Senior Software Engineer - Full Stack Emulate, Inc.
Emulate, Inc. 4.3
Emulate, Inc. job in Boston, MA
Role Description
The Senior Software Engineer (Full Stack) designs, develops, and operates software that connects our scientific instruments with cloud services and user-facing applications. You will work across the stack-front end (TypeScript/React), back end (Go services/APIs), data and messaging, and integration with instrument software-to deliver reliable features that drive scientific workflows and insights. You'll collaborate with Frontend, Backend, DevOps, and Instrument engineering to “connect the dots” across our architecture and translate user and system requirements into high-quality, validated software.
This role reports to the Director, Software Engineering within the Platform Products department. You will lead design reviews, improve our tooling and paved roads, and help us move faster with confidence. This position is hybrid with an expectation of at least four days per week in the Boston office.
Key Responsibilities
Lead end-to-end delivery of features that span embedded firmware and ROS/ROS 2 nodes: requirements, design, implementation, verification, release, and sustaining.
Own end-to-end feature delivery across web front end, back end services, and instrument integrations: requirements → design → implementation → testing → release → operations.
Partner with Product, Scientists, and cross-functional stakeholders to clarify requirements and translate them into epics, stories, and acceptance criteria.
Design and build secure, scalable APIs (REST/gRPC) and front-end experiences that are resilient, accessible, and observable.
Collaborate with instrument and embedded teams to enable robust data and control pathways between devices, desktop utilities, and cloud applications.
Improve our infrastructure, tooling, and developer experience (CI/CD, testing strategy, monitoring, documentation).
Conduct design and code reviews; uphold engineering best practices, documentation standards, and validated change control.
Maintain high bar for security and privacy across the stack; contribute to threat modeling and remediation.
Create and maintain technical documentation that enables repeatability, auditability, and future development.
Qualifications
B.S. or M.S. in Computer, Electrical, Robotics, Mechanical Engineering
4+ years of professional software engineering experience (senior-level scope and autonomy; experience leading multi-component projects).
Experience building systems that interact with cloud services and APIs and deliver production web applications.
Strong engineering fundamentals and SDLC practices (requirements, design, testing, CI/CD, observability, incident response).
Working knowledge of software security requirements and common frameworks; ability to design with security in mind.
Excellent communication skills; able to collaborate with Scientists, Product, and multi-disciplinary engineering teams.
Hybrid work: able to be onsite in Boston at least 4 days/week.
Our stack, apps, and environment
Front end: JavaScript/TypeScript, React web applications.
Back end: Go services/APIs (e.g., Echo), REST/gRPC; event-driven patterns.
Desktop: Electron/JavaScript (e.g., UtilityHub for logs/firmware updates).
Cloud: AWS (ECS, RDS, S3); infrastructure and CI/CD tooling.
Data: Relational and non-relational stores (e.g., MongoDB, Elasticsearch).
Messaging/streaming: MQTT, Kafka; integration with connected instruments.
Domain: Scientific instrument and data-analysis applications; life-sciences workflows.
Ideal but not required
Experience collaborating with embedded/firmware teams (C/C++, RTOS) and integrating device protocols.
Experience with ROS
Strong testing practices across unit, integration, contract, and end-to-end; familiarity with validated environments.
Performance profiling, accessibility, and usability best practices on the front end.
Observability (metrics, logs, traces) and SLO-oriented operations.
Equal Opportunities
Emulate is an Equal Employment Opportunity Employer that is committed to diversity, equity, and inclusion. We take unbiased action to offer employment and advancement opportunities to all applicants, without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or ability status. Our methods for hiring include ensuring that all available opportunities are fairly promoted - via online globally available channels - in a manner accessible to all potential applicants.
About Emulate, Inc.
Emulate, Inc. is the pioneer of Organ-on-a-Chip technology, enabling researchers to accurately replicate human tissue function and disease biology through next generation in vitro models. From target discovery to IND submission, Emulate aims to ignite a new era in human health research-one that reduces animal testing, cuts drug development costs, and accelerates the delivery of life-saving treatments. Emulate's Organ-Chip platforms, consumables, and organ models help the world's leading pharmaceutical, biotech, and academic teams generate human-relevant data that advance safer, more effective therapies. Learn more at *******************
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$102k-126k yearly est. 3d ago
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Oncology Imaging & Biomarker Strategy Lead
Regeneron Pharmaceuticals, Inc. 4.9
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.
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$104k-139k yearly est. 4d ago
Principal Research Associate, Analytical Development
Moderna 4.8
Remote or Norwood, MA job
The Role: Reporting to the Head of the Product Characterization group, the individual in this role will coordinates characterization and comparability studies to support advancement of Moderna's pipeline, including commercial products. The incumbent should be familiar and have hands-on experience with most of the routine biochemical and biophysical characterization techniques used for RNA structural characterization, including mass spectrometry, spectroscopy, calorimetry, liquid chromatography, ELISA, light scattering and next generation sequencing. Demonstrated writing skills are required for protocol drafting and report compilation. Polished communication skills are essential considering that the incumbent will regularly interact with other RAs and Scientists within the Analytical Development, Analytical Technical Operations and Process Development teams. The individual will present scientific findings/results internally or externally. The individual will also evaluate new technologies, optimize methods and write methods SOPs.
Here's What You'll Do:
Draft testing protocols and compile characterization reports in support of regulatory filings
Coordinate sample generation and sample submissions for partner groups
Execute testing for various characterization assays including calorimetry, spectroscopy, light scattering and next generation sequencing
Perform data analysis and data trending utilizing good documentation practices
Record and communicate findings, present results at internal or cross-functional meetings
Write/Revise SOPs related to job function
Collaborate with other members within the with R&D departments throughout the company
Perform general laboratory support activities including equipment maintenance and housekeeping
Be accountable for project success and results delivery
Here's What You'll Bring to the Table:
BS with at least 4 years of industry experience, or MS with at least 2 years of industry experience (Biophysics, Chromatography, Biochemistry, Molecular Biology, or related science),
Experience in performing biophysical characterization with focus on mRNA structural characterization
Experience with spectroscopy and calorimetry
Excellent writing and documentation skills
Excellent interpersonal and collaborative skills
Ability to work independently and effectively in a highly dynamic environment
This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.
At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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$89.9k-143.8k yearly Auto-Apply 60d+ ago
Quality Assurance Manager
Regeneron Pharmaceuticals 4.9
Uxbridge, MA job
At Regeneron, we are dedicated to transforming lives through science and innovation. We believe in fostering a culture of collaboration, excellence, and continuous development. We are looking for a dedicated Manager QA to join our team in Uxbridge, UK. As a key member of the Quality Assurance Distribution (QAD) team, you will play a vital role in overseeing quality operations, managing storage and distribution activities, and ensuring compliance with regulatory requirements across the UK and European markets. This is your chance to create a meaningful impact on the quality and supply of life-saving products.
A Typical Day:
As the Manager QA, you will:
* Fulfill Responsible Person (RP) duties to ensure compliance with the Wholesale Dealers Authorisation (WDA) licence requirements.
* Oversee quality operations for distributor markets and marketing authorisation holder (MAH) activities.
* Manage storage and distribution activities in the UK and European markets to ensure smooth product supply.
* Support inspection readiness programs for Regeneron UK and affiliates.
* Author and approve quality-owned Standard Operating Procedures (SOPs) for the QAD team.
* Investigate and resolve temperature excursions in the UK and global markets, implementing corrective and preventive actions (CAPAs).
* Collaborate with distributor market partners to ensure effective due diligence, qualification, and relationship maintenance throughout the product life cycle.
* Provide subject matter expertise and lead quality assurance initiatives for product launches into new markets.
This Role May Be For You If:
* You thrive in dynamic environments and enjoy managing quality operations for complex supply chains.
* You have a keen eye for detail, ensuring compliance with European Good Distribution Practice (GDP) and The Human Medicines Regulations 2012.
* You excel at building and maintaining effective partnerships with vendors and distributors.
* You are passionate about ensuring quality and regulatory compliance in pharmaceutical distribution.
* You are skilled at conducting audits, managing deviations, and implementing CAPAs.
* You are motivated by opportunities to contribute to product launches and supply chain projects.
To Be Considered:
You must have a Life Science degree, ideally in Chemistry or Pharmaceutical Science. Experience as a named Responsible Person (RP) on a licence (preferred). You have a strong knowledge of Quality Management Systems and their application in pharmaceutical or similar industries. You are familiar with the virtual supply chain environment and management of commercial products through the supply chain. Preferred qualifications include experience in audit management, vendor/customer management programs, document control, and pharmacovigilance systems.
At Regeneron, we are committed to encouraging a diverse and inclusive work environment. If you are ready to take on an impactful role in quality assurance, we encourage you to apply today!
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.
$115k-144k yearly est. Auto-Apply 16d ago
Scientist, Platform and TA Bioinformatics
Moderna 4.8
Remote or Cambridge, MA job
The Role
Moderna is seeking an exceptionally talented and highly motivated computational scientist with RNA biology background to work as part of a highly collaborative, multi-disciplinary, and fast-paced team. The successful candidate will develop and apply novel algorithms to design and optimize therapeutic mRNAs. Leveraging state-of-the-art bioinformatics, optimization, and machine learning approaches, this role directly contributes to advancing Moderna's mRNA design and engineering platform across multiple therapeutic areas.
The ideal candidate has a deep foundation in algorithm development, demonstrated through peer-reviewed publications, and experience applying machine learning and deep learning to problems in RNA or related molecular systems. This position has significant visibility and potential for growth in a dynamic organization.
Here's What You'll Do
Develop and apply novel combinatorial optimization algorithms to solve the needs and challenges specific to developing mRNA medicines
Work with RNA biologists, the high throughput screening team, and the NGS team to acquire appropriate datasets to train, build, refine machine learning models
Utilize deep understanding of scientific literature and concepts to drive innovation for mRNA design
Contribute to scientific and strategy discussions to advance and enhance the Moderna mRNA Platform
Maintain accountability for project success and result delivery
Communicate research findings to both technical and non-technical collaborators internally and externally
Here's What You'll Need (Basic Qualifications)
Ph.D. in Computer Science, Bioinformatics, Computational Biology, Statistics, Physics, or related field with post-doctoral training
Algorithm development experience required
Experience applying machine learning and deep learning models required
Here's What You'll Bring to the Table (Preferred Qualifications)
Experience with applications in RNA biology
Familiar with RNA secondary structure prediction tools and principles
1+ year experience in industry
Experience analyzing NGS data from chemical probing experiments, e.g. SHAPE
Experience with programming or scripting language (multiple preferred), e.g. Python, R
High performance computing in a distributed/cloud environment, e.g. AWS
Software development best practices, including agile, version control, unit and integration testing, documentation, and deployment
Ability to manage multiple concurrent, fast-paced projects and to work with collaborators from both wet lab and dry lab
An established record of innovative research achievements in machine learning/bioinformatics reported in top-tier journals and patent applications
Excellent written and oral communication skills
Positive team building and teamwork skills: innate ability to influence, lead and inspire people, within function and beyond functional/company boundaries
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 $121,600.00 - $194,500.00. 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.
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$121.6k-194.5k yearly Auto-Apply 36d ago
Chromatography Expert
Merck 4.6
Bedford, MA job
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Chromatography Expert
Your role: We are seeking a Chromatography Expert with an engineering background to support Protein A chromatography adoption by our clients. This is a customer facing role as part of a global Protein A focused team, where you will work in close partnership with MilliporeSigma's Account Managers to cater to client's technical needs which may include direction on PD trials and optimization, pilot and process-scale runs, column packing guidance, and troubleshooting issues that arise during operations.
You will serve as a key technical contact supporting biopharmaceutical clients with critical chromatography purification projects. Your responsibilities are to:
· Provide expertise to support clients with process development, scale-up, and implementation of JSR chromatographic resin used for antibody purification, via remote consultation or on-site support.
· Design and execute experimental protocols to understand process sensitivity and troubleshoot operational issues with minimal supervision. Critically analyze data and model process behavior to characterize process performance or troubleshoot root cause. Clearly communicate recommendations to GMP biopharmaceutical customers.
· Assist and train clients with resin column packing.
· Serve as key interface with Sales, R&D, and Marketing teams to communicate Voice of the Customer and Market Trends.
· Travel requirement up to 30%
Minimum Qualifications:
· Bachelor's of Science in Chemical Engineering or Biotechnology with 10+ year's related experience OR Master's of Science in Chemical Engineering with 8+ year's related experience OR PhD in Chemical Engineering or Biotechnology with 5-7+ years' experience.
· 5-7+ years practical experience with downstream biologics purification in a manufacturing or process development environment, including a knowledge of scale-up, process transfer, and cGMP manufacturing.
Preferred Qualifications:
· In depth experience with chromatography operations at pilot or manufacturing scale, including column packing, process validation, and troubleshooting operational issues.
· An understanding of bioprocess economics, as well as strong knowledge of scale-up and scale-down sizing principles.
· A sound knowledge of process engineering fundamentals, especially fluid dynamics.
· Ability to communicate technical concepts to colleagues and clients using excellent written and verbal communication skills.
· Dependable, self-motivated, and able to thrive in an autonomous working environment.
Pay Range: $85,300- $187,700
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
$85.3k-187.7k yearly 32d ago
Engineer II, Validation
Moderna 4.8
Remote or Norwood, MA job
The Role In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. This role will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and equipment remain in an operational state of compliance.
Here's What You'll Do
Perform commissioning, qualification, and validation activities for Moderna's GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities.
Working with external validation service providers. Responsibilities and ensure commitment to key stakeholders are met.
Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards.
Support new equipment qualification activities for capital and operational projects.
Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in-process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.).
Support internal and external audits/inspections as a part of Commissioning, Qualification and Validation program.
Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
Drive results by owning and completing validation initiatives / projects against identified timelines.
Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities.
Additional duties as may be assigned from time to time
Here's What You'll Need (Basic Qualifications)
B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering Etc.). Master's degree in above discipline preferred.
Minimum of 2+ years in commissioning / qualification / validation /quality experience in cGMP manufacturing environments
Here's What You'll Bring to the Table (Preferred Qualifications)
Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE).
Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.
Must be able use his / her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems.
Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.
Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager.
Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The salary range for this role is $72,500.00 - $116,000.00. 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-NB1
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$72.5k-116k yearly Auto-Apply 60d+ ago
Community Impact Liaison
Merck 4.6
Boston, MA job
**Purpose of the Role:** Our Company has created the role of Community Impact Liaisons (CIL) to deepen its commitment to improving health outcomes in key U.S. communities. These roles will focus on strategic social investments that strengthen community-based health systems and address barriers to care-distinct from medical, policy, commercial or brand efforts. Specifically, this role will augment the community engagements our Company is already pursuing by investing in opportunities, including multi-year, that drive community improvements, bolstering the types of support provided to communities, including navigating care and increasing our presence at community-led events.
**Key Responsibilities of CILs:**
Reporting to the Director of Global Community Impact, this role will support grantmaking and collaborative partnerships at the local level in key communities who have been underserved (e.g. Appalachia). The candidate will work with internal and external partners to identify patient barriers and make social investments in community-based solutions.
**The Community Impact Liaison role will be a member of the Global Impact Investing and Giving (GIIG) function within SIS, which:**
+ Identifies high-impact social investments that support community partners working to improve health knowledge, pilot new models of care, strengthen the community health workforce, and build the capacity of health organizations and systems
+ Takes a whole-person health approach, recognizing the full range of social and environmental factors that impact health and well-being
+ Holds deep knowledge and broad networks in our Company's core therapeutic areas, with an emphasis on HIV and including oncology and cardiovascular diseases
+ Emphasizes a community-first approach, designing grantmaking strategies to ensure our work has impact on access to health that is responsive to community needs
**The candidate will be responsible for:**
+ **External Engagement:** Collaborate with Community-Based Organizations (CBOs), Non-Governmental Organizations (NGOs), and foundations to improve key health system strengthening outcomes for vulnerable groups.
+ **Local Presence:** Live and work in priority regions to build trust and relevance.
+ **Strategic Social Investment:** Identify opportunities and provide catalytic funding to initiatives like patient navigation and specialty care access programs.
+ **Convening Power:** Organize local events to foster collaboration among community stakeholders.
+ **Portfolio Oversight and Impact Monitoring and Measurement:** Monitor and interpret community health data as well asmanage, evaluate, and report on outputs and outcomes of a diverse set of community-based health initiatives that drive Access to Health goals.
+ **Cross-Functional Alignment:** Ensure efforts complement (not duplicate) work by Patient Innovation & Engagement (PI&E - our Research & Development division), and policy teams (HH and Corporate Affairs).
**Distinctive Features**
+ **Non-commercial:** Fully separated from our Company's commercial and brand activities.
+ **Catalytic Funding:** Designed to unlock sustainable, scalable community health solutions.
+ **Collaborative Leadership:** Work closely with internal leaders and external partners to drive impact.
**QUALIFICATIONS**
**Education:**
+ **Required** - BA/BS in Business, Marketing, Life Sciences, Public Health, Policy or related field
+ **Preferred** - Graduate degree in Public Health, Health Policy, or Allied Health fields
**Experience:**
+ 5+ years' experience working in community leadership or engagement role in health care systems or life sciences.
+ Experience collaborating with non-profit community-based organizations as well as city, county, or state health departments in identifying critical needs, aligning on shared goals, and negotiating mutual outcomes.
+ Experience in design and award of effective community grants - including identification of objectives and desired outcomes, development of Requests for Proposals, assessment of responses, Legal and Compliance reviews, contracting and reporting.
**Skills:**
+ Strong competency in independently translating community input and qualitative findings into impactful program designs
+ Capacity to synthesize community health epidemiology and social risk factors into practical recommendations for relevant evidence-based program strategies
+ Expertise in monitoring and interpreting community health data, including surveillance trends, and social determinants of health, to identify priority needs and emerging issues
+ Ability to work in a complex environment while driving systemic change through consensus-building, managing conflict, a deep understanding of the local context, and building trust with key stakeholders.
+ Analytical ability, business acumen, decision-making ability, and problem-solving skills
**Reporting to:** Director of Global Community Impact, Global Impact Investing and Giving, Social Impact and Sustainability
**Supervisory Responsibilities:** No
**Effort:** Full-time
**Required Skills:**
Building Consensus, Building Consensus, Business Acumen, Charitable Organizations, Collaborative Leadership, Communication, Communication Strategy Development, Community Connections, Community Health, Continuous Quality Improvement (CQI), Environmental Social And Governance (ESG), ESG Analysis, Fundraising Management, Health Sciences, Impact Investing, Inventory Management, Life Science, Marketing, Media Communications, NGO Management, Policy Development, Program Implementation, Public Health, Public Health Research, Request for Proposals (RFP) Development {+ 5 more}
**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
$126,500.00 - $199,100.00
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:**
Remote
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Job Posting End Date:**
01/13/2026
***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:** R378412
$51k-64k yearly est. 5d ago
Manager, HCP Engagement Operations - Sponsorships & Joint Working
Regeneron Pharmaceuticals 4.9
Uxbridge, MA job
Regeneron is looking for a manager to join our HCP Engagement Operations team, specializing in Sponsorships & Joint Working. In this role, you will coordinate operational management of sponsorships and joint working activities across international markets, ensuring alignment with company policies, regulatory requirements, and industry standards. Your work will contribute to operational excellence, compliance, and continuous process improvement, making a meaningful impact on healthcare community partnerships.
If you're ready to collaborate globally, manage vendors effectively, and drive operational success, we invite you to apply and be part of our dynamic team.
A typical day may include:
* Responsibility of sponsorship and joint working requests, approvals, and contract execution to ensure compliance with company policies and regulatory standards.
* Managing and updating contract templates, coordinating amendments, and collaborating closely with legal teams for third-party contracts.
* Coordinating sponsorship activities involving healthcare professionals, ensuring timely execution and adherence to local regulations.
* Collaborating with external vendors to supervise performance and track agreed SLAs and critical metrics.
* Forecasting and supervising budgets to support operational efficiency.
* Serving as a point of contact for internal collaborators regarding sponsorship and joint working inquiries.
* Ensuring accurate documentation and audit readiness across all processes.
* Supporting the development of standardized processes, templates, and tools to streamline operations.
* Partnering with cross-functional teams to analyze program effectiveness and identify optimization opportunities.
This role may be for you if you:
* Have experience managing contracts, templates, and external vendor relationships in an operational setting.
* Are skilled in budget management, reporting, and workflow optimization within a regulated environment.
* Are proficient in CRM or event management systems and comfortable with data tracking and analytics.
* Excel at collaborating in a matrixed organization and managing partners across geographies and cultures.
* Have a solid understanding of pharmaceutical sponsorship processes and regulatory requirements.
* Possess strong organizational skills, attention to detail, and proactive problem-solving abilities.
* Thrive in fast-paced environments and can prioritise effectively.
* Are passionate about driving operational excellence and maintaining compliance.
To be considered:
You must have a Bachelor's degree in Business, Life Sciences, or a related field, along with 3-5 years of experience in HCP engagement operations, sponsorship management, or commercial/medical affairs support within the pharmaceutical, biotech, or life sciences industry.
Preferred qualifications include experience with CRM systems, event management platforms, and a strong familiarity with industry codes like EFPIA and ABPI, as well as GDPR compliance.
Join us in making a difference in healthcare through transparent, compliant, and impactful sponsorship operations. Apply today!
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.
$114k-149k yearly est. Auto-Apply 2d ago
Associate Director, Biostatistics - Hematology
Regeneron Pharmaceuticals 4.9
Uxbridge, MA job
This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. In this role, a typical day might include: The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will represent statistical issues in regulatory agency meetings. The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications. As an Associate Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage full-time staff.
This role might be for you if can:
* Represent Biostatistics at Global Clinical sub-teams.
* Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
* Lead contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.
* Lead and contributes to process improvement and technical working groups and sets timelines and expectations for the deliverables. Authors new/revised SOPs and contributes to cross-functional EPIC workstreams.
* Evaluate appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
* Prepare presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management.
* Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.
To be considered for this opportunity, you must have the following:
* PhD or equivalent degree in statistics/biostatistics with >6 years of experience in the pharmaceutical industry OR MS degree in statistics/biostatistics with >11 years of experience
* Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience or similar Therapeutic Area.
* Time to Event (TTE) experience.
* Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
* Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment.
* Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.
* Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
* Expertise in statistical software
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.
Salary Range (annually)
$173,500.00 - $283,100.00
$173.5k-283.1k yearly Auto-Apply 2d ago
Senior Review Committee Specialist
Regeneron Pharmaceuticals 4.9
Uxbridge, MA job
At Regeneron, we are dedicated to transforming lives through science and innovation. We believe in fostering a culture of collaboration, excellence, and continuous development. We strive to make a substantial impact on patients' lives by delivering innovative treatments and solutions. We are seeking a dedicated and detail-oriented Senior Specialist to join our International Commercial Operations team. In this pivotal role, you will oversee the day-to-day operations of the Review Committee Team, ensuring the flawless Medical, Legal, and Regulatory (MLR) review of promotional materials for all Regeneron products and therapeutic areas across Europe, Canada and Japan. Your work will uphold the highest standards of quality, integrity, and compliance with legal and regulatory requirements. This is an exciting opportunity to contribute to the evolution of content operations and make a meaningful impact on a global scale.
A Typical Day:
* Facilitate and manage Review Committee meetings to ensure compliance with policies, accurate outcomes, and timely incorporation of revisions.
* Guide promotional material sponsors on review timelines and provide proactive submission guidance.
* Collaborate with country marketing and medical teams to capture and implement business requirements on Veeva PromoMats. Staying updated on Veeva PromoMats features and incorporate them to streamline content review and approval.
* Support the evolution of content operations from traditional approval processes to modular content creation and approval.
* Actively participate in quality assurance checks and audits to ensure operational excellence.
* Manage vendor communications, system updates, and improvements for content approval platforms.
This Role May Be For You If:
* You thrive in a collaborative environment and enjoy building positive relationships with diverse stakeholders.
* You are passionate about operational excellence, ensuring timely and accurate project deliverables.
* You have a proactive mindset, staying ahead of industry trends and incorporating innovative tools and processes.
* You take pride in your communication skills and can effectively convey sophisticated ideas to various audiences.
* You enjoy working with technology and are proficient in enterprise content management platforms like Veeva PromoMats and Aprimo.
To Be Considered:
We are looking for candidates with at least 5 years of professional experience, preferably in the healthcare or pharmaceutical industry, and a minimum of 3 years in commercial content review and approval operations. A bachelor's degree is required (or equivalent experience), along with proficiency in MS Office tools and content management platforms like Veeva PromoMats & Aprimo. Multilingual skills (e.g., Spanish, German, French, Italian, Japanese) are preferred but not mandatory. Applicants should also demonstrate strong project management abilities and a high level of attention to detail.
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.
$94k-117k yearly est. Auto-Apply 2d ago
Research Associate/Engineer I, Technical Development (2026 Rotation Program)
Moderna 4.8
Norwood, MA job
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.
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$63.2k-100.9k yearly Auto-Apply 60d+ ago
Director CMC Regulatory Affairs
Regeneron Pharmaceuticals 4.9
Uxbridge, MA job
Leads the Chemistry, Manufacturing, and Controls (CMC) & Combination Products (CP) Internal Medicine team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams and development partners, and leading activities with the Health Authority.
A typical day might include:
Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction for the assigned portfolio, including initial clinical registrations, market application approvals, and post-approval lifecycle management.
Lead the preparation, review, and submission of regulatory documents (e.g., meeting packages/briefing book, scientific advice, BLAs, MAAs, BPDRs, supplements) to regulatory authorities.
Provide scientific and regulatory inputs for the assigned portfolio to facilitate and expedite the development and marketing of drugs and/or biologics.
Oversee and direct interactions with global regulatory authorities, including meetings, information request responses, and inspections.
Direct and provide advice on the compliance activities (e.g., change controls, deviations) for the assigned portfolio, evaluating regulatory impacts and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific guidelines.
Develop and implement department objectives and work plans, delegate responsibility effectively, and prioritize team workloads to meet organizational goals.
Provide leadership by contributing to departmental strategy, organizational goals, and policy development.
Guide team members to address complex and unprecedented program challenges, ensuring timely resolution.
Participate in cross-functional groups and working groups to improve current practices and establish new processes/procedures
This Role Could Be a Great Fit If You Have:
Proven track record of supporting biological products and/or small molecule drugs through development and approval is a distinct advantage.
Strong understanding of current CMC / CP worldwide regulations.
Successful leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for biological products, combination products, and/or small molecule drugs.
Previous experience with device regulatory requirements and development processes for combination products is an advantage.
Human Factors experience is a plus.
Experience in dealings with the FDA and other regulatory authorities.
Experience managing and developing staff members.
In order to be considered for this role, you must have:
A bachelor's degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including a minimum of 8 years of relevant CMC experience. Alternatively, a master's degree with 8+ years of experience, or a PhD degree with 3+ years of experience.
At least 3 years of applicable managerial experience.
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.
Salary Range (annually)
$172,200.00 - $286,900.00
$172.2k-286.9k yearly Auto-Apply 25d ago
Clinical Imaging Scientific Director (Oncology)
Regeneron Pharmaceuticals 4.9
Boston, MA job
The Clinical Imaging Scientific Director for Oncology will own the strategy and execution of complex early through late-phase oncology imaging in clinical trials where imaging plays a key role. Imaging includes all modalities with a special focus on PET and CT. In this role, you will champion the development of imaging endpoints and biomarkers and drive the scientific imaging aspects as well as tumor response assessment of oncology clinical studies in partnership with clinical sciences and preclinical research teams.
In this role, a typical day might include the following:
* Create fit-for-purpose imaging biomarker strategies and work closely with research, clinical imaging and the oncology therapeutic area for the development of imaging endpoints to inform and advance the Regeneron clinical pipeline.
* Prepare and present clinical imaging strategies to senior management.
* Manage a complex network of stakeholders across Regeneron.
* Lead, design and implement multi-modality imaging measures as endpoints for oncology therapeutic clinical studies.
* Collaborate closely with Regeneron clinical teams as imaging subject matter expert to ensure optimal design and execution of imaging strategy including development of protocols, imaging endpoints, imaging manuals, imaging charters, statistical analysis plans and clinical study reports.
* Work closely with Clinical Imaging Operations and imaging contract research organizations to ensure the flawless conduct and data integrity of studies' imaging components and endpoints.
* Serve as Study Scientific Director for clinical trials focused on qualification and utilization of novel imaging biomarkers.
* Lead the interaction with regulatory agencies for communications regarding imaging endpoints and procedures.
* Lead the interaction with regulatory agencies and site ethic committees for approval of clinical imaging biomarker development studies
This Job Might Be For You If You Have:
* Experience as study scientific director of PET imaging biomarker clinical trials in Oncology.
* Experience applying PET imaging as a quantitative endpoint in clinical and preclinical studies in Oncology.
* People management experience.
* Direct experience with preclinical oncology imaging models using PET and immuno-PET imaging biomarkers.
* Strong background in oncology, biology, molecular imaging, radiopharmceuticals and familiar with precision medicine approaches.
* Imaging CRO oversight and implementation of quality control procedures.
To be considered for this role, you must have a PhD with a minimum of 10+ years of clinical imaging experience (minimum of 7 years within oncology drug development). Experience implementing central efficacy assessments using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano and IMWG in oncology clinical trials is required. We also are looking for you to have had successful engagement experience with regulatory agencies and the ability to champion imaging innovations and lead projects effectively.
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
$109k-154k yearly est. Auto-Apply 2d ago
Specialist, Digital Asset Management
Merck 4.6
Remote or Boston, MA job
The US Human Health Global Headquarters (HH GHQ) Asset Management Specialist's scope spans over three primary areas: + Responsible for approving the taxonomy, metadata and classification of the company's digital assets. + Determining the access and usage for these digital assets in their area of responsibility.
+ Acquiring permission to use specific classes of assets that are copyrighted by publishers.
The successful candidate will join the Global Marketing Operations team and will be responsible for providing document approval in our digital asset management system, Veeva PromoMats. The US/GHQ Asset Management Specialist will become the "go to" person for their assigned brands to work in collaboration with Creative Agencies and Job Owners in managing, storing, sharing, and re‑using content and assets in our promotional materials. In addition, a key responsibility is to ensure compliance of copyright agreements with their relevant assets stored in PromoMats. May collaborate with our company's copyright attorneys to resolve copyright concerns.
**Qualifications:**
+ **Education Minimum Requirement:** Bachelor's degree in library, Business and/or Information Science, or 3 years comparable experience in relevant/related field, is required.
+ Candidate must be available to work in the US time zones (EST preferred)
**Required Experience and Skills:**
+ A background in or similar to library science and/or experience with digital asset management, as well as experience with copyright management, is highly desired
+ Knowledge of media usage rights and licensing
+ Proficiency in English language required (written and spoken)
+ Experience working with print and/or multichannel production files
+ Ability to operate independently while managing multiple projects
+ Ability to communicate effectively with, train, and present to multiple stakeholders, including internal marketing teams and external agencies
+ Excellent verbal and written communication
+ Ability to learn new skills quickly
+ Ability to work collaboratively and efficiently within cross‑functional teams
+ Highly detail oriented, exceptional organizational skills, thrive when multitasking, and be able to consistently meet tight deadlines in a timely manner
**Preferred Experience and Skills:**
+ Experience with digital asset management systems
+ Familiarity with Veeva PromoMats
+ Knowledge of the pharmaceutical industry; in particular, familiarity with promotional material review process for the pharmaceutical industry is desired
**Required Skills:**
Communication, Communication, Communications Programs, Content Creation, Copyright Compliance, Customer Journey Mapping, Customer Relationship Management (CRM) Utilization, Data Analysis, Design Thinking, Detail-Oriented, Digital Asset Management (DAM), Digital Assets, Digital Marketing, Enterprise Digital Asset Management, Event Planning, Library Science, Marketing, Marketing Campaign Development, Market Research, Media Relations, Multi-Management, Multitasking, Music Licensing, Oral Communications, Pharmaceutical Management {+ 5 more}
**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
$77,700.00 - $122,300.00
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:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
01/20/2026
***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:** R373619
$77.7k-122.3k yearly 5d ago
Sr Manager, Marketing (Hematology)
Regeneron Pharmaceuticals 4.9
Uxbridge, MA job
At Regeneron, we are dedicated to transforming lives through science and innovation. We are seeking a dynamic and entrepreneurial Haematology Commercial Leader to join our team in the UK & Ireland. This hybrid role blends sales and marketing expertise, offering you the opportunity to build the commercial success of our Haematology portfolio while adapting global strategies to meet local market needs. If you're passionate about driving impactful results and thrive in a collaborative environment, this role is for you.
In this position, you'll play a pivotal role in adapting and implementing global brand plans, ensuring flawless cooperation across cross-functional teams, and championing Regeneron's values in everything you do. This position offers growth opportunities as the portfolio expands, making it an exciting time to join Regeneron.
A Typical Day:
* Develop and implement brand plans for the Haematology portfolio, aligning efforts and budgets with growth objectives and global strategy.
* Adapt and gain approval for UK-specific materials derived from global resources, ensuring minimal changes while maintaining compliance.
* Own the development of launch strategies, account planning, and commercial advisory boards to optimize market understanding and opportunities.
* Build and implement National, Regional, and Local account plans with clear prioritisation and trade-offs to achieve commercial success.
* Expand Regeneron's reputation and relationships with key healthcare professionals across therapy areas.
* Collaborate with cross-functional colleagues to analyse market dynamics and trends, supporting brand and collaboration objectives.
* Maintain the highest ethical and compliance standards while encouraging positive relationships with internal and external stakeholders.
This Role May Be For You If:
* Are a self-starter with an ambitious mindset, capable of blending local strategy with global objectives while keeping things simple and actionable.
* Thrive in a hybrid role that demands adaptability, prioritisation, and a hands-on approach to ensure commercial success.
* Excel at building relationships and credibility with KOLs partners.
* Possess excellent planning, communication, and presentation skills, and are comfortable navigating CRM systems and sales data.
* Are willing to travel 30-40% of the time, including occasional weekends for conferences and meetings.
* Have a passion for maintaining ethical standards and aligning with our values.
To Be Considered:
The ideal candidate will hold a BS/BA degree (Master's degree or advanced certifications preferred) and have over 10 years of biopharma experience, including proven success as a sales manager and marketer. Strong leadership and communication skills are crucial, along with proficiency in English (a second European language is advantageous). Experience in immunology or biologics and established relationships with oncology KOLs are highly desirable.
Join us in making a meaningful impact in Haematology while advancing your career in a role that blends strategy, execution, and collaboration.
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.
$118k-146k yearly est. Auto-Apply 55d ago
Senior Manager, Global Development- AI Engineer
Regeneron Pharmaceuticals 4.9
Uxbridge, MA job
Global Development (GD) is embarking on a digital transformation project that will incorporate AI, machine learning, and automation into our processes to help us reduce cycle times, improve quality, and allow us to focus on more meaningful work. This position will play a key role in developing the platforms, processes and technologies that will incorporate AI effectively across GD. The AI engineer will work with a team of engineers and scientists to help bring transformative change to GD. The role will encompass a wide range of AI/ML-related activities, from data engineering and technical development to optimizing vendor systems for use at Regeneron to mentoring colleagues in best practices for adopting and AI in their everyday workflows. Development will not necessarily be limited to the use of generative AI, but may also include technical implementation of machine learning models, natural language processing, and other approaches. The engineer will work with stakeholders across GD and Regeneron (e.g. enterprise IT, commercial, research, etc.) to develop solutions and architectures that not only address GD's needs but also integrate into the overall corporate strategy.
As a Senior Manager, a typical day may include:
* Implement, and refine novel algorithms and scalable AI /ML solutions tailored to GD applications such as clinical trial design, regulatory intelligence, patient identification and stratification, etc. Deploy these solutions to production environments as appropriate Implementation includes hands-on development and coding.
* Develop, implement, and improve data architecture and engineering approaches for diverse data sources across GD
* Contribute to initiatives with GDIT and enterprise IT to build the necessary infrastructure (software and hardware) to support advanced analytics
* Collaborate with GD colleagues to help them approach AI/ML more effectively
* Establish rigorous validation frameworks for AI models and monitor existing models for accuracy and efficiency
* Stay up to date with the latest advances in the field and, as appropriate, evaluate them for adoption at Regeneron
To be considered for this opportunity, you must have the following:
* Deep understanding of generative AI, machine learning, natural language processing, and statistical modeling
* Deep expertise in programming (Python, R, etc.), with a focus on applying advanced technical skills to data analysis, pipeline creation, automation, and software development
* Expertise in database platforms and cloud computing infrastructure
* Track record of model development, implementation to scale, maintenance, and evaluation in a healthcare of life sciences setting
* Experience managing and analyzing large-scale clinical datasets
* Excellent communication skills, both technical and non-technical
* Experience managing multiple projects
* Experience working in cross-functional teams
* May require travel up to 20%
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.
Salary Range (annually)
$148,300.00 - $241,900.00
$148.3k-241.9k yearly Auto-Apply 2d ago
Laboratory Equipment IT Engineer, Regeneron Cell Medicines
Regeneron Pharmaceuticals 4.9
Cambridge, MA job
We are seeking a motivated **Laboratory Equipment IT Engineer** to support and maintain Building Management, Clinical Manufacturing Equipment and data acquisition/monitoring systems that support Clinical Manufacturing and Research and Development (R&D). This role is a part of Regeneron Cell Medicines (RCM), a newly formed R&D unit within Regeneron to advance cell therapies and combination approaches in oncology and immunology. We hope you are excited to serve as the technical SME as well as operate at the system administration, engineering, and management levels.
**As an Laboratory Equipment IT Engineer, a typical day might include the following:**
+ Supporting all manufacturing and QC equipment within RCM's 30,000 SF Phase 1 clinical manufacturing facility
+ Maintaining System documentation, including converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans, and summary reports
+ Leading IT Applications systems security access and periodic audit trail reviews
+ Performing investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software
+ Support engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, and testing to meet end user requirements
+ Supporting automation activities by updating/authoring system specifications, user and functional requirements specifications, as well as generating and implementing necessary FAT and SAT protocols
+ Designing and developing test plans and implementing software/hardware improvements to automated process control and process monitoring equipment according to change control procedures
+ Ensuring systems' data is backed up / archived as required to ensure system can meet defined RTO and RPO; perform recovery of data as needed
+ Creating and maintaining configuration specifications for cGMP software for process control, monitoring and testing
+ Ensuring systems remain in compliant state including process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments
+ Supporting system integration with existing systems (ex. LIMS, Historian) as required by business needs
**This role might be for you if you:**
+ You enjoy working in a fast-paced environment and can be flexible with changing priorities
+ You thrive in a team-based, multi-functional, collaborative environment
+ You possess a problem-solving mentality
+ You have excellent verbal and written communication skills
**In order to be considered for this role,** you must have at least a Bachelor's degree in Information Technology or related field and 3-5 years of relevant experience in a manufacturing/lab/IT setting. Must have experience in a pharmaceutical or biopharmaceutical manufacturing facility. Must have experience with automated systems for environmental monitoring and compliance; Rees is preferred. Experience working in a GMP environment is very advantageous.
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)**
$79,100.00 - $129,100.00
$79.1k-129.1k yearly 60d+ ago
Associate Principal Scientist, Clinical Research
Merck 4.6
Remote or Boston, MA job
The 2-year Physician Scientist Program provides pharmaceutical medicine training and opportunities to physicians completing residency or fellowship with the goal of recruiting new talent and contributing to the organization's inclusion objectives. The program provides in-depth exposure to clinical drug development with emphasis on key elements of clinical trial planning, execution, data analysis and reporting of clinical trial results. Physician Scientists will develop skills working with clinical and cross-functional teams as clinical programs progress toward regulatory approvals.
Successful candidates will spend their first year in one of the following areas: (a) **Global Clinical Development:** Understand the role and methods of pharmaceutical research, participate in the writing of research protocols, conduct of clinical trials, safety monitoring, analysis of data and communication of study findings; (b) **Global Regulatory Affairs and Clinical Safety:** Focus on late-stage and lifecycle drug activities, understand key regulatory policies and the procedures for interacting with health agencies (e.g. FDA); understand key elements in pharmacovigilance, drug safety monitoring, signal detection and processing of adverse reports; (c) **Global Medical/Scientific Affairs:** Exposure to the management of a product asset prior to, during and after the launch phase (US and Global) including caveats on drug promotion. After a successful first year, the Physician Scientist will be equipped to assume a leading role in the team with additional responsibilities and interactions. The Physician Scientist also has the opportunity to do a second 1-year rotation in another area instead.
**Required Education and Experience: **
+ Candidates must currently hold an MD degree and have completed residency or fellowship training in an accredited US medical program, preferably within the last 5 years.
**Required Skills:**
Clinical Development, Clinical Research, Clinical Sciences, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Communication, Drug Development, Drug Research, Ethical Standards, Good Clinical Practice (GCP), Medical Research, Medical Writing, Pharmaceutical Research, Pharmacy Regulation, Protocol Development, Regulatory Policies, Research Proposals, Scientific Consulting, Scientific Research
**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
$190,800.00 - $300,300.00
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
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**Job Posting End Date:**
01/30/2026
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**Requisition ID:** R380993
$94k-125k yearly est. 3d ago
Senior Manager Clinical Study Lead (Oncology)
Regeneron Pharmaceuticals 4.9
Uxbridge, MA job
The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives.
This role is not eligible fully remote. This role is required to be onsite in one of our locations.
A typical day in this role looks like:
* Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
* Provides operational input into protocol development
* Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
* Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
* Ensures compliance with the clinical trial registry requirements
* Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
* Provides input into baseline budget development and management
* Provides input into baseline timeline development and management
* Leads risk assessment and identifies risk mitigation strategies at the study level
* Leads the feasibility assessment to select relevant regions and countries for the study
* Oversees/conducts site evaluation and selection
* Leads investigator meeting preparation and execution
* Monitors progress for site activation and monitoring visits and acts on any deviations from plan
* Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
* Monitors data entry and query resolution and acts on any deviations from agreed metrics
* Ensures accurate budget management and scope changes for internal and external studies
* Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
* Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
* Oversees the execution of the clinical study against planned timelines, deliverables and budget
* Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
* Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
* Ensure clinical project audit and inspection readiness through the study lifecycle
* Supports internal audit and external inspection activities and contributes to CAPAs as required
* Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
* Contributes to clinical study report writing and review
* Facilitates and contributes to study level lessons learned
* Assigns tasks to Clinical Study Management staff and supports their deliverables
* Recommends and participates in cross-functional and departmental process improvement initiatives
* Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
* May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
* Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
* May require 25% travel
This role may be for you if you have:
* Exceptional interpersonal & leadership skills
* Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
* Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving
* Advanced communication skills via verbal, written and presentation abilities
* Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
* Ability to influence and negotiate across a wide range of stakeholders
* Strong budget management experience
* An awareness of relevant industry trends
* Ability to build, lead and develop productive study teams and collaborations
* Applies advanced negotiation and interpersonal skills to vendor management
* Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
* Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
* Knowledge of ICH/GCP and regulatory guidelines/directives
* Advanced project management skills, cross-functional team leadership and organizational skills
* Line management experience
In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience.
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.
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