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  • GxP Product Manager

    Moderna 4.8company rating

    Moderna job in Cambridge, MA

    The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. This is a rare opportunity to join Moderna's Digital team as a key player in the development and lifecycle management of lab informatics platforms that directly impact global regulatory and clinical operations. Blending the strategic lens of a product manager with the precision of a GxP business analyst, this high-visibility role is central to building validated, compliant, and business-critical applications. You will work hands-on with Laboratory Information Management Systems (LIMS), data pipeline integrations, and regulatory reporting platforms to deliver user-centric solutions that scale with Moderna's scientific ambitions. You will lead multiple workstreams covering UX, architecture, integration, and validation, while collaborating across Analytical Development, Quality, QA, and business operations. You'll serve as the go-to expert for product capabilities, integration logic, data governance, and operational excellence. The role offers a front-row seat to digital transformation and proximity to next-gen technologies such as Generative AI tools that are beginning to shape the future of biopharma data landscapes. Here's What You'll Do Your key responsibilities will be: Serve as product owner for critical lab informatics platforms, particularly GxP-compliant LIMS and visualization/reporting tools. Lead the development and continual refinement of user stories and functional scope based on evolving business needs and KPIs. Drive sprint planning and backlog prioritization using agile methods tailored to validated system environments. Collaborate with business stakeholders across regulatory, clinical, and QA to ensure alignment and maximize value delivery. Translate complex system architectures and data flows into business-friendly narratives for decision-making and alignment. Lead application lifecycle and release management processes to ensure compliance with global regulatory standards (21 CFR Part 11, Annex 11, ALCOA+). Partner with engineering and validation teams to execute computer system validation (CSV) deliverables, including authoring test protocols and user requirements. Define success criteria and track measurable ROI of implemented solutions. Manage offshore and global teams, as well as vendor partners in regulated settings. Your responsibilities will also include: Maintain and govern digital platforms across their lifecycle to support operational excellence and system scalability. Author or contribute to impact assessments and validation deliverables (URS, FRS, IQ/OQ/PQ). Act as SME for platform integrations, user experience standards, and compliance impacts across digital tools. Contribute to both short- and long-term product roadmaps aligned with Moderna's digital and clinical strategies. Establish and maintain operational metrics and generate reports for senior leadership. Apply adaptive agile practices within a GxP environment to ensure rigorous but flexible product delivery. Support data governance initiatives in collaboration with business stakeholders. Participate in business case development with measurable ROI and value frameworks. Engage with Generative AI-enhanced solutions to further optimize platform performance and insight generation. The key Moderna Mindsets you'll need to succeed in the role: “We digitize everywhere possible using the power of code to maximize our impact on patients.” This role is at the core of that mindset. You will own and shape digital platforms that translate lab, quality, and regulatory requirements into powerful, compliant tools that drive Moderna's mission forward. You'll lead the charge in integrating intelligent digital solutions and begin to explore Generative AI's potential for unlocking faster, smarter insights. “We behave like owners. The solutions we're building go beyond any job description.” As the sole product lead for multiple mission-critical digital applications, you won't just deliver what's asked-you'll anticipate user needs, optimize system behaviors, and influence long-term strategy. This is a hands-on role where ownership, initiative, and accountability are the keys to success. Who We Are A highly-organized, data-driven systems thinker who understands the interdependencies between multiple platforms, diverse processes, cross-functional teams and how these impact enterprise data strategies and outputs Team player who is unafraid to ask the hard “what-if” questions (in the appropriate tone and forums) to probe on symptoms in order to get to the actual problem statement/root cause of what we are solving for You understand the criticality of a strong user experience to drive launch and adoption Excellent communicator with strong active listening skills and storytelling abilities, an empathetic approach and ability to rapidly align clear scope across diverse cross-functional global team processes Strong collaboration and relationship-building skills with a diverse set of business stakeholders and technical delivery teams You know when to dive into the deep details and when to pull back to provide a high-level view You speak these languages well and can effortlessly translate between them based on your audience: business, product, technical and data Ability to manage conflicting priorities and thrive in a fast-paced, dynamic environment with shifting priorities. Excellent time management skills and ability to swap between multiple hats in a fast-paced environment. You love having many hats…and know which one to wear when Here's What You'll Need (Basic Qualifications) The ideal candidate will have strong GxP Business Analyst skills and experience who made a successful transition to a Product Management role. Minimum 7+ years experience in GxP biotech/pharma space Minimum of 5+ years as a Product Owner/Product Manager in digital healthcare/biotech/pharma space with strong experience in delivering E2E data solutions and GxP reporting outcomes. Spotfire and Tableau experience highly desired. Minimum of 5+ years as GxP Business Analyst specializing in LIMS systems in biotech or pharma space. Labvantage 8.7 experience highly desired. Minimum of 3+ years of hands-on experience with GxP LIMS systems Strong experience in data lifecycles and data governance procedures Strong understanding of stability testing procedures, data and regulatory requirements to maintain stability testing compliance Expert in following tools and areas: JIRA for backlog management, refinement and sprint planning Confluence for version-controlled functional requirements and other key product documentation Validation documentation and SDLC processes Strong proficiency in the following tools and areas Excel, PowerPoint, Kneat 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 $145,900.00 - $234,200.00. 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 -
    $145.9k-234.2k yearly Auto-Apply 28d ago
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  • Executive Director, Research & Development Quality Assurance (RDQA)

    Moderna 4.8company rating

    Moderna job in Cambridge, MA

    The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna is solidifying its presence in Cambridge, Massachusetts. Our head office here is more than just a global administrative center; it is a vital part of our efforts in pioneering mRNA technology and engaging in meaningful collaboration with the area's renowned universities and research institutions. In Cambridge, we aim to harness the wealth of knowledge and innovative spirit this region offers to further our global mission in medicine and healthcare. We are actively seeking talented individuals who are motivated by innovation and committed to making a significant impact. Join us at our Cambridge location, where your contributions will be pivotal in advancing our groundbreaking work in mRNA medicines and improving global health outcomes. This is a critical leadership opportunity for a seasoned Quality executive to shape and drive Moderna's global R&D Quality strategy across all GxP domains. The Executive Director (ED), R&D Quality Assurance (RDQA), reporting to the Head of Quality, will set the strategic direction, governance model, and operational excellence framework for Quality within Research and Development. The ED will serve as Moderna's most senior QA leader across GCP, GLP, GCLP and GVP, embedding proactive quality principles into the full R&D lifecycle - from research through to late-stage development. This role partners closely with Clinical Development, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety. With a strong emphasis on leadership, innovation, and transformation, this position is accountable for cultivating a data-driven quality culture, hosting global regulatory inspections, and leading a high-performing QA team based in Cambridge. Here's What You'll Do: Your key responsibilities will be: Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna's entire development portfolio. Define and execute a robust, forward-looking quality strategy in alignment with global regulatory requirements and Moderna's innovation agenda. Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas. Embed risk-based quality management principles into study design, data generation, and vendor oversight practices. Serve as the Quality leader and Inspection Host during global regulatory inspections (FDA, EMA, MHRA), ensuring timely and effective resolution of findings. Drive modernization of vendor oversight and shared accountability models, elevating external partnership performance. Your responsibilities will also include: Build and lead a high-performing, solutions-oriented R&D QA team, rooted in scientific credibility and operational excellence. Enhance Quality Culture across R&D by promoting real-time quality management, early issue detection, and continuous feedback loops. Establish and track quality metrics and leading indicators that drive meaningful risk mitigation and compliance. Own the end-to-end quality lifecycle for deviations, CAPAs, issue management, regulatory intelligence, and inspection readiness. Oversee the Pharmacovigilance Quality System (GVP) including signal management, safety database validation, and global safety inspection preparation. Collaborate with Global Systems & Compliance to maintain a fit-for-purpose R&D Quality Management System (QMS) that supports innovation and agility. Monitor global regulatory intelligence and evolving external expectations, ensuring internal systems are updated accordingly. The key Moderna Mindsets you'll need to succeed in the role: “We behave like owners. The solutions we're building go beyond any job description.” In this executive role, you will serve as the quality conscience of Moderna's entire R&D pipeline - with ownership of not just systems and metrics, but the culture, strategy, and mindset needed to make quality a competitive advantage. “We digitize everywhere possible using the power of code to maximize our impact on patients.” This role has a unique opportunity to modernize quality oversight by leveraging digital tools, automation, and data-driven insights - from vendor performance analytics to proactive issue detection in the clinical and non-clinical space. Heres' What You'll Need (Basic Qualifications) Bachelor's degree in a life science or related field; advanced degree preferred. 18+ years of progressive Quality experience in the biopharmaceutical industry with deep expertise in GCP, GLP, GCLP and GVP and the ability to provide expert guidance on complex quality issues occurring in clinical trials, regulatory submissions, laboratories and PV and clinical safety. 15+ years' experience leading multifunctional quality organizations within the research and development sector, with proven excellence across all facets of quality management including experience developing and managing budgets and ensuring efficient allocation of resources to support both short-term initiatives and long-term organizational goals. Expertise to oversee comprehensive resource and staffing management, building high-performing teams and fostering a culture of continuous improvement and accountability. Experience in the development and execution of robust audit schedules, coordinating cross-functional efforts to ensure compliance with industry standards and regulatory requirements through proactive planning and collaboration. Demonstrated success in developing and executing global audit programs and hosting health authority inspections with a track record of positive outcomes. Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH and EU PV regulations/guidelines, including ICH E2 and EU PV legislation. Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH regulations, guidance and local legislation for clinical trials, including a ICH E6 (R3). Proven ability to collaborate and influence in a fast-paced, matrixed environment; strong cross-functional partnership skills with Clinical, Non-Clinical, PV, Regulatory, and Digital groups. Exceptional leadership and people-development skills, with demonstrated ability to build and inspire high-performing, geographically dispersed teams. Excellent strategic thinking, risk-based decision-making, analytical and communication skills Agile and growth mindset; thrives in rapid growth and embraces continuous improvement and innovation. 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 $224,900.00 - $404,600.00. 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-NH1 -
    $224.9k-404.6k yearly Auto-Apply 28d ago
  • Oncology Imaging & Biomarker Strategy Lead

    Regeneron Pharmaceuticals, Inc. 4.9company rating

    Boston, MA job

    A leading biotechnology firm is seeking a Clinical Imaging Scientific Director for Oncology to lead imaging strategy and execution in clinical trials. The ideal candidate will have a PhD and over 10 years of experience in clinical imaging, particularly in oncology, with significant expertise in PET imaging and regulatory engagement. This role requires collaboration with research teams and overseeing imaging project implementation, contributing significantly to oncology drug development. Comprehensive benefits are offered to eligible employees. #J-18808-Ljbffr
    $104k-139k yearly est. 5d ago
  • Senior Medical Science Liaison, Dermatology (Boston Metro)

    Johnson & Johnson 4.7company rating

    Boston, MA job

    Johnson & Johnson Innovative Medicines is recruiting for a Senior Medical Science Liaison, Dermatology to be based in the Boston, MA territory. This field‑based clinical role focuses on providing balanced, objective scientific information and education to health care professionals, building strong relationships with opinion leaders, and supporting company research initiatives. The position requires significant travel (estimated 80%) and collaboration across internal and external teams. Responsibilities Develop and execute a strategic territory plan, including in‑person and virtual engagements with health care providers and key opinion leaders. Respond to scientific queries and provide evidence‑based data, integrating real‑world evidence to inform clinical practice. Coordinate and support investigator‑initiated research, including site identification, issue resolution, and meetings. Lead at least one scientific or strategic project in Immunology, identifying educational gaps and elevating team knowledge. Provide regional support to enhance sales training initiatives and improve field personnel competencies. Maintain accurate administrative requirements (expense reporting, activity documentation) and comply with regulatory and health‑care guidelines. Qualifications Advanced medical degree (PharmD, PhD, MD, NP, PA) with a minimum of 3 years of relevant therapeutic area clinical experience. At least 3 years of MSL or related pharmaceutical experience, including significant presentation experience. Strong communication, stakeholder engagement, and scientific dissemination skills. Valid U.S. driver's license with a clean record and ability to travel 75‑80% of the time. Residence within the assigned Boston, MA territory. Preferred Knowledge of dermatology or related immune‑mediated disorders. Proficiency with Microsoft Office (Word, Excel, PowerPoint) and remote collaboration tools. Prior experience collaborating with medical affairs, R&D, or field teams. Salary & Benefits Base salary range: $137,000 to $235,750 per year. Eligible for an annual performance bonus and company vehicle through the Fleet Program. Benefits include medical, dental, vision, 401(k) retirement plan, short‑ and long‑term disability, and paid time off. Travel Estimated travel: 80% within the Boston region, with occasional out‑of‑region visits. Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other protected characteristics. #J-18808-Ljbffr
    $137k-235.8k yearly 3d ago
  • Strategic Accounts Lead - MedTech & Cardio Sales

    Johnson & Johnson 4.7company rating

    Boston, MA job

    A leading healthcare company is seeking a Manager for Strategic Accounts based in Boston, MA. This role involves driving business growth by building strategic relationships in the hospital sector and leading cross-functional teams. Candidates must have at least 5 years of sales experience in medical devices, particularly in the cardiovascular field. The position offers a competitive salary, benefits, and opportunities for significant impact within an innovative healthcare environment. #J-18808-Ljbffr
    $119k-153k yearly est. 3d ago
  • Director, Corporate Counsel - Privacy / Transactions

    Regeneron Pharmaceuticals 4.9company rating

    Cambridge, MA job

    Regeneron Pharmaceuticals is seeking a highly experienced transactions attorney for a pivotal role to serve as the liaison to the Regeneron Data Privacy Office. This position will act as a privacy expert within the Transactions & Contracts team offering guidance to colleagues on privacy law and ensuring that privacy provisions are seamlessly integrated into our contracts. The position involves drafting, reviewing, negotiating, and providing strategic counsel on a diverse portfolio of agreements across our innovative business units. Your expertise will be instrumental in advising the Transactions Team on complex privacy issues, requiring a deep understanding of life sciences, business transactions, and data privacy. We are looking for a candidate with exceptional drafting and negotiation skills, and a proven track record of progressive experience in contract law and data privacy. The ideal candidate thrives in collaborative settings, working alongside multiple stakeholders to provide comprehensive legal solutions that drive Regeneron's success. The role will be based onsite at our offices in Cambridge, MA or Sleepy Hollow, NY. This is not open to fully remote-based work arrangements. If eligible, we can offer relocation benefits. A typical day might include the following: Providing legal support for a particular area of business transactions, which may include research collaboration agreements, master services agreements, consulting services agreements, license agreements, data use agreements, laboratory services agreements and confidentiality agreements, among others. Maintaining subject matter expertise in data privacy laws and the Regeneron privacy policies and advising Transaction Law colleagues and clients on developments of importance. Providing ongoing one-on-one support to members of the Transaction Law team and coordinating with internal teams and external resources to negotiate and finalize data privacy language in third-party agreements. Responding to U.S. and ex-U.S. contracting questions. Managing updates to group's data privacy contracting playbook. Creating data privacy contracting tools and training materials. Managing office hours with internal business partners. Developing and training on privacy contracting tools and requirements. Acting as liaison for the Transactions Law Group with the Data Privacy Office on data privacy policy questions and approaches. This role might be for you if: You have the ability to work independently, while meeting aggressive deadlines and juggling multiple matters. You are able to maintain an objective perspective while developing and maintaining strong partnerships with key stakeholder / client organizations and protecting Regeneron's interests. You can work effectively and professionally with colleagues and clients at all levels of the organization and in a collaborative, team-oriented environment. You have the ability to effectively convey to, and respond to questions from, colleagues and key stakeholders, on data privacy law concepts. To be considered for this position you must possess a JD with excellent law school credentials. Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel is preferred. At least 7 years of legal experience at a law firm and/or in-house, with some biotech/pharmaceutical and/or health care experience is preferred. Solid understanding of contracts and related law. Experience with contracts involving data privacy and intellectual property. You should also have a high level of business acumen, excellent contract drafting and negotiation proficiency, exceptional oral and written communication skills and interpersonal and conflict resolution capability. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $202,000.00 - $336,600.00
    $202k-336.6k yearly Auto-Apply 60d+ ago
  • Senior Windows Infrastructure Engineer

    Moderna 4.8company rating

    Moderna job in Cambridge, MA

    The Role Moderna is expanding our footprint to deliver the greatest possible impact to people through mRNA medicines. Our Cambridge technology hub server team is responsible for the design, implementation, administration, and support of the server environments supporting our research and pharmaceutical production. This role requires deep expertise across all core Windows Server roles and features, including Active Directory, DNS, DHCP, Group Policy, and File/Print services. The ideal candidate is a hands-on technical expert who excels in troubleshooting, automation, and system optimization to ensure stability, scalability, and security across enterprise systems. We are seeking experienced engineers who embody the Moderna Mindsets and want to help transform patients' lives by building reliable, secure, and scalable systems. Here's What You'll Do Deploy, configure, and maintain Windows Server environments and build images (2016/2019/2022/2025). Perform advanced system troubleshooting and root cause analysis for performance, network, and authentication issues. Implement and manage Windows Server security baselines and patch management. Ensure high availability, scalability, and security of internal platforms. Create, maintain, and troubleshoot Group Policy Objects (GPOs) for user and computer configurations. Configure and maintain DNS, File and Print, Remote Desktop Services (RDS), Windows Failover Clustering, and Certificate Services (ADCS). Maintain accurate documentation, diagrams, and system inventories. Use PowerShell and automation tools to streamline operational and deployment tasks. Develop server and application implementation plans, custom scripts, and testing procedures to ensure operational reliability. Participate in on-call rotation and respond to escalated support incidents. Here's What You'll Need (Basic Qualifications) Bachelor's degree in computer science, engineering, or related field (or equivalent experience). 3-5 years of professional experience supporting Microsoft Windows Server environments. Strong understanding of Windows Server and all associated roles and features Proven ability to troubleshoot authentication, replication, network, and performance issues. Experience with patch management process and tooling, endpoint protection, and server hardening. Here's What You'll Bring to the Table (Preferred Qualifications) Microsoft certifications (AZ800/AZ801, SC300, MCSA, MCSE, or equivalent). Proven experience in Microsoft System Administration Experience working with vCenter and AWS. Proficient with Microsoft and third-party monitoring and management tools Experience in regulated environments (GXP, DISA-STIG, CIS, PCI, etc.) Ability to work independently, develop long term strategic Infrastructure enterprise goals. 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 $130,800.00 - $209,400.00. 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 -
    $130.8k-209.4k yearly Auto-Apply 35d ago
  • Research Associate/Engineer I, Technical Development (2026 Rotation Program)

    Moderna 4.8company rating

    Moderna job in Norwood, MA

    The Role is located in Norwood, MA and has a start date of August 3, 2026. The Technical Development organization at Moderna is looking for top talent in science and engineering to deliver on its mission to design manufacturing processes for mRNA medicines. This posting is for a full-time position in Moderna's Technical Development Rotation Program. Rotation Program participants will have an exciting opportunity to explore different areas of mRNA therapeutic development through completing three 6-month rotations in Technical Development. Participants will be part of high-performing project teams developing new manufacturing platforms to produce mRNA therapeutics and vaccines destined for clinical trials and commercial licensure. You will apply your educational background and learn new technical skills in the synthesis of mRNA, assembly of lipid nanoparticles, and formulation of drug products. Through completing an operational rotation, you will develop a deep understanding of how Technical Development's efforts enable the manufacture of mRNA medicines. Technical Development is based in Norwood, MA. Here's What You'll Do Work with a team of highly skilled experts to come up to speed on technology and techniques. Use laboratory, technical and communication skills to generate experimental results, perform data analysis, and document in formal reports including conclusions and recommended next steps. Perform process scale-up, support technology transfer and provide manufacturing support at internal Moderna, and external contract manufacturing sites. Participate in planning, design, execution, analysis of experiments and formal risk assessments to establish critical process parameters, and overall process control strategies. Optimize the impact of formulation and processing conditions on the stability of mRNA drug products and process intermediates. Review and share relevant academic literature and establish new collaborations with internal research and manufacturing groups. Create scaled-down models, and high throughput experimental setups for unit operations. Characterize mRNA and lipid nanoparticles through collaboration with the analytical team. Prepare technical reports and present finding in cross-functional meetings. Additional duties as may be assigned from time to time. Here's What You'll Need (Basic Qualifications) Bachelors or Masters Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biomolecular Engineering, Chemistry, Biochemistry, Biomedical Engineering, Biophysics, Biostatistics, Biotechnology, Mathematics, Molecular Biology, Pharmaceutical Science, Statistics, or a related field preferred. Strong fundamental scientific and engineering skills for the evaluation of experimental data Laboratory skills applicable to bioprocess development and analytical methods At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work. Here's What You'll Bring to the Table (Preferred Qualifications) GPA of 3.5 on a 4 scale or equivalent Demonstrated ability to work both independently as well as the ability to contribute to high performing teams. Excellent written and verbal communication skills. Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations (GxP, GMP, GLP) A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. 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 $63,200.00 - $100,900.00. 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. -
    $63.2k-100.9k yearly Auto-Apply 60d+ ago
  • Advanced Surgical Consultant - Mobile

    J&J Family of Companies 4.7company rating

    Danvers, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** MedTech Sales **Job Sub** **Function:** Technical Sales - MedTech (Commission) **Job Category:** Professional **All Job Posting Locations:** Alabama (Any City), Danvers, Massachusetts, United States of America, Mobile, Alabama, United States **Job Description:** **About Cardiovascular** Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This is a field-based role located in Mobile, AL in the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. We are searching for the best talent for Advanced Surgical Consultant. **Purpose:** Heart Recovery, a rapidly growing medical device company, is looking for a driven and results oriented Surgical Sales "Heart Team" Specialist. We are growing both our focus and device line-up in order to support Cardiac Surgeons and Heart Failure Cardiologists across the US. With our continued success, we are looking to expand our commercial team. You will work closely with our Surgical Account Managers and Commercial Sales and clinical team who will be responsible for driving growth across the US. Through our Impella product portfolio you will enable physicians and staff to recover hearts and save patients' lives. **You will be responsible for:** + Train, educate, and support combined CT/Heart Failure programs on the proper use of the Impella. + Full customer immersion (ie. input on patient selection and subsequent surgical support) within 5.5 sites to ensure optimal patient outcomes. + Device expertise and support on Impella to assist with the adoption of the full portfolio beyond 5.5 commercial launch responsibilities. + Surgical implant and unit support readiness including training and education at existing sites. + Internal collaboration with the Surgical Leadership Team, Training Team, Engineering Team, Marketing, Professional Education, Clinical, as well as with R&D. + Participate in On Call support rotation + Maintain contact with all customers to evaluate clinical and educational needs. + Performs device training on full Impella Device line-up. + Be a functional expert and provide advanced acumen on the durable, acute, and hemodynamic medical device landscape and best practices in the management of those devices. + Cultivates close relationships with strategic business partners and key opinion leaders. + Call point(s): Cardiac Surgeons, Heart Failure Cardiologists, OR teams, Intensivists, Perfusionists, and ICU/ Step Down Unit teams. **Qualifications / Requirements:** + Bachelors' Degree required; Registered Nurse First Assist (RNFA), Nurse Practitioner (NP), Surgical Physician's Assistant (PA), or Perfusionist licensure + Direct (at the table) experience in Cardiac Surgery/Perfusion, 5+ years preferred. + Direct patient management experience in one of the following scenarios: a cardiothoracic ICU caring for post-op tMCS (excluding IABP) or durable MCS (does not include experience as an Abiomed field clinical), or direct experience assisting in the CVOR required. + Confidence, expertise and, familiarity of cardiac surgery and OR protocol is required. + Willingness to travel/ cover multiple geographies required. + Up to 50%-overnight travel may be required depending on territory. + Previous experience with Abiomed Impella 5.5 required; other Cardiac medical devices highly desired. + Ability to drive patient outcomes required. + Conduct duties and responsibilities in accordance with all state and federal laws and regulations governing the medical device industry required. + A valid driver's license issued in the United States is required. The base pay for this position is $125,000. The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. This position is eligible for a company car allowance through the Company's FLEET program. **Benefit Information:** Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: + Vacation -120 hours per calendar year + Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year + Holiday pay, including Floating Holidays -13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year + Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child + Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year + Caregiver Leave - 80 hours in a 52-week rolling period 10 days + Volunteer Leave - 32 hours per calendar year + Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: + ********************************************* This job posting is anticipated to close on 11/28/2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:**
    $125k yearly 60d+ ago
  • Director, Therapeutics Translational Research

    Moderna 4.8company rating

    Moderna job in Cambridge, MA

    The Role: Moderna is pioneering the development of mRNA-based cancer vaccines and therapeutics, and we are seeking a Director of Target Profiling to focus on forward translation to stratify and/or identify patients for early clinical trials. This role is critical in ensuring an efficient and seamless transition between preclinical research and clinical development. In this role, you will lead a focused research team to envision, develop and implement integrated approaches to develop precision patient profiling methodologies, focusing on stage-appropriate companion diagnostics (CDx), biomarkers for disease monitoring, patient stratification, and assay development. Your work will enable informed product strategy decisions such as tumor-associated antigen (TAA) selection, indication prioritization, and disease tracking. By leveraging advanced technologies like flow cytometry, ct DNA sequencing, MRD assessments, and protein-based assays, you will help identify the right patients for therapeutic interventions, driving transformational drug development in the emerging oncology and autoimmune therapeutics pipelines. Here's What You'll Do: Develop and validate cutting-edge methodologies, including ct DNA, MRD, and protein-based assays, to monitor disease progression and therapeutic efficacy in a variety of clinical settings and disease indications. Lead the development of stage-appropriate CDx assays to enable precision patient profiling and inform strategies for therapeutic intervention. Manage the implementation of flow cytometry and other advanced profiling techniques to characterize and/or stratify patient populations effectively. Collaborate with Preclinical Program teams, Translational Medicine and Clinical Biomarker teams to define and implement comprehensive translational strategies to drive programs from concept to clinic. Stay at the forefront of scientific and technological advancements in precision targeting and companion diagnostics. Contribute to the broader translational research team strategy, fostering innovation and excellence. Oversee relationships with CROs and internal labs to ensure the timely completion of assay development, qualification, and validation studies, delivering high-quality data for translational research projects. Mentor and develop junior scientists within the translational research team, fostering a culture of scientific excellence and continuous learning. Act as a scientific liaison and thought partner for key internal and external collaborators, including development and regulatory colleagues, academic institutions, and industry collaborators in the oncology space. Contribute to the preparation of regulatory submissions, scientific publications, and presentations, effectively communicating translational research outcomes. Here's What You'll Need: Education: Ph.D. in a relevant scientific discipline (e.g., oncology, immunology, cancer biology, immune-oncology) with a minimum of 10 years of experience in translational research within the pharmaceutical or biotechnology industry, preferably in immune-oncology or autoimmune therapeutic areas. Experience: Understanding of therapeutic development strategies. Strong background in developing flow cytometry, ct DNA sequencing, MRD methodologies, and protein-based assays to inform clinical development. Excellent communication and collaboration skills, with experience working in cross- functional teams. A results-driven mindset, capable of thriving in a fast-paced, innovative environment. A passion for advancing precision medicine to improve outcomes for patients. Demonstrated ability to innovate translational approaches for novel therapeutic concepts or modalities (ideally including experience with cell therapy and cancer vaccine platforms). Experience with regulatory submissions and interactions with health authorities is highly desirable. Demonstrated success in developing and integrating companion diagnostics and disease monitoring tools into clinical development plans. Excellent project management and organizational skills, with the ability to manage multiple cancer vaccine projects simultaneously. Strong leadership and interpersonal skills, with the ability to influence and lead cross- functional teams. Demonstrated proficiency in effectively managing and developing direct reports Exceptional communication skills, both written and verbal, with the ability to effectively convey complex scientific information related to cancer vaccines to a variety of audiences. A strong publication record in peer-reviewed journals is preferred, particularly in the field of cancer immunotherapy or autoimmunity. This role is expected to be in office 70% of the time with flexibility to work from home up to 30% 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 $167,000.00 - $300,700.00. 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-NH1 -
    $167k-300.7k yearly Auto-Apply 60d+ ago
  • Senior Facility Specialist

    Johnson & Johnson 4.7company rating

    Danvers, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Environmental Health, Safety (EH&S) and Facilities Services (FS) Job Sub Function: Facilities Repair & Maintenance Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: About Cardiovascular Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for a Senior Facilities Specialist. Purpose: A Senior Licensed HVAC Technician is a seasoned professional responsible for installing, maintaining, troubleshooting, and repairing heating, ventilation, air conditioning, and refrigeration systems. They often lead complex projects, mentor junior staff, and ensure all HVAC systems operate efficiently, safely, and in compliance with relevant standards. You will be responsible for: * Install, service, and repair HVAC and refrigeration systems in commercial, industrial, or residential settings. * Diagnose and troubleshoot system malfunctions using diagnostic tools and techniques. * Perform routine inspections and preventive maintenance to optimize system performance. * Lead or assist with complex projects, upgrades, and system modifications. * Ensure all work complies with local, state, and national codes, along with safety standards. * Keep detailed records of service activities, system performance, and repairs. * Mentor or guide junior technicians, providing technical advice and training. * Respond promptly to emergency calls to restore HVAC functions. * Monitor system performance and implement improvements for energy efficiency and reliability. Qualifications/Requirements: * Proven experience as an HVAC technician, with demonstrated expertise in system installation and service. * Relevant certifications such as EPA Universal, NATE, or equivalent. * Strong knowledge of HVAC systems, refrigeration, electrical components, and controls. * Ability to read blueprints, schematics, and technical manuals. * Excellent troubleshooting and problem-solving skills. * Strong communication and leadership abilities. Desired Skills: * Ability to manage multiple projects and prioritize tasks. * Good customer service skills and professionalism. * Strong attention to safety protocols and detail-orientation. * 5-7 Years of commercial experience Work Environment: * Primarily works indoors and outdoors, often in challenging weather conditions. * May be on-call for emergency repairs and outside regular hours for project deadlines. Johnson & Johnson is 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $77,000-$124,200 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $77k-124.2k yearly Auto-Apply 45d ago
  • Director, Medical Affairs Lead - Haematology

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA job

    Are you ready to make a meaningful impact in the field of haem-oncology? At Regeneron, we are seeking a dedicated Medical Affairs Lead to be the driving force behind our haem-oncology program in multiple myeloma and lymphoma. As a pivotal member of our team, you will serve as the medical contact in-country, collaborating with internal teams and external stakeholders to advance scientific understanding, improve patient care, and ensure the success of our therapeutic strategies. Join us in shaping the future of haem-oncology while working in a dynamic and supportive environment. A Typical Day: * Represent Regeneron as the in-country medical contact for haem-oncology, engaging with medical societies, academic leaders, and thought leaders. * Collaborate with cross-functional teams, including clinical development, regulatory, market access, and commercial colleagues, to optimise strategic and tactical planning. * Manage and develop a high-performing haem-oncology medical team, ensuring compliance, training, coaching, and execution of initiatives. * Provide medical support for clinical development activities, such as identifying key investigators and supporting patient recruitment efforts. * Stay updated on scientific advancements and therapeutic developments in haem-oncology to enhance strategic decision-making. * Participate in scientific engagements and deliver impactful presentations to diverse audiences, including healthcare professionals and stakeholders. * Lead medical education initiatives, ensuring alignment with local needs and compliance with ABPI and IPHA codes. * Collaborate with global teams to prepare for product launches, market access strategies, and life cycle management initiatives. This Role May Be For You If You: * Are a physician (M.D.) or scientist (PhD) with expertise in haem-oncology and experience in Medical Affairs within the pharmaceutical or biotech industry. * Have a strong knowledge of ABPI and IPHA codes, coupled with experience supporting research and clinical development in the UK. * Excel at building relationships with key stakeholders, including thought leaders, and can cultivate trust through scientific expertise and follow-through. * Possess strong leadership skills, inspiring and motivating teams while fostering collaboration and inclusion. * Are proactive, resourceful, and thrive in a fast-paced, innovative environment. * Are skilled at juggling multiple projects, delivering actionable insights, and maintaining attention to detail. * Embody an entrepreneurial attitude and demonstrate a commitment to ethical and scientific standards. * Are fluent in English and willing to travel 30-50% of the time. To Be Considered: Applicants must hold an M.D. or PhD with expertise in haem-oncology and have substantial pharmaceutical or biotech industry experience in Medical Affairs. A thorough understanding of the UK healthcare environment and ABPI/IPHA codes is essential. Preferred candidates will have experience supporting clinical development in haem-oncology, a solid background in life-cycle product development, and a proven ability to work cross-functionally in matrix environments. Strong leadership, communication, and organisational skills are critical for success in this role. Join Regeneron and contribute to advancing haem-oncology care while working with a team of passionate professionals dedicated to innovation and patient outcomes. Apply today to make a difference! Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
    $108k-140k yearly est. Auto-Apply 38d ago
  • Technical Documentation Specialist

    Johnson & Johnson 4.7company rating

    Danvers, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Marketing Job Sub Function: Advertising & Promotions Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: We are searching for the best talent for a Technical Documentation Specialist. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This person will work closely with the IFU Operations team, Product Managers, and project originators across the enterprise to assist in global company growth by providing documentation that serves our customers and meets local, federal and international regulations and guidance. The Technical Documentation Specialist will prepare instructions for use manuals and other supporting documents that communicate complex and technical information to customers. This position has overall responsibility for producing and maintaining IFUs and ensuring the accuracy and visual quality of layouts, graphics, and copy. This position may also work with Regulatory, Advanced Clinical Training & Support, Product Management, Engineering, Quality, and other functions. Key components of the position include: * Adheres to brand and style guides * Creates new IFUs and updates existing IFUs based on drafts and redlines provided by project originators * Creates new graphics as required and stores appropriately in Veeva Vault * Creates translated sections of IFUs based on translated copy provided by certified translation vendor * Checks quality of own work including copy editing for grammar, punctuation, consistency, clarity, and style as defined by the company guidelines, and incorporates feedback from proofreaders * Receives task assignments in Roadmunk tool, dispositioning and updating status to ensure tracking is always up to date * Stores and distributes design files and final documents in accordance with operational processes and procedures * Prepares documents for printing, including reviewing proofs * Drafts and communicates release notes as IFUs are produced or updated * Exercises excellent service standards and maintains high customer satisfaction through resolving problems by explaining the best solution, expediting corrections or adjustments to provide resolution * Develops knowledge of other roles and responsibilities on the team, and provides support and coverage for other team members as needed * Participates in team and project meetings, and contributes to continuous improvement of processes, tools, and workflows as a member of a small but mission-critical team Qualifications: * Associate's or Bachelor's degree in graphic design or a related discipline * 1-3 years' experience with graphic design and technical document creation in a regulated product development environment * Demonstrated strong project management skills and multi-tasking capabilities * Strong attention to detail * Ability to clearly communicate ideas and information (oral and written) and work collaboratively. * Ability to adopt new tools and technologies * Adobe InDesign experience required Johnson & Johnson is 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is 79,000 to 127,650. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year. Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year. Holiday pay, including Floating Holidays - up to 13 days per calendar year. Work, Personal and Family Time - up to 40 hours per calendar year. For additional general information on Company benefits, please go to: - ********************************************* This job posting is anticipated to close on January 11, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Required Skills: Preferred Skills: Advertising, Analytical Reasoning, Brand Identity, Brand Positioning Strategy, Brand Recognition, Business Behavior, Communication, Content Marketing, Customer Intelligence, Data Analysis, Data Reporting, Design Mindset, Execution Focus, Financial Analysis, Integrated Media Planning, Leverages Information, Marketing Campaign Management, Organizing, Problem Solving, Researching, Sales Promotions
    $64k-88k yearly est. Auto-Apply 6d ago
  • Principal Human Factors Engineer, Abiomed

    J&J Family of Companies 4.7company rating

    Danvers, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** R&D Product Development **Job Sub** **Function:** Industrial Design & Human Factors **Job Category:** Scientific/Technology **All Job Posting Locations:** Danvers, Massachusetts, United States of America **Job Description:** Johnson & Johnson is hiring for a **Principal Human Factors Engineer ** **- Abiomed** to join our team located in Danvers, Massachusetts. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech **ABOUT US:** Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. **Patients First | Innovation | Winning Culture | Heart Recovery** **POSITION SUMMARY** Our Human Factors Engineers and Designers are focused on improving patient outcomes through better usability, rapidly developing next generation products for heart recovery by placing our users at the center of our design process. + We develop solutions that balance the needs of various users; surgeons, physicians, hospital staff, patients and caregivers. + Our team works across all global Abiomed platforms striving for best practice usability and true human centered design. **KEY RESPONSIBILITIES:** The Principal Human Factors Engineer will: + Influence the HF/Usability strategy and contribute to human factors efforts for programs from concept through post market support, supporting usability activities for all product lines and programs with minimal oversight. + Develop an understanding of intended use environments gained through good understanding of intended user types formed through interactions with users. + Work on problems of diverse scope that impact the broader program team and business and leads projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for creating risk mitigations and associated evaluations. + Mentor other engineers on project, and supervise/direct third party contractors/consultants; including reviews of deliverables to ensure accuracy + Network with key contacts outside own area of expertise, contributes to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development **REQUIREMENTS:** + University/bachelor's degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, or Equivalent; Post-Graduate Degrees (MS) are a plus. + Minimum of 8 years' work experience in human factors / usability engineering experience or equivalent experience in product development and customer interactions is required. Medical Device product development or experience working in a highly regulated industry is a strong plus. + Demonstrated proficiency with the human factors engineering process (research, planning, risk assessment, and regulatory submissions) and principles (task and use-related risk and root cause analysis methods). + Expertise in planning, executing (including moderation), documenting, and reporting usability testing including consolidating user feedback into concise, meaningful design insights and actionable recommendations. + Basic knowledge of anthropometrics, biomechanics, and physiology is preferred. + Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for improvement + In depth knowledge of FDA, ISO, AAMI, and other relevant usability regulations and standards. Knowledge of the ISO 14971 and IEC 62304 are a plus. + Fluent in English. German is an advantage. + Ability to travel up to 5%, domestic and international is required. Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace. Johnson & Johnson is 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $117,000 - $234,000 The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year. Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year. Holiday pay, including Floating Holidays - up to 13 days per calendar year. Work, Personal and Family Time - up to 40 hours per calendar year. For additional general information on Company benefits, please go to: - ********************************************* \#LI-Onsite **Required Skills:** Collaborating, Communication, Compliance Management, Innovation, Problem Solving **Preferred Skills:** Analytical Reasoning, Coaching, Concept Testing, Critical Thinking, Customer Intelligence, Human Factor Engineering, Industry Analysis, Organizing, Product Design, Product Improvements, Product Portfolio Management, Product Strategies, Product Testing, Prototyping, Research and Development, Risk Management, SAP Product Lifecycle Management, Technical Credibility **The anticipated base pay range for this position is :** US : $117,000.00 - $234,000.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $117k-234k yearly 54d ago
  • Process Development Senior Scientist - Attribute Sciences

    Amgen Inc. 4.8company rating

    Cambridge, MA job

    Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Senior Scientist - Attribute Sciences What you will do Let's do this! Let's change the world! This is an exciting opportunity to join the Amgen Biologics Pivotal Attribute Sciences team based in Cambridge, Massachusetts. In this role you will: * Lead late-stage protein structural elucidation and forced degradation studies using LC/MS workflows including reduced peptide mapping, disulfide mapping, and intact mass analysis; effectively communicate results to support regulatory filings. * Maintain, troubleshoot, and optimize high-resolution mass spectrometry methods; partner with instrument vendors and application specialists as needed to ensure reliable performance, consistent data quality, and high instrument uptime. * Develop, optimize, and qualify LC/MS and complementary LC-UV protein characterization methods to identify and monitor critical quality attributes; coordinate with program leads to identify and implement control strategies. * Lead training, qualification, and method transfer from our process development labs to our global quality network. * Interpret analytical results, author and review technical protocols/reports, and contribute to analytical CMC sections in regulatory filing documents including IND and BLAs. * Design automation-ready MS workflows including sample preparation, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency. * Build robust, inspection-ready LC/MS data analysis and reporting workflows (templates, QC checks, method trending) and ensure traceability and data integrity for CMC deliverables. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: * Bachelor's degree and 5 years of Scientific experience OR * Master's degree and 3 years of Scientific experience OR * Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] Preferred Qualifications: * Strong written and verbal communication skills, ability to support data-driven decision making with diverse internal and external stakeholders. * 5+ years of experience in industrial analytical laboratories supporting characterization of protein therapeutics, including partnering with QC and/or CMOs on method execution. * Deep LC/MS expertise in bottom‑up peptide mapping (including disulfide mapping) and intact mass analysis for biologics, with strong fundamentals in sample preparation, artifact control, and MS/MS data interpretation. * Hands-on experience with Thermo Orbitrap platforms (e.g., Q-Exactive, Exploris, Tribrids), including routine maintenance, calibration, and independent troubleshooting of common failure modes (sensitivity loss, spray instability, mass accuracy drift, carryover/contamination). Experience with Chromeleon and Biopharma Finder is a plus. * Strong RP‑UHPLC expertise (reversed‑phase method development and troubleshooting) to support peptide mapping/intact workflows (gradient optimization, column selection, carryover mitigation, pressure/peak‑shape troubleshooting). * Hands-on experience with laboratory automation including liquid handlers, pipetting robots, and automation software. * Familiarity with United States Pharmacopeia (USP), International Conference on Harmonization (ICH), and Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation. * Experience in authoring and reviewing regulatory submissions, especially module 3 (Quality) common technical documents for IND/BLA submissions. What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans * Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 136,692.00 USD - 164,965.00 USD
    $90k-116k yearly est. 12d ago
  • Distinguished Scientist, Clinical Research, Thoracic Malignancies

    Merck 4.6company rating

    Boston, MA job

    Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology. The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders. Specifically, the Executive Director, PDT Lead may be responsible for: + Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications. + Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations. + Planning clinical trials (design, operational plans, settings) based on these clinical development strategies + Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents + Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications + Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities. + Provide support for other therapeutic areas regarding clinical issues related to oncology compounds. The Executive Director, PDT Lead may: + Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects. + Supervise the activities of entire Clinical Teams in the execution of clinical studies. + Will report to and work collaboratively with the Section Head to promote the development strategy of the company on the indication of interest. + Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Section Head in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. The Executive Director is responsible for maintaining a strong scientific fund of knowledge by: + Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies + Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs + Establishing communications with prominent clinical investigators in their field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs + Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility. To accomplish these goals, the Executive Director, PDT Lead may: + Author detailed development documents, presentations, budgets, and position papers for internal and external audiences + Facilitating collaborations with external researchers around the world + Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects. **Education:** M.D or M.D./Ph.D. **Required Experience and Skills:** + Must have experience in industry in the field of Thoracic Oncology + Minimum of 3 years of clinical medicine experience + Minimum of 5 years of industry experience in drug development + Demonstrated record of scientific scholarship and achievement + A proven track record in clinical medicine and background in biomedical research is essential + Strong interpersonal skills, as well as the ability to function in a team environment, are essential. **Preferred Experience and Skills:** + Board Certified or Eligible in Oncology (and/or Hematology) + Prior specific experience in clinical research and prior publication **Required Skills:** Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Trial Planning, Clinical Trials, Cross-Cultural Awareness, Cross-Functional Teamwork, Drug Development, Ethical Standards, Medical Research, Oncology, Pulmonology, Regulatory Requirements, Research Methodologies, Scientific Consulting, Scientific Leadership, Scientific Research, Strategic Leadership **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $310,900.00 - $489,400.00 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 employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Hybrid **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 01/30/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381175
    $105k-154k yearly est. 4d ago
  • Commercial Lines - Associate Underwriter - New England

    Johnson & Johnson 4.7company rating

    Burlington, MA job

    Job DescriptionDescription: Assist the Underwriting Team in account maintenance while learning various underwriting tasks necessary for advancement. Job Responsibilities: • Ordering, analyzing, and interpreting inspections on accounts written • Navigating and understanding numerous company manuals • Processing policy audits. • Quoting, entering & binding Renewal accounts with New Business as tasked • Contributes to organization effectiveness by identifying short-term and long-range issues that must be addressed; providing information and commentary pertinent to deliberations; recommending options and courses of action; implementing directives. • Maintains inter- and intradepartmental workflow by fostering a spirit of cooperation • Maintains professional underwriting and technical knowledge by attending educational workshops • Adhere to Minimum Company service standards, going above and always striving to be better than the norm • Assist with creating and implementing Standard Operating Procedures for the department processes and training team members • Contributes to team effort by accomplishing various tasks as they are assigned • Pursue education to enhance industry knowledge by completing: • AICPCU courses: Program in General Insurance (INS); Associate in Insurance Services (AIS) and Associate in Commercial Underwriting (AU) • Travel as deemed necessary by the Manager, to both agencies & companies • Other duties as assigned Education and Work Experience: • 2-year degree in General Business or related field, preferred but not required • Minimum of 2 years experience in Insurance or related field preferred Knowledge Skills & Abilities: • Confidentiality • Analytical Skills • Research Skills • Attention To Detail • Decision-Making • Coordination • Teamwork • General Math Skills Typical Physical Demands: • Must be able to lift to 25 pounds; must be able to sit for long periods of time Requirements:
    $100k-126k yearly est. 7d ago
  • Principal Firmware Engineer, Motor Control, Abiomed

    J&J Family of Companies 4.7company rating

    Danvers, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** R&D Product Development **Job Sub** **Function:** R&D Software/Systems Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Danvers, Massachusetts, United States of America **Job Description:** Johnson & Johnson is hiring for a **Principal Firmware Engineer, Motor Control - Abiomed** to join our team located in Danvers, Massachusetts. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech **ABOUT US:** Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. **Patients First | Innovation | Winning Culture | Heart Recovery** **Responsibilities:** + Lead design, development, and maintenance of embedded software systems. + Provide technical guidance and project leadership to engineering teams. + Collaborate with cross-functional teams to define system requirements and architecture. + Develop unit tests and firmware/hardware integration. + Design and implement firmware builds; oversee board bring-up and integration. + Collaborate with hardware, product, and manufacturing teams on electro-mechanical requirements. + Develop control strategies (PI/PID, PWM, signal processing) for precise system operation. + Ensure compliance with IEC 62304, FDA design controls, and other applicable regulatory standards. + Develop and maintain automated test frameworks, including hardware-in-the-loop (HIL) setups. + Understand schematic designs; participate in team meetings. **Qualifications:** + Bachelor's or Master's in Computer Science, Electrical/Computer Engineering, or Embedded Software Engineering. + 10+ years in embedded systems, low-level firmware on STM32/ARM Cortex or ESP32, + Strong Experience with RTOS or bare-metal ARM environments. + Strong C/C++ skills, microprocessor optimization, threading, and software design principles. + Experience with UART, I2C, SPI, Wi-Fi, BLE, CAN, source control, and embedded build systems. + Strong troubleshooting, problem-solving, and documentation skills. + Experience with BLDC Motor Controls, (FOC, DTC, PAM) + 5+ years of Medical Device development experience **Preferred:** + Hands-on prototype work and functional verification for mechatronics products. + Experience with contract manufacturing, PCB design/validation, and lab equipment. + Experience with in-circuit emulators, JTAG debuggers and laboratory test equipment such as oscilloscopes etc. + Knowledge of regulatory (FDA, EPA) and quality processes. + Experience with software configuration management tools for source code control (Git), issue tracking (Jira), requirements management (JAMA) + Experience with medical device standards including IEC 62304, 60601, ISO 14971, 13485 Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace. Johnson & Johnson is 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. **Required Skills:** Collaborating, Design Mindset, Leadership, Process Oriented, Software Testing **Preferred Skills:** Coaching, Critical Thinking, Innovation, Model-Based Systems Engineering (MBSE), Organizing, Project Management, Report Writing, Requirements Analysis, Research and Development, Researching, SAP Product Lifecycle Management, Scripting Languages, Software Acquisitions, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC), Technologically Savvy, Training People **The anticipated base pay range for this position is :** $117,000 - $201,250 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $117k-201.3k yearly 41d ago
  • Sr Electronics Production Engineer

    Johnson & Johnson 4.7company rating

    Danvers, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Supply Chain Engineering Job Sub Function: Manufacturing Engineering Job Category: Scientific/Technology All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: About Cardiovascular Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for Sr. Electronics Production Engineer Purpose: This role will drive the scale-up and production of a complex electro-mechanical medical device used in life-saving cardiac support therapies. This role will own scale-up activities, validations, root-cause investigations, safety and regulatory compliance, and continuous process improvement with a focus on cost savings and robust, repeatable manufacturing processes. You will be responsible for: * Scale-Up & Design Transfer * Lead scale-up from pilot to full-scale production, including process development, equipment qualification, line layout, and work instructions. * Collaborate with R&D and Quality to ensure smooth design transfers and robust manufacturing readiness. * Validation & Verification * Plan and execute IQ/OQ/PQ activities for equipment, processes, and software where applicable. * Develop and approve validation protocols and reports; ensure traceability to user needs and regulatory requirements. * Root Cause Investigation & CAPA * Lead root-cause analysis for yield loss, quality escapes, and process deviations using structured problem-solving methods. * Implement corrective and preventive actions (CAPA), verify effectiveness, and close with data-driven evidence. * Safety & Regulatory Compliance * Ensure manufacturing activities comply with EHS standards and device safety requirements. * Maintain alignment with regulatory expectations (e.g., FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as needed. * Process Improvement & Cost Savings * Identify and execute Lean/Six Sigma projects to improve throughput, reduce cycle times, increase yield, and lower cost per unit. * Apply statistical methods (DOE, SPC, MSA, Cp/Cpk analysis) to optimize processes and sustain gains. * Quality Systems & Documentation * Maintain and improve documentation: SOPs, work instructions, MBR/Device History Records, change controls, and validation artifacts. * Develop and manage PFMEA, Control Plans, and ongoing quality checks to ensure product reliability. * Production Support * Provide hands-on troubleshooting on the manufacturing floor; drive standard work, line balancing, and equipment optimization. * Monitor key production metrics and implement actions to meet targets for quality, cost, and schedule. * Cross-Functional Collaboration * Partner with Quality, Regulatory, Supply Chain, Manufacturing, and R&D to align on program milestones, risk, and resource needs. * Mentor and coach junior engineers and technicians; contribute to a culture of continuous improvement. Qualifications / Requirements: * Bachelor's degree in Engineering (Electrical, Mechanical, Biomedical, Industrial, or related). Master's degree strongly preferred. * 6-10+ years of manufacturing engineering experience in electronics or medical devices (device hardware, electronics assembly, or related fields). * Working knowledge of FDA QSR/21 CFR Part 820 and ISO 13485. Experience supporting or leading design transfers, validation activities, and quality systems in a regulated environment. * Proficient in DOE/DOE-based experiments, statistical process control (SPC), capability analyses (Cp/Cpk), MSA, and root-cause analysis methodologies. * Experience with process validation (IQ/OQ/PQ) and risk-based approaches to manufacturing. * Familiarity with PCB/SMT assembly, soldering, testing, electronics packaging, and related manufacturing processes. * Experience with change control, CAPA, PFMEA, control plans, and documentation management. * Excellent problem-solving, communication, and project-management skills. * Ability to work cross-functionally, influence without authority, and manage multiple priorities in a fast-paced environment. Johnson & Johnson is 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LIOnsite Required Skills: Preferred Skills: Accelerating, Coaching, Critical Thinking, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Performance Measurement, Product Design, Program Management, Project Engineering, Project Schedule, Risk Compliance, Robotic Automation, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy The anticipated base pay range for this position is : $94,000.00 - $151,800.00 Additional Description for Pay Transparency: $91,000 - $147,200 This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year Please use the following language: For additional general information on Company benefits, please go to: - *********************************************
    $94k-151.8k yearly Auto-Apply 39d ago
  • Director, External Innovation, R&D Data Science

    Johnson & Johnson 4.7company rating

    Cambridge, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Project/Program Management Group Job Sub Function: R&D Project Management Job Category: Professional All Job Posting Locations: Cambridge, Massachusetts, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine The Director, External Innovation, R&D Data Science, External Innovation will drive the identification, assessment, and execution of strategic AI/ML partnerships that deliver measurable impact across Johnson & Johnson Innovative Medicine (JJIM) R&D. This role is accountable for leading the development of partnerships: producing high-quality diligences, landscape analyses, and partnership assessments that inform and enable decision-making across the R&D value chain, focusing on technologies that apply cutting-edge, multimodal AI/ML to extract insights from generative and agentic AI and complex biological datasets-including genomics, proteomics, transcriptomics, imaging, scientific literature, and emerging data modalities. The role requires deep "bilingual" capabilities across computational and scientific topics, and well as excellent strategic, operational, and communication skills. This position will be based in J&J's Innovation Center in Cambridge, Massachusetts. Summary * Landscape and assess: Conduct rigorous landscaping of external AI/ML capabilities, producing structured assessments that map strategic relevance to JJIM R&D priorities, delivering fit-for purpose landscape reports and assessments * Diligence and partnership development: Lead and participate in end-to-end diligence processes-including scientific scoping, technical evaluation, and business analysis-to support partnership formation with high-impact external entities, delivering detailed diligence briefs and advancing and leading the development of strategic partnerships with transformative potential * Partnership management and oversight: Manage, monitor, and evaluate ongoing strategic partnerships, ensuring delivery against research objectives and business milestones * Strategic contribution: Contribute to JJIM's AI/ML strategy by synthesizing insights from external engagement into actionable recommendations. Actively collaborate with External Scientific Innovation as a member of one of J&J's regional Innovation Centers. Responsibilities: * Deliver comprehensive landscape reports and structured assessments of external AI/ML capabilities (including generative AI) relevant to JJIM R&D priorities. * Lead end-to-end diligence processes-scientific scoping, technical evaluation, and business analysis-to support partnership formation with high-impact external entities. Produce detailed diligence briefs and advance strategic partnerships in collaboration with SMEs, transaction teams, and other stakeholders. * Alliance manage and oversee execution of ongoing strategic partnerships, ensuring delivery against research objectives and business milestones. Provide direction, monitor progress, and generate periodic evaluation reports. * Contribute to JJIM's AI/ML strategy by synthesizing insights from external engagement into actionable recommendations. Collaborate with External Scientific Innovation team at regional Innovation Center Requirements * PhD preferably in Computer science, AI/ML, Statistics, biomedical engingeering, Machine Learning & Artificial Intelligence, Physics, Mathematics, Bioinformatics, Computational Biology, Biology or a related discipline * 8yrs + in related work experience * Proven track record in developing and scaling AI/ML solutions, especially generative models, in a start-up, industrial, enterprise setting * Strong foundation in computer science, with hands-on experience in model architecture, deployment, and performance optimization. * Exceptional strategic thinking, communication, and stakeholder management skills. * Experience working across scientific and technical domains, with the ability to translate complex technical concepts into actionable business strategies. * Experience developing strategic partnerships * Experience in healthcare and/or life sciences * Deep knowledge and expertise in the use of AI/ML for research and discovery within a pharma * Exceptional strategic thinking, communication, and stakeholder management skills. * Experience working across scientific and technical domains, with the ability to translate complex technical concepts into actionable business strategies. * Experience developing strategic partnerships Johnson & Johnson is 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LI-GR #LI-Hybrid #JRDDS #JNJDataScience #JRD Required Skills: Preferred Skills: Agility Jumps, Business Alignment, Continuous Improvement, Mentorship, Performance Measurement, Process Control, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Reporting, Project Schedule, Quality Control (QC), Research and Development, Risk Management, Tactical Planning, Technical Credibility The anticipated base pay range for this position is : $164,000 - $282,900 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $164k-282.9k yearly Auto-Apply 30d ago

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