale FPLC systems Experience with other aspects of downstream purification (e.g. - clarification/filtration, TFF, etc.) Work Environment and Physical Demands This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned. Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Life at Forge We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by. HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key. OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback. PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies. ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals. We've Got You Covered We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable. Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents Competitive paid time off plan Annual bonus for all full-time employees 401(K) company match Fully-stocked kitchen with free food/drinks 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care Employee Assistance Program Wellness benefits (financial planning services, mental health counseling, employer paid disability) Onsite fitness facility Professional & Personal development resources
    $53k-79k yearly est. 13d ago
  • Associate Scientist I

    Us Tech Solutions 4.4company rating

    Drug safety scientist job in Columbus, OH

    **Main Responsibilities:** - Sensory Scientist with 1-2 years of experience to support sensory testing and product evaluation. - This role involves preparing and managing sensory panels, handling and presenting samples, and maintaining lab organization. - The candidate will assist in designing and executing sensory studies using basic scientific principles and experimental design. - Responsibilities also include collecting and organizing data, supporting analysis, and ensuring tests are conducted accurately and consistently. **Skills:** - Worked in Lab environments. - Background in food science, psychology, Sensory science or related field- Biology or chemistry (scientific principles) is preferred. - Strong attention to details - Strong communication both verbal and written. - Familiarity with sensory methods and lab environments - Experience with Compusense software is a plus **Education** : - Bachelors degree in any field related to Food science, Psychology, Sensory science, biology, Chemistry. **Additional** : Looking for 1-2 years experience **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (*********************************** . US Tech Solutions 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, or status as a protected veteran. **Recruiter Details:** Name: Rahul Singh Email: *****************************
    $47k-69k yearly est. Easy Apply 1d ago
  • Associate Scientist (JP9834)

    3 Key Consulting

    Remote drug safety scientist job

    Employment Type: Contract Business Unit: Pre-Pivotal DP Synthetic Enabling Technology Duration: 1+ year Rate: $20-22/Hr 3 Key Consulting is hiring an Associate Scientist for a consulting engagement with our direct client, a leading global biopharmaceutical company. Job Title: Project Manager - REMOTE - (JP9268) Location: Thousand Oaks, CA. (100% REMOTE) Employment Type: Contract Business Unit: Medical Device Supply and Raw Materials Duration: 1+ years (with likely extensions) Notes: Posting Date: 10/14/2021 3 Key Consulting is hiring a Project Manager for a consulting engagement with our direct client, a leading global biopharmaceutical company. Job Description: In this laboratory-based on-site position, you will work within a cutting-edge solid-state chemistry team to support drug development. You will perform several functions and work across Process Development sites as you use solid state characterization tools to derive knowledge that will help drive efficient development and scalable understanding of processes and products in client's small molecule pipeline. The ideal candidate would possess: Proficiency in solid state characterization techniques, such powder X-ray diffraction, particle analysis by laser diffraction, thermal analysis (TGA/DSC), optical microscopy, surface area measurement. Attention to detail, adaptability to new techniques and multiple tasks, ability to solve problem and meet deadlines, and effectiveness to work independently and as a team member. Strong computer skills in instrumentation and data processing in a client-server environment. Excellent communication (verbal and written) and organizational skills. Why is the Position Open? Planned project. Top Must-Have Skill Sets: Experience with solid state characterization techniques. 1-2 years experience Strong knowledge in physical and organic chemistry. Bachelors degree in chemistry or chemical engineering Good verbal and written communication skills Day to Day Responsibilities: Perform solid state characterization measurements and analyses. Design and conduct experiments for form screening and form characterization analysis by following instructions and guidance from project representatives. Interpret data, maintain timely documentation (i.e. electronic notebooks), and contribute to technical reports and presentations in a cross-functional team environment. Participate in lab housekeeping, maintain lab equipment and supplies, and comply with lab safety guidelines. May work occasionally on flexible schedule, i.e. starting early morning or finishing late evening, depending on the project need Basic Qualifications: B.S. with degree in Chemistry, Chemical Engineering, Materials Science, Pharmaceutical Science or related scientific background experience. Pharmaceutical/biotech industry experience preferred, but not required. Demonstrated knowledge of various solid-state characterization techniques such as XRPD, TGA, DSC, particle size, microscopy, surface area, DVS, etc. Good written and oral communication skills. Employee Value Proposition: Candidate would be interfacing with many function areas. Candidate would have a great connection to the pharm development. This is a great hands-on experience and position. Red Flags: No background in physical science No hands on experience with web chemistry labs Interview process: Phone screening followed by in-person interview. We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. hts reserved. Regards, 3KC Talent Acquisition Team
    $20-22 hourly Easy Apply 60d+ ago
  • Asst./Associate Scientist, Analytical Science

    Amplifybio, LLC

    Drug safety scientist job in West Jefferson, OH

    Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio! AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics. The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)- Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) - Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) - Amplify's Manufacturing Enablement Center. About ASET West Jefferson, OH: AmplifyBio's safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Among the investments that AmplifyBio has made to empower preclinical assessments of advanced therapies is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies AmplifyBio is currently seeking to hire an Assistant/Associate Scientist to join our growing Analytical Sciences team ! The Assistant/Associate Scientist is responsible for performing analytical testing using a variety of cellular and/or molecular biology analysis platforms. Level of position and title will be based on experience and will report to a supervisor or senior scientist of Analytical Sciences . What You'll Do Here: Perform work in a laboratory setting using a variety of cellular and/or molecular biology analysis platforms. Collect and review data using manual and/or electronic systems. Develop and maintain a good working knowledge of laboratory equipment and experimental procedures to perform assigned laboratory tasks. Communicates routine updates (including technical challenges) on assigned tasks. Recognizes deviations and unusual occurrences notifying responsible individuals promptly and contributes to corrective actions. Complete and maintain training to remain compliant with all regulatory and health/safety requirements. Train less experienced staff as needed. Assists other departments as needed. We Would Love to Hear from You If: Bachelor's degree in molecular biology, Biochemistry, Immunology, Molecular Genetics, or related field. A minimum of 1 year of related work experience in performing cell or molecular assay techniques (e.g., qPCR, dPCR, cytokine analysis, ELISA, PBMC isolation, flow cytometry). Excellent documentation, organization, communication (oral and written), multi-tasking and problem-solving skills. Ability to work independently and in a collaborative team environment. Ability to follow all appropriate regulatory requirements to ensure experimental data are accurately recorded and verified. Ability to work in a BSL-2 research laboratory environment which includes periods of bench-work, working in a bio-safety cabinet, and ability to wear respiratory protection. Must be willing to be immunized with licensed and FDA approved vaccines and medications recommended for persons at risk to occupational exposures. Must have the flexible schedule to accommodate non-standard work hours. Must be able to work more than 40 hours a week (including weekend and holidays) when needed to accomplish necessary tasks. Knowledge of Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58 for the conduct of nonclinical laboratory studies. At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law. Why You Will Love Working Here: We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program (did we mention we have an onsite gym with state-of-the-art equipment and ping pong table?), to financial planning and legal assistance, we make sure to take care of our own. Health, Dental, and Vision insurance that starts on your first day at AmplifyBio! Competitive Compensation Package We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy! Generous paid parental leave Wellness and Self-Care Programs 401(k) match Tuition Reimbursement EAP/work-life support system A fun work environment where everyone's voice matters! We are just getting started! More benefits on the way! An Opportunity to Change the World!!! When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.
    $53k-79k yearly est. Auto-Apply 60d+ ago

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