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Moderna jobs in Cambridge, MA

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  • Payroll Manager, U.S. & Canada

    Moderna 4.8company rating

    Moderna job in Cambridge, MA

    The Role Moderna is seeking a highly skilled and motivated Payroll Manager to lead and strategically manage payroll operations for our U.S. and Canada entities. This role oversees all aspects of U.S. (multi-entity, multi-state) and Canadian (multi-entity) payroll operations, including coordination of related equity transactions. The Payroll Manager will serve as a trusted payroll expert, driving operational excellence, compliance, and continuous improvement across all payroll activities. They will lead a team responsible for end-to-end payroll operations across multiple entities and jurisdictions, ensuring timely, accurate, and compliant payroll delivery. The ideal candidate will bring advanced proficiency in Workday Payroll and ADP SmartCompliance, and a proven track record of delivering accurate and compliant results. Success in this role requires strong attention to detail, integrity in managing sensitive data, and a commitment to process optimization, compliance, and data accuracy. As a key partner to HR, Finance, Digital, Legal, and external vendors, this individual will champion payroll accuracy, innovation, and collaboration in support of Moderna's fast paced and evolving business. This role will also lead high-impact initiatives to enhance system automation, strengthen internal controls, and scale payroll operations in alignment with Moderna's mission to deliver on the promise of mRNA science. Here's What You'll Do Lead end-to-end payroll operations for U.S. (multi-entity, multi-state) and Canadian (multi-entity, multi-province) payrolls, ensuring timely, accurate processing, compliance with all laws and internal policies, and precise reporting. Utilize ADP SmartCompliance expertise to manage wage and tax compliance and administration across the U.S. and Canada. Oversee quarterly and year-end payroll activities, including reconciliations, tax filings, and audit support (e.g., W-2s, T4s, RL-1s, ROEs), ensuring accuracy and compliance across jurisdictions. Serve as the payroll subject matter expert, advising HR, Finance, Digital, and Legal partners on best practices, systems, and compliance. Develop and execute payroll strategies that align with Moderna's business goals, supporting scalability, compliance, and operational efficiency across North America. Provide payroll insights and analytics to HR and Finance leadership to inform decision-making, forecasting, and budgeting. Partner cross-functionally with HR, Finance, Digital to align payroll processes, support audits, and ensure seamless employee pay experience. Collaborate with Total Rewards and Global Mobility teams on equity processing, expatriate shadow payroll, cross-border reporting, and payroll-impacting events such as transfers, relocations, and repatriation. Manage and mentor the payroll team, fostering a culture of collaboration, accountability, and continuous improvement. Champion process improvement initiatives, leveraging employee feedback and audit insights to enhance the payroll experience and strengthen controls. Ensure compliance by monitoring and interpreting U.S. federal, state, and local, as well as Canadian federal and provincial, tax and labor regulations; proactively advise on changes to mitigate risk. Oversee withholding tax compliance and risk management for U.S. and Canadian entities in collaboration with Legal and Finance. Manage payroll for equity and bonus transactions, ensuring accurate taxation and reporting in partnership with Total Rewards. Lead vendor management, including payroll providers and tax partners, ensuring service quality and adherence to SLAs. Partner with Digital to optimize Workday Payroll configurations and integrations with timekeeping, benefits, and finance systems. Identify and implement automation opportunities to improve payroll accuracy, efficiency, and scalability. Maintain SOX compliance and internal controls, ensuring proper documentation and audit readiness. Deliver exceptional employee support, escalate and resolve payroll inquiries promptly and accurately while maintaining confidentiality and professionalism. Collaborate with Employee Experience and HR Communications to keep payroll policies, FAQs, and resources current and accessible. Work closely with Global Payroll counterparts to share best practices, enhance data governance, and drive global consistency. Here's What You'll Need (Basic Qualifications) Bachelor's degree in Accounting, Finance, Business Administration, or a related field, or equivalent work experience. 7+ years of progressive payroll experience, including payroll management for U.S. and Canada in a complex, multi-entity, fast-paced organization. Strong knowledge of payroll regulations, wage and hour laws, and tax compliance across U.S. federal, state, and local, as well as Canadian federal and provincial jurisdictions. Hands-on experience with Workday Payroll and integrated HR, benefits, and financial systems. Experience managing vendor relationships, including payroll providers and tax partners. Proficiency in ADP SmartCompliance for wage and tax compliance administration. Demonstrated ability to manage quarterly and year-end payroll activities, including reconciliations, filings, and audits. Strong analytical, organizational, and problem-solving skills with high attention to detail and accuracy. Proven ability to handle confidential information with integrity and discretion. Excellent communication and collaboration skills, with experience partnering cross-functionally across HR, Finance, Digital, and Legal. Here's What You'll Bring to the Table (Preferred Qualifications) Certified Payroll Professional (CPP) preferred. 7+ years of payroll leadership experience, with responsibility for multi-entity, multi-jurisdictional operations across the U.S. and Canada. Advanced Workday Payroll expertise, including configuration, integration, and report development. Experience managing equity and incentive payrolls, including taxation and reporting. Strong proficiency in Microsoft Excel and data analytics tools. Proven ability to develop payroll strategies and implement process improvements that enhance accuracy, efficiency, and scalability. Experience with SOX compliance, internal controls, and audit readiness. Background supporting international assignments and global mobility programs. Demonstrated leadership in team development and mentoring, fostering a culture of accountability and continuous improvement. Passion for Moderna's mission, thriving in a high-growth, innovative, and fast-paced environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. #LI-CK1 -
    $109.2k-174.6k yearly Auto-Apply 29d ago
  • Research Associate/Engineer I, Technical Development (2026 Rotation Program)

    Moderna 4.8company rating

    Moderna job in Norwood, MA

    The Role is located in Norwood, MA and has a start date of August 3, 2026. The Technical Development organization at Moderna is looking for top talent in science and engineering to deliver on its mission to design manufacturing processes for mRNA medicines. This posting is for a full-time position in Moderna's Technical Development Rotation Program. Rotation Program participants will have an exciting opportunity to explore different areas of mRNA therapeutic development through completing three 6-month rotations in Technical Development. Participants will be part of high-performing project teams developing new manufacturing platforms to produce mRNA therapeutics and vaccines destined for clinical trials and commercial licensure. You will apply your educational background and learn new technical skills in the synthesis of mRNA, assembly of lipid nanoparticles, and formulation of drug products. Through completing an operational rotation, you will develop a deep understanding of how Technical Development's efforts enable the manufacture of mRNA medicines. Technical Development is based in Norwood, MA. Here's What You'll Do Work with a team of highly skilled experts to come up to speed on technology and techniques. Use laboratory, technical and communication skills to generate experimental results, perform data analysis, and document in formal reports including conclusions and recommended next steps. Perform process scale-up, support technology transfer and provide manufacturing support at internal Moderna, and external contract manufacturing sites. Participate in planning, design, execution, analysis of experiments and formal risk assessments to establish critical process parameters, and overall process control strategies. Optimize the impact of formulation and processing conditions on the stability of mRNA drug products and process intermediates. Review and share relevant academic literature and establish new collaborations with internal research and manufacturing groups. Create scaled-down models, and high throughput experimental setups for unit operations. Characterize mRNA and lipid nanoparticles through collaboration with the analytical team. Prepare technical reports and present finding in cross-functional meetings. Additional duties as may be assigned from time to time. Here's What You'll Need (Basic Qualifications) Bachelors or Masters Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biomolecular Engineering, Chemistry, Biochemistry, Biomedical Engineering, Biophysics, Biostatistics, Biotechnology, Mathematics, Molecular Biology, Pharmaceutical Science, Statistics, or a related field preferred. Strong fundamental scientific and engineering skills for the evaluation of experimental data Laboratory skills applicable to bioprocess development and analytical methods At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work. Here's What You'll Bring to the Table (Preferred Qualifications) GPA of 3.5 on a 4 scale or equivalent Demonstrated ability to work both independently as well as the ability to contribute to high performing teams. Excellent written and verbal communication skills. Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations (GxP, GMP, GLP) A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $63,200.00 - $100,900.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. -
    $63.2k-100.9k yearly Auto-Apply 41d ago
  • Director CMC Regulatory Affairs

    Regeneron Pharmaceuticals 4.9company rating

    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 23d ago
  • Head of Nonclinical Safety Evaluation

    Moderna 4.8company rating

    Moderna job in Cambridge, MA

    The Role At Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic, diverse, and innovative workplace where every individual's contribution is vital. We are seeking a seasoned scientific leader to serve as the Head of Nonclinical Safety Evaluation, overseeing both Toxicology and Pathology functions. This role will be instrumental in driving nonclinical safety strategies across Moderna's mRNA pipeline and platform technologies, leading a multidisciplinary team to ensure scientific rigor, regulatory compliance, and an integrated risk assessment for programs from discovery through clinical development. The experienced incumbent will fulfill a key leadership role within our organization, responsible for building team capabilities, overseeing and advancing the Toxicology and Pathology functions and collaborating with leaders from other departments across the Moderna ecosystem to deliver life-changing medicines and vaccines to patients. The incumbent will play a critical role as an enterprise leader, proactively planning for and executing on an organizational design and team structure that enables the team to flexibly support programs across a diverse early- and late-stage pipeline. A track record of superior communication skills, innovative problem-solving skills that navigate complex challenges, and comfort working in a dynamic, fast-paced, cross-functional team environment are required. Here's What You'll Do In alignment with the corporate mindsets, lead and develop a high-performing team of toxicologists and pathologists, cultivating a culture of innovation, collaboration, and excellence. Provide integrated strategic direction for the Toxicology and Pathology functions to support nonclinical safety evaluation for all stages of drug development. Apply in-depth knowledge of how nonclinical safety disciplines (including but not limited to general toxicology, safety pharmacology, genotoxicity, developmental and reproductive toxicology, and carcinogenicity) integrate with other areas across the business and utilize business/market expertise to differentiate Moderna from the competition. Evaluate nonclinical safety challenges in a complex or fast-changing environment and direct the development of new or innovative solutions with in-depth analysis and interpretive thinking. Lead and manage a team of toxicologists and pathologists (including but not limited to clinical pathology and/or anatomic pathology subject matter experts) across a range of job levels and experience (may include people leaders), fostering a culture of innovation, collaboration, functional excellence, and continuous learning and development within the team, supporting career growth and professional development opportunities for team members. In conjunction with platform and pipeline program teams and a cross-functional and integrated Nonclinical Drug Development Sciences team, provide strategic oversight on and coach/guide team members on the development of scientifically-sound nonclinical safety strategies to provide expert support to discovery and development projects. Accountable for the design, execution, and critical analysis of nonclinical safety in vitro and/or in vivo studies conducted in multiple species under the nonclinical safety assessment umbrella via collaborative partnerships with study monitors and other partner line program representatives (e.g., DMPK, bioanalytical, operations, etc.). Accountable for toxicology assessments supporting extractable/leachable and contaminant risk assessments and/or impurity qualification. Collaborate cross-functionally with research, clinical, DMPK, bioanalytical, operations, clinical development, clinical safety, and regulatory colleagues to ensure holistic safety assessments. Serve as a key voice in regulatory agency interactions, internal governance and/or leadership meetings when nonclinical data package conclusions and impact of study results on program and clinical/regulatory strategy are presented. Apply expert scientific and regulatory writing experience when critically reviewing, editing, and authoring submission application documents (INDs, CTAs, BLAs and MAAs) and health authority interaction documents (e.g., briefing documents, regulatory query responses) and integrate results with DMPK and pharmacology. Ensure alignment of toxicology with clinical development plans and regulatory strategies. Oversee the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal/external partners and/or scientific groups in a concise and meaningful way. Maintain extensive scientific awareness and presence internally and externally, leading initiatives to publish manuscripts and posters, present at scientific conferences and other scientific forums, engage with consultants and advisors in the field, as well as the scientific community at large. In addition to serving as Head of the Nonclinical Safety Evaluation line function, the incumbent may also serve as an independent contributor for a select number of discovery and/or pipeline programs as a Toxicology representative. Here's What You'll Need (Minimum Qualifications) DVM (ACVP board certification preferred) and/or PhD & 15 or more years spent overseeing aspects of nonclinical safety assessment activities in pharmaceutical development. Strong consideration will be given to those with experience in nucleic acid-based and nanoparticle modalities, immune-modulating therapeutics, oncology, and/or infectious disease vaccine drug development. A distinguished reputation in the global scientific community as a Toxicology expert. Experience serving in/managing colleagues serving in the capacity of a Toxicology representative on drug development programs in the pharmaceutical/biotechnology industry and corresponding experience in designing and executing nonclinical toxicology strategies and studies to support clinical development and marketing applications. Experience in mentoring, coaching, and/or managing others on developing nonclinical safety strategies. Direct experience in writing, reviewing, and critiquing nonclinical sections of regulatory submission documents (e.g., INDs/CTAs/BLAs/MAAs, briefing documents, regulatory query responses) and interacting with regulatory agencies. Familiarity with regulatory guidelines for the conduct of nonclinical safety studies to support regulatory filings. Passion for people management, team building, and creative solution seeking for organizational development. Outstanding written and verbal communication skills and the ability to develop and deliver clear and concise presentations for both internal and external stakeholders. Attention to detail and quality, and ability to deliver work on time. Demonstrated ability to work successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and/or strategic directions. Experience in significantly impacting departmental and organizational initiatives that have shaped research strategies. 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 $209,000.00 - $376,000.00. 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-NH1 -
    $71k-97k yearly est. Auto-Apply 41d ago
  • Medical Science Liaison - Oncology - Boston

    Amgen 4.8company rating

    Boston, MA job

    Additional Information All your information will be kept confidential according to EEO guidelines.
    $109k-155k yearly est. 20h ago
  • Associate Director, Biostatistics - Hematology

    Regeneron Pharmaceuticals 4.9company rating

    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 60d+ ago
  • Director, Corporate Counsel - Privacy / Transactions

    Regeneron Pharmaceuticals 4.9company rating

    Cambridge, MA job

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

    Merck 4.6company rating

    Cambridge, 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. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Mirus Bio (now part of MilliporeSigma) is a leading provider of life science products, committed to advancing research, development, and healthcare solutions. We work with top-tier organizations in the life sciences field, providing cutting-edge technologies and expertise. We are seeking an experienced and results-driven Channel Sales Representative to join our team and support the growth of our life science product offerings across a broad network of distribution partners. Your Role: The Channel Sales Representative- Life Science Discovery Products, will be critical in driving sales and expanding the market share for our life science products. This individual will be responsible for building and maintaining strong relationships with distribution partners, managing sales strategies, and identifying new opportunities for growth in the life science sector. The ideal candidate will have experience in sales within the life sciences or healthcare industry and a proven track record of success in channel sales management. Develop and Manage Direct and Distribution Channels: Drive sales for Life Science Discovery and manage relationships with distribution partners in key markets, ensuring alignment with company goals and product offerings. Where appropriate identify and recruit new distributors. Sales Strategy Execution: Work closely with internal teams to develop and implement sales strategies aimed at achieving revenue targets and expanding market presence within the life science sector for both distribution and direct business Product Knowledge: Maintain in-depth knowledge of the company's product portfolio, staying up to date on product advancements and market trends to provide valuable guidance to distributors and clients. Customer Engagement: Provide exceptional support to distribution partners, offering training, troubleshooting, and guidance to ensure their success in selling life science products. Where appropriate, support our direct customer base. Sales Reporting and Forecasting: Track sales performance, provide regular updates, and manage forecasts to ensure accurate revenue predictions and market penetration. Market Analysis: Monitor and assess competitor activities, industry trends, and customer feedback to inform sales strategies and product improvements. Promotional Support: Assist with the creation and execution of marketing and promotional campaigns to enhance product visibility and distributor engagement. Travel: Regular travel to meet with distributors, attend industry events, and gather customer feedback. (20% of the time) Minimum Qualifications: Bachelor's degree in Biology, Chemistry, Business, or other Life Sciences discipline. 3+ years of sales experience, focusing on life science products or related industries like Academia, Biotech, and Pharma Preferred Qualifications: Ideally have a proven track record in managing distribution channels and achieving sales targets. Strong understanding of life science product offerings and their applications. Excellent communication, negotiation, and presentation skills. Ability to work independently and as part of a team in a fast-paced environment. Proficiency with CRM software and MS Office Suite (Excel, Word, PowerPoint). Pay Range for this position: $68,700 - $139,200 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. RSREMD 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!
    $68.7k-139.2k yearly 60d+ ago
  • Undergrad Intern - Operations - Cambridge, MA (Summer 2026)

    Amgen 4.8company rating

    Cambridge, MA job

    Career CategoryCollege JobJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Undergrad Intern - Operations - Cambridge, MA (Summer 2026) What You Will Do Let's do this. Let's change the world. This internship will be approximately 12 weeks that includes both project- based and experiential learning. In conjunction with the project work, you will have the opportunity for professional development through training sessions, one-on-one mentoring, and various networking events. Operations is one of three foundational functions at Amgen with a mission to manufacture and deliver safe and effective medicine to patients around the world. Operations is divided into the following five sub- functions: Supply Chain, Process Development, Quality, Manufacturing, and Facilities & Engineering. We are currently seeking highly motivated, hardworking individuals who will lead initiatives, strategic analysis and business case development on projects across the five Operations functions. During this program, you will focus on making effective recommendations to the organization's senior leadership. Responsibilities include: Develop a project charter to map out objectives, identify key stakeholders, timelines, and deliverables Leveraging your analytical, leadership, and interpersonal skills, you will work cross-functionally to identify the problem, measure the current state, develop recommendations through qualitative and quantitative analysis, and present the findings through various forums including an intern-wide poster session and a final readout to executive management Network with colleagues across the company and enjoy full access to Amgen's Employee Resource Groups What We Expect of You We are all different, yet we all use our unique contributions to serve patients. The passionate and driven individual we seek exemplifies the following qualifications: Basic Qualifications: Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria: 18 years or older Currently enrolled in a full-time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent Completion of one year of study from an accredited college or university prior to the internship commencing Enrolled in a full-time Bachelor's degree program following the potential internship or co-op assignment with an accredited college or university Must not be employed at the time the internship starts Student must be located in the United States for the duration of the internship or co-op Preferred Qualifications Junior standing with graduation in Summer 2027 Degree concentration(s) in Engineering, Life Science, Chemistry / Chemical Engineering, Biotechnology, Applied Mathematics or Data Science Strong knowledge of MS Office Applications (Word, Excel, PowerPoint, SharePoint) VBA for Excel and SQL knowledge Strong communication, interpersonal, organizational, project management, problem solving, analytical and quantitative skills Demonstrated personal initiative, self-motivation, flexibility and adaptability Proven leadership experience on campus (e.g., projects, clubs, organizations, sports) What You Can Expect of Us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth in addition to their well-being: The base pay range for this opportunity in the U.S. is $24.70 - $28.30 an hour. Build a network of colleagues that will endure and grow throughout your time with us and beyond. Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities. Participate in executive and social networking events, as well as community volunteer projects. Apply now and make a lasting impact with the Amgen team. careers.amgen.com Please search for Keyword R-223937 In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range -
    $24.7-28.3 hourly Auto-Apply 60d+ ago
  • Process Development Sr. Associate - Drug Product Technology

    Amgen 4.8company rating

    Cambridge, MA job

    Career CategoryOperationsJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Sr. Associate - Drug Product Technology What you will do Let's do this. Let's change the world. In this vital role you will join the Pre-Pivotal Drug Product, Synthetics Enabling Technologies (SET) team and support the characterization and development of small molecule drug candidates. This role is primarily laboratory-based and focuses on understanding physicochemical and biopharmaceutical properties that impact formulation design, stability, and oral bioavailability. The candidate will work closely with scientists on molecule assessment, solid-state characterization, and analytical teams to support early development programs. Key Responsibilities include: Conduct physicochemical profiling of small molecule drug candidates (e.g., solubility, pKa, logP/logD, hygroscopicity, dissolution, and chemical stability). Assess developability risks by integrating experimental data on molecular properties. Support material characterization to guide form selection and formulation strategy. Perform solid-state analysis including X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), FT-IR, Raman spectroscopy, and solid-state NMR (as applicable). Execute manual and automated high-throughput screening workflows. Prepare and characterize preclinical formulations (solutions, suspensions, solid dispersions, etc.) to enable in vivo studies. Maintain accurate, detailed experimental records in electronic laboratory notebooks (ELN). Document and interpret data to support regulatory filings and internal reports. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative individual with these qualifications. Basic Qualifications: High school diploma / GED and 6 years of Scientific experience OR Associate's degree and 4 years of Scientific experience OR Bachelor's degree and 2 years of Scientific experience OR Master's degree Preferred Qualifications: B.S. in Chemistry, Chemical Engineering, Materials Science, Pharmaceutical Science, or a related scientific field, with at least two years of pharmaceutical/biotech industry experience. Hands-on experience with solid-state and preformulation techniques. Familiarity with data interpretation from XRPD, DSC, TGA, and spectroscopic methods. Experience with high-throughput screening or automated liquid handling is desirable. Strong attention to detail and commitment to data quality. Effective communication and teamwork skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 85,306.00 USD - 103,484.00 USD
    $74k-89k yearly est. Auto-Apply 48d ago
  • Program Leader Network Transformation

    Johnson & Johnson 4.7company rating

    Raynham, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Project/Program Management Group Job Sub Function: Project/Program Management Job Category: Professional All Job Posting Locations: Leeds, West Yorkshire, United Kingdom, Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Ringaskiddy, Cork, Ireland Job Description: Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. General Summary Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world. Having made significant contributions to healthcare for more than a century, the Johnson & Johnson Medical Devices Companies are in the business of reaching more patients and restoring more lives. The group represents the most comprehensive surgical technology and specialty solutions business in the world, offering an unparalleled breadth of products, services, programs and research and development capabilities directed at advancing patient care while delivering clinical and economic value to health care systems worldwide. DePuySynthes, is recruiting for a Network Transformation Program Leader, as part of the Network Transformation Group to be located in Raynham, MA, Palm Beach Gardens, FL, Leeds, UK, or Cork, Ireland. This individual will be responsible for supporting the design and execution of the Network Strategy Programs focusing on the Joints Platform. Principal Roles and Responsibilities * Design, development and execution of Strategic Network Development Programs * Development and submission of Business Cases for Network TransformationProvide strategic leadership managing vision and purpose which support organization, functional and program goals. * Delivery of Network Transformation Metrics, including design, tracking, mitigation and reporting in line with business commitments * Conduct program reviews with Supply Chain Leadership Team and other executive stakeholders as required. * Lead and develop several cross-functional teams in the execution of strategic supply chain programs to deliver committed business metrics * Support of Supply Chain Digital Strategy to enable optimization of critical Supply Chain Processes * Partner closely with Finance to ensure Financial planning and tracking is in place for all programs * Partner closely with Regulatory, Operations, Operations, Plan, Network Teams to ensure execution of the strategy development programs * Manage initiatives effectively, timely, and on budget while minimizing any impact to base business, customer service and employee engagement. Manage competing demands relevant to scope, schedule, cost, risk and quality, and differing stakeholder requirements and expectations to satisfy outcomes. * Create and deliver presentations to Senior Stakeholders / Business Leaders on project business cases, goals, plans, issues and risks, including progress reports, mitigation and contingency plans. * Develop and revise project plans, work with stakeholders to understand complex problems and focus on bringing issues to resolution in a timely manner, escalating as necessary to meet timelines. * Develop future state business case proposals for additional actions which drive supply chain resilience, agility and financial value. Qualifications * A minimum of a Bachelor's degree required; Bachelor of Science degree in Engineering, Supply Chain, Finance, Operations or related field highly preferred; Advanced degree such as a M.S. or MBA preferred * A minimum of 10+ years of related experience required * Project management experience required * Demonstrated experience of Business Case development for Supply Chain Programs * Strong knowledge of E2E Orthopaedics product supply, manufacturing and distribution * Demonstrated knowledge and expertise in bridging technical and business disciplines * Lean manufacturing and six-sigma methodology experience preferred * Product cost management and budget management preferred * Up to 25% of travel both domestically and internationally is required We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Don't miss this exceptional opportunity to join a world-class company and make a lasting impact. Apply now and be part of our ambitious team! Required Skills: Preferred Skills: Agile Decision Making, Agility Jumps, Analytics Insights, Budget Management, Business Behavior, Business Savvy, Continuous Improvement, Leadership, Organizational Project Management, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Statement of Work (SOW), Tactical Planning, Technical Credibility
    $111k-140k yearly est. Auto-Apply 7d ago
  • Director CMC Statistics

    Amgen 4.8company rating

    Cambridge, MA job

    Career CategoryQualityJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director, CMC Modeling & Advanced Statistics What you will do Let's do this. Let's change the world. In this vital role, you will serve as Amgen's leader in advanced statistical modeling for CMC development and commercial support. Reporting to the Senior Director, CMC Statistics, you will drive innovation in kinetic modeling, Bayesian statistics, and predictive methods to accelerate decision-making across Amgen's product portfolio. You will also ensure best-in-class application of advanced modeling techniques to CMC data, spanning drug substance, drug product, and delivery device development. As Director, CMC Modeling & Advanced Statistics, you will: Provide strategic and technical leadership in the design and implementation of kinetic modeling, Bayesian methods, and predictive analytics to support product and process characterization, stability modeling, and specification setting. Lead development and application of statistical/mathematical models to optimize manufacturing processes, evaluate product lifecycle and stability data, and support regulatory submissions. Champion the integration of Bayesian methods and modeling frameworks to enhance data utilization, manage uncertainty, and improve decision-making across the CMC lifecycle. Partner with cross-functional teams (Process Development, Analytical Sciences, Quality, Manufacturing, and Regulatory) to ensure modeling strategies are aligned with Amgen's business and scientific objectives. Contribute to regulatory strategies by developing and defending modeling-based justifications in submissions and at regulatory authority interactions. Advance Amgen's digital and data science strategy by incorporating machine learning, simulation, AI, and automation approaches into statistical workflows. Represent Amgen externally through scientific collaborations, publications, and conference presentations to establish thought leadership in CMC modeling. Train & guide other statisticians & data scientists in the use of innovative statistical approaches, including but not limited to kinetic, Bayesian, and predictive modeling What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of relevant biopharmaceutical industry experience OR Master's degree and 8 years of relevant biopharmaceutical industry experience OR Bachelor's degree and 10 years of relevant biopharmaceutical industry experience In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Degree in Statistics, Biostatistics, Applied Mathematics, Engineering, or related quantitative field. Deep expertise in kinetic modeling, Bayesian methods, and advanced statistical modeling techniques. Strong track record of applying statistical modeling to CMC data, including stability, comparability, process characterization, and analytical method development. Proficiency with statistical software (e.g., R, SAS, JMP, Minitab) and modeling tools (e.g., NONMEM, MATLAB, Stan, or similar Bayesian frameworks). Demonstrated success influencing regulatory strategies through modeling-based approaches. Proven ability to lead and develop technical talent in statistics and modeling. Excellent oral and written communication skills, with ability to explain complex modeling approaches to both technical and non-technical audiences. Experience working in cross-functional and global team environments. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 207,002.00 USD - 238,637.00 USD
    $100k-131k yearly est. Auto-Apply 37d ago
  • Senior Data Scientist

    Amgen Inc. 4.8company rating

    Cambridge, MA job

    Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Data Scientist What you will do Let's do this! Let's change the world! In this vital role you will be responsible for developing, maintaining and deploying first principles and/or machine learning models for biopharmaceutical processes, including and not limited to cell line development, cell culture, biologics formulation development, fill/finish processes where having a fundamental understanding of bioprocessing would be preferred. You will be responsible for the selection of the underlying technologies and infrastructure. Finally, you will enable dataflow from our centralized data lake to computational models. The ideal candidate will have a strong background in chemical engineering as well as expertise in data science to tackle challenging cross‐functional projects including first principles modeling, machine learning, machine learning and first principles hybrid model development, computer vision, data analysis and visualization. The candidate will be part of cross functional project teams with frequent interactions with Amgen's SMEs and stakeholders as well as document and communicate the underlying technical basis of the models for the benefit of and use by engineers and scientists. * Design, develop, and deploy first principles and machine learning models to optimize biopharmaceutical processes. * Apply hybrid modeling approaches that combine machine learning, first-principles modeling, and computer vision to improve process understanding and performance. * Build and maintain robust data pipelines from centralized data lakes to computational models, ensuring high data quality and accessibility. * Collaborate with cross-functional teams to translate scientific challenges into data-driven solutions and ensure seamless model integration into process development workflows. * Champion best practices in software development, including version control, testing, and continuous integration to ensure model reliability, scalability, and reproducibility. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Data Sciences professional we seek is an individual with these qualifications. Basic Qualifications: * High school diploma / GED and 10 years of Data Sciences experience OR * Associate's degree and 8 years of Data Sciences experience OR * Bachelor's degree and 4 years of Data Sciences experience OR * Master's degree and 2 years of Data Sciences experience OR * Doctorate degree Preferred Qualifications: * Ph.D. in Chemical Engineering or related field. * Track record of leading data science, first principles and machine learning modeling projects * 4+ yrs of coding experience in Python * Engineering or science background with strong first principles modeling and ML skills * Experience in AI and ML algorithms * Understanding of biopharmaceuticals process and related unit operations. * Experience using Git for version control * Familiarity with DevOps and software best practices (i.e., version control, continuous integration, test driven development) * Experience in Databricks, Spotfire * Experience in cloud computing and storage systems such as AWS. * Independent, self‐motivated, organized, able to multi‐task in time‐sensitive environments, and skilled in communication, facilitation, and collaboration * Excellent communication skills (written and verbal) * Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy. What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans * Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 137,855.00 USD - 168,574.00 USD
    $94k-123k yearly est. 14d ago
  • Scientist, Clinical Biomarker Laboratory, Flow Cytometry

    Moderna 4.8company rating

    Moderna job in Norwood, MA

    The Role: Moderna is seeking a motivated and skilled Scientist to join the Clinical Flow Cytometry group. This individual will serve as the Cytometer Instrument Lead while also executing clinical testing, assay/panel development, and validation activities under GCLP guidelines. The Scientist will work with a team of scientists to deliver high-quality biomarker data to support clinical programs across multiple therapeutic areas. The successful candidate will have strong technical expertise in spectral flow cytometry instrumentation (Cytek Aurora), along with experience in developing, validating, and executing flow cytometry-based assays. This role requires deep understanding of immunology, experience in clinical laboratory environments, and the ability to apply best practices in translational and clinical sample testing. You will be an integral part in applying high parameter flow and complex assays to generate key clinical data to drive clinical trial decisions. Here's What You'll Do: Serve as an internal technical expert (Instrument Lead) for flow cytometry instrumentation, operation, and maintenance. Ensure all cytometers are harmonized to generate equivalent data, remain ready for clinical acquisition, adhere to stringent QC program and that all documentation meets GCLP Compliance needs and is available in the event of internal or external audit. Identify and troubleshoot instrumentation, assay, or workflow issues; implement mitigation strategies to avoid downtime or data loss. Responsible for Data Management and database backups adhering to GCLP Compliance and Regulatory needs Work with and guide Global Instrument Leads on maintenance, harmonization, and documentation practices. Train and mentor junior staff in flow cytometry methods, instrumentation, and assay execution. Execute clinical sample testing under GCLP guidelines, including PBMC and whole blood processing, staining, and high-parameter immunophenotyping. Adhere to established experimental workflows and documentation procedures while working to improve processes and documents for accuracy and efficiency. Design, develop, and optimize multiparameter flow cytometry panels and assays, including ex vivo functional profiling (e.g., intracellular cytokine staining, proliferation, cell activation). Lead or support assay fit-for-purpose qualification and validation to ensure compliance with clinical standards. Perform data acquisition, gating analysis (FCS Express), interpretation, and reporting of study data. Contribute to analytical study documentation including SOPs, study plans, and study reports as needed. Stay current with emerging technologies, reagents, and industry best practices in clinical cytometry. Occasionally the job may require overtime work or weekend shift as needed Here's What You'll Bring to the Table: Ph.D., MS or BS in Immunology, Life Sciences, Biology, or related field; 5yr+ experience in translational/clinical biomarker flow cytometry Strong expertise with flow cytometry instrumentation (Cytek Aurora, BD Symphony/Fortessa, or equivalent) including set-up, troubleshooting, and routine maintenance. Proven experience in clinical laboratory environments with adherence to GCLP or other regulated standards. Demonstrated success in designing, developing, and validating multiparameter flow cytometry assays for clinical applications. Hands-on experience in immunology-based functional assays (intracellular cytokine staining, T cell immunophenotyping, receptor occupancy assays). High proficiency with flow cytometry analysis software (FCS Express, FlowJo, OMIQ) and data interpretation. Strong organizational, computational, and documentation skills (Excel, GraphPad Prism, PowerPoint, Word). Excellent written, presentation, and interpersonal communication skills; ability to collaborate effectively across teams and with external partners. Track record of flexibility, problem-solving, and adaptability to shifting priorities in a fast-paced environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 -
    $54k-71k yearly est. Auto-Apply 41d ago
  • Principal Human Factors Engineer, Abiomed

    Johnson & Johnson 4.7company rating

    Danvers, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: Industrial Design & Human Factors Job Category: Scientific/Technology All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: Johnson & Johnson is hiring for a Principal Human Factors Engineer - Abiomed to join our team located in Danvers, Massachusetts. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech ABOUT US: Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. Patients First | Innovation | Winning Culture | Heart Recovery POSITION SUMMARY Our Human Factors Engineers and Designers are focused on improving patient outcomes through better usability, rapidly developing next generation products for heart recovery by placing our users at the center of our design process. * We develop solutions that balance the needs of various users; surgeons, physicians, hospital staff, patients and caregivers. * Our team works across all global Abiomed platforms striving for best practice usability and true human centered design. KEY RESPONSIBILITIES: The Principal Human Factors Engineer will: * Influence the HF/Usability strategy and contribute to human factors efforts for programs from concept through post market support, supporting usability activities for all product lines and programs with minimal oversight. * Develop an understanding of intended use environments gained through good understanding of intended user types formed through interactions with users. * Work on problems of diverse scope that impact the broader program team and business and leads projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for creating risk mitigations and associated evaluations. * Mentor other engineers on project, and supervise/direct third party contractors/consultants; including reviews of deliverables to ensure accuracy * Network with key contacts outside own area of expertise, contributes to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development REQUIREMENTS: * University/bachelor's degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, or Equivalent; Post-Graduate Degrees (MS) are a plus. * Minimum of 8 years' work experience in human factors / usability engineering experience or equivalent experience in product development and customer interactions is required. Medical Device product development or experience working in a highly regulated industry is a strong plus. * Demonstrated proficiency with the human factors engineering process (research, planning, risk assessment, and regulatory submissions) and principles (task and use-related risk and root cause analysis methods). * Expertise in planning, executing (including moderation), documenting, and reporting usability testing including consolidating user feedback into concise, meaningful design insights and actionable recommendations. * Basic knowledge of anthropometrics, biomechanics, and physiology is preferred. * Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for improvement * In depth knowledge of FDA, ISO, AAMI, and other relevant usability regulations and standards. Knowledge of the ISO 14971 and IEC 62304 are a plus. * Fluent in English. German is an advantage. * Ability to travel up to 5%, domestic and international is required. Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $117,000 - $234,000 The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year. Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year. Holiday pay, including Floating Holidays - up to 13 days per calendar year. Work, Personal and Family Time - up to 40 hours per calendar year. For additional general information on Company benefits, please go to: - ********************************************* #LI-Onsite Required Skills: Collaborating, Communication, Compliance Management, Innovation, Problem Solving Preferred Skills: Analytical Reasoning, Coaching, Concept Testing, Critical Thinking, Customer Intelligence, Human Factor Engineering, Industry Analysis, Organizing, Product Design, Product Improvements, Product Portfolio Management, Product Strategies, Product Testing, Prototyping, Research and Development, Risk Management, SAP Product Lifecycle Management, Technical Credibility The anticipated base pay range for this position is : US : $117,000.00 - $234,000.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $117k-234k yearly Auto-Apply 9d ago
  • Process Development Principal Scientist

    Amgen Inc. 4.8company rating

    Cambridge, MA job

    Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Principal Scientist What you will do Let's do this! Let's change the world! In this pivotal role within Amgen's Commercial Drug Product Technologies group, you will be responsible for process development and lifecycle management of commercial drug product formulation and fill/finish processes across various modalities. You will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization and life-cycle of the products. Role Responsibilities: * Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of both parenteral and oral solid dosage presentations * Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements. * Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering. * Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and cultivate strong relationships. * Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions. * Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs. * Actively utilize advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis. * Ability to travel domestically and internationally up to 10% of the time. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative leader with these qualifications. Basic Qualifications: * Bachelor's degree and 7 years of Scientific experience OR * Master's degree and 5 years of Scientific experience OR * Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of Scientific experience Preferred Qualifications: * Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related subject area * 5+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field * Knowledge of/hands-on experience with end-to-end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations * Knowledge and awareness of the regulations governing combination product development * Experience with parenteral biologics (i.e. filling, filtration, mixing, etc.) process characterization, scale-up, and commercial manufacturing * Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability * Aseptic processing experience and familiarity with cGMPs, ICH guidelines, and pre-approval inspection/audits * Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments * Strong problem solving and effective interpersonal skills, and the ability to influence colleagues with ideas. * Previous scientific and managerial experience in support of drug product development, investigations, and regulatory filings is important. * Ability to learn and rapidly react in an environment with dynamic information. What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans * Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 148,363.00 USD - 171,657.00 USD
    $90k-116k yearly est. 16d ago
  • Sr Associate Process Development

    Amgen 4.8company rating

    Cambridge, MA job

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Sr Associate Process Development** **What you will do** Let's do this! Let's change the world! Amgen is a global leader in biotechnology, pioneering innovative medicines and cutting-edge manufacturing for over four decades. Our mission: to serve patients through science and technology. We're looking for a Senior Associate, Process Development at our Cambridge Process Development Pilot Plant ("Scale-Up Lab")-a hands-on innovator ready to drive Amgen's mission forward. In this role, you'll design, develop, and optimize manufacturing processes up to the 2000L scale, lead pilot-scale experiments, and implement process improvements that enhance product quality and efficiency. You'll also help guide junior staff, ensure production excellence, and champion new technologies and automation initiatives. Working in an integrated cell culture and purification organization, you'll contribute to advancing a diverse pipeline-from antibodies to oncolytic viruses to bispecifics. This role blends technical expertise, creativity, and leadership, offering exposure to both upstream and downstream operations and next-generation equipment. You'll tackle real-world challenges daily-troubleshooting, problem-solving, and innovating at the interface of biology and engineering. The pilot plant environment enables you to test and scale new technologies, support technology transfers, and deliver critical data for early and late-stage biologics. The ideal candidate brings a strong foundation in large-scale bioprocessing (upstream and downstream), proven leadership, and a track record of operational excellence-plus a curiosity for data science is a bonus. Join us to build the platforms of the future and make a lasting impact on patients worldwide. Your core scope of responsibilities will include managing new product introductions, leading team meetings, participating in experiment and equipment design, authoring, and reviewing standard operating procedures and manufacturing instructions, among other documents. **Other responsibilities include:** + Setup, execute, monitor, and troubleshoot cell culture, harvest, and purification operations up to the 500L pilot plant scale utilizing such equipment as rocking and single-use bioreactors, and single-use chromatography and filtration systems (TFF, VF, UFDF). + Perform in-process sampling and prepare buffers/media per defined manufacturing procedures as needed. + Pack and qualify chromatography columns up to 40 cm in diameter. + Document work in electronic lab notebooks per GDP principles while following appropriate SOPs. + Generate, analyze, and summarize process data to identify and mitigate challenges to future commercial processes, and support new technology development, new product introductions, and facility tech transfers. + Write, review & revise documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc). + Use digital tools such as Biovia Workbook, Emerson DeltaV, PI Vision, Smartsheet, Spotfire, Tableau, and the Microsoft suite (Outlook, Word, Excel, PowerPoint, Visio, SharePoint, Teams). + Maintaining an organized and clean workspace. + Identifying, recommending, and implementing improvements related to routine functions + Performing activities that include periods of rigorous, repetitive work. + Working safely around high-pressure systems and heavy equipment. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. **Basic Qualifications:** + High school diploma / GED and 6 years of Scientific experience OR + Associate's degree and 4 years of Scientific experience OR + Bachelor's degree and 2 years of Scientific experience OR + Master's degree **Preferred Qualifications:** + Application of process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to everyday tasks. + Adherence to all regulatory requirements, written procedures, policies, and safety guidelines at all times. + Ability to organize work, handle multiple priorities, and meet deadlines. + Ability to interpret and apply GDP, FAIR, and ALCOA+ principles to everyday work. + Identify, recommend, and implement improvements related to routine functions (facilitate the drive towards continuous improvement in the plant). + Maintain an organized and clean workspace. Contributes to general housekeeping and 5S initiatives. + Demonstrates a sense of ownership and pride in work performed. + Demonstrate the Amgen Values and contribute to a culture of safety. + Ability to work in teams to complete operational tasks in a timely manner. + Creates a positive work environment through interactions with team members. + Ability to take initiative, follow up, ask questions and always act with honesty and integrity. + Ability to regularly lift up to 35 lbs, push and pull objects that require up to 50 lbs of force, and work on your feet for long durations. + Ability to perform physical movements to perform daily tasks on the production floor such as bending, reaching above the head, climbing, kneeling, squatting, stooping, walking up or down stairs, and standing on portable stairs or ladders up to 6 feet off the ground. + Ability to work some off-hours and weekends due to the nature of the work. **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Sponsorship** Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $82k-109k yearly est. 15d ago
  • Thought Leader Liaison (TLL) - Senior Manager, Northeast

    Amgen 4.8company rating

    Boston, MA job

    Career CategorySales & Marketing OperationsJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Dermatology Thought Leader Liaison Sr. Manager, Northeast Live What you will do Let's do this. Let's change the world! This critical role will focus on maintaining and building relationships with external Opinion Leaders and large medical centers in Dermatology. The Northeast Thought Leader Liaison (TLL) Sr. Manager will report into the Director of Professional Relations with a dotted line to the East Regional Sales Director. They will join the National team of Dermatology Thought Leader Liaisons in the inflammation Business Unit. The TLL will be a critical member of the Otezla Brand Marketing Team and will coordinate closely with the Otezla field sales team. The TLL will be responsible for the following, but not limited to: OL Development and Management Identify, cultivate, and maintain professional relationships with established and up-and-coming regional Opinion Leaders in Dermatology Work cross functionally to drive and develop aligned external engagement strategies across multiple cross functional teams including medical, training, marketing, and sales Manage OL Speaker bureau relationships including supporting speaker training, compliance, and product theater speaker management Manage regional speaker bureau, including providing speaker recommendations Identify and manage relationships with key national Dermatology Accounts and Psoriasis Centers Conference Management Attend and manage brand activity at key regional and national Dermatology conferences, including managing product theaters, and other ancillary brand activities Manage overall regional sponsorship budget, including working with organizations to secure sponsorships, and owning regional congress plan Coordinate executive meetings with OLs at national conferences Complete all necessary conference and speaker contract requirements in a timely manner Coordinate with marketing to ensure all congress materials are delivered on time Coordinate with sales and marketing Coordinate closely with the sales team to ensure alignment with conference OL engagement plan as well as other OL/account engagement Provide customer and market insights back to the marketing team and provide input into P2P development, advisory boards, and strategy Partner with the HCP Marketing team to develop advisory board strategy, content, advisory recommendations, and attend advisory boards as appropriate Provide insights summary from key congresses to the marketing team Additional Information: Significant business travel, by air or car, is regularly required (Greater than 50%) Willingness to work evenings and select weekends is required Located near a hub airport is recommended Role covers the Northeast United States; NY, MD, MA, WV, OH, MI, CT, PA, ME, RI Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The marketing professional we seek is a collaborative partner with these qualifications. Basic Qualifications: Doctorate degree and 2 years of marketing or sales experience Or Master's degree and 4 years of marketing or sales experience Or Bachelor's degree and 6 years of marketing or sales experience Or Associates degree and 10 years of marketing or sales experience Or High school diploma / GED and 12 years of marketing or sales experience Preferred Qualifications: 5+ years of experience working in Dermatology in sales or marketing roles Prior experience in thought leader engagement, regional marketing, sales, or sales leadership Strong relationship building skills, with proven ability to build and maintain lasting relationships with OLs Ability to exercise strong decision-making skills and live up to the highest ethical standards. Excellent written and verbal communication skills Ability to build productive partnerships and collaborate effectively in a matrix organization. Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com. Salary Range 191,816.00 USD - 220,550.00 USD
    $130k-170k yearly est. Auto-Apply 30d ago
  • Senior Systems Engineer

    Amgen Inc. 4.8company rating

    Cambridge, MA job

    Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Systems Engineer What you will do Let's do this! Let's change the world! The Senior Systems Engineer leads development activities within a cross-functional program team to create the technical content, performance, intellectual property and quality deliverables of a combination product (device/biologic combination) development program. This role leads the capture of user needs and translation into system requirements and is also responsible for the functional decomposition and allocation to subsystems. The Senior Systems Engineer owns respective systems engineering deliverables and ensures that the quality targets are satisfied, identifies and communicates technical risks and coordinates risk retirement activities on the program. Also, maintains close cross-functional interaction within Amgen to deliver on customer satisfaction through high product quality. Responsibilities: * Provide leadership and support for requirements management for large or complex development programs. * Lead the development, execution and review of requirements (within an electronic requirements management system), design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. * Lead the creation and assessment of product requirements to determine technical coverage and proper integration different subsystems of combination products through consideration of the system as a whole, rather than individual components of the system. * Work cross-functionally with individuals and project teams in Marketing, Operations, Manufacturing and Development. * Oversight of characterization or feasibility testing as well as computer simulations. * Utilize project planning and monitoring methods to ensure timely completion. * Review and approve completed design documentation. * Mentor junior engineers What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: * High school diploma / GED and 10 years of directly related engineering experience OR * Associate's degree and 8 years of directly related engineering experience OR * Bachelor's degree and 4 years of directly related engineering experience OR * Master's degree and 2 years of directly related engineering experience OR * Doctorate degree Preferred Qualifications: * 6+ years of progressive experience as an engineer within the appropriate field of study. * 5+ years of experience in product development working with mechanical medical devices, ideally combination products (device/biologics combination). * Formal Systems Engineering training/certification. * Demonstrated applied lean 6 Sigma competency. * Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues. * Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.) * Leadership ability for system-level design and testing (Verification and Validation testing of System Level Performance). * Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position. * Familiar with the following standards: * Needle-based Injection Systems - ISO 11608-1 * Prefilled Syringe Systems - ISO 11040 * Quality Management - ISO 13485 * Risk Management - ISO 14971 * EU Medical Device Regulation * Strong background in documenting requirements and providing traceability documentation for regulatory approval - Dassault 3DS, DOORS or other similar electronic requirements management software. * Practical experience in configuration management and change control process/requirements - CCB (change control board), CIT (change implementation team) concepts. * Strong interpersonal skills. What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans * Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 119,195.00 USD - 147,867.00 USD
    $97k-120k yearly est. 21d ago
  • Director, R&D Team Effectiveness Center of Excellence

    Johnson & Johnson 4.7company rating

    Cambridge, MA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Human Resources Job Sub Function: Learning & Instructional Design Job Category: Professional All Job Posting Locations: Cambridge, Massachusetts, United States of America, La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: We are searching for the best talent for our Director - R&D Team Effectiveness Center of Excellence position, to be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Cambridge, MA; or La Jolla, CA. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine Purpose: The Director for the Team Effectiveness Center of Excellence inside Innovative Medicine R&D is part of the Strategy, Portfolio, & Operations organization (SP&O). This role is an active leader in achieving the outcomes for SP&O's Learning, Development, and Change Readiness strategic pillar: adaptable and empowered R&D teams and team systems, building individual capabilities to enable performance and development, and successful implementation and adoption of R&D transformation. This role will be responsible for building team-level capabilities and leading the design, development, and implementation of comprehensive team development strategies that enhance team capabilities, team effectiveness, and team performance across Innovative Medicine R&D. This role provides strategic leadership and oversight for the Team Effectiveness Center of Expertise inside Innovative Medicine R&D, ensuring alignment with R&D Goals & Objectives and driving excellence in operating model design, governance, and capability building. This role aligns team effectiveness approaches across several team and teaming constructs across J&J, Innovative Medicine, and R&D, and applies external research and evidence-based practices on team effectiveness and development. This role drives adaptive teaming best practices across the organization, and leads the continuous evolution of team practices to support changes in drug development This role publicizes best practices, use cases & learnings across the various organizations & communities, and disseminates teaming practices owned by the CoE. This position will have accountability for the measurement of progress, outcomes & business impacts from teaming solutions and initiatives, as well as govern teaming standards & practices. You will be responsible for: * Strategy Development: Design and implement innovative teaming strategies that align with R&D and organizational objectives. Partners with leaders in R&D and governance committees to gain sponsorship and momentum for these strategies. * Team Capability Program Management: Oversee the development, delivery, and evaluation of teaming programs to capabilities across R&D and IM Teaming ecosystems. * Needs Assessment: Conduct regular assessments to identify needs and gaps in critical teams or teaming systems, ensuring solutions are adaptable and scalable to address these needs * Partnerships: Establish partnerships with internal organizations supporting Learning & Development work across R&D, GCSO, HR, and Global Talent Management. * Metrics and Analysis: Develop and implement metrics and dashboards to measure the effectiveness of teaming programs and overall impact on R&D performance * Collaboration: Partner with senior leaders and HR teams to integrate teaming initiatives within major teaming systems and R&D talent and organizational strategies. Leads the R&D Teaming Community and aligns efforts across teaming practitioners in IM R&D * Leadership Development: Create and facilitate programs aimed at building leadership capabilities in the context of cross-functional and matrix teams. * People Leadership: Provide leadership and coaching to internal learning and development team (either JNJ or contractor colleagues), promoting a collaborative environment and high performance Qualifications / Requirements: * Bachelor's degree in Human Resources, Business Administration, Life Sciences, Learning & Development, Education, Psychology, Organizational Development, or a related field. Master's Degree preferred. * 10 years of progressive experience in Learning, Training, Organizational Design, Team Development, Organizational Development, Leadership Development, or Human Resources within the pharmaceutical or life sciences sector. * 5 years of people management experience. * Proven experience with programmatic approaches to develop intact teams, cohorts of teams, and teaming systems. * Expert facilitation skills with team-level interventions, with the adaptability to make agile shifts in-flight * Proven experience in performance consulting to identify gaps in teams and teaming systems, and and recommend solutions. * Strong knowledge of adult learning principles, instructional design, learning technologies and methodologies, and program evaluation. * Integrates change readiness principles to effectively identify key barriers and implement solutions to achieve change implementation and realization * Proven ability to manage multiple projects simultaneously and deliver on-time results. * Ability to analyze data to inform training strategies and improve program effectiveness. * Exceptional verbal and written communication skills, with the ability to present complex information clearly. * Strong interpersonal and persuasion skills that allow for effective collaboration with stakeholders at all levels Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid Required Skills: Preferred Skills: Adult Learning Theory, Assessment Models, Coaching, Cultural Competence, Facilitation, HR Strategic Management, Instructional Design, Instructional Development, Learning and Development (L&D), Learning Culture, Quality Assurance (QA), Reporting and Analysis, Tactical Planning, Talent Management, Technical Credibility, Training Delivery Methods, Training Needs Analysis (TNA) The anticipated base pay range for this position is : $150,000-$258,750 Additional Description for Pay Transparency: The expected base pay range for this position is $150,000-$258,750. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on December 3, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.
    $150k-258.8k yearly Auto-Apply 9d ago

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