Sumitomo Corporation jobs in Boston, MA - 117 jobs

Director, Commercial Manufacturing Validation
Sumitomo Pharma 4.6
Sumitomo Pharma job in Providence, RI
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
$173.2k-216.5k yearly 30d ago

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Senior Medical Science Liaison - Biopharma (NY/NJ/Eastern PA/CT)
Sumitomo Pharma 4.6
Sumitomo Pharma job in Marlborough, MA
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Medical Science Liaison. The Senior Medical Science Liaison will be responsible for integrating scientific expertise and knowledge with brand strategies to ensure successful implementation of Sumitomo Pharma America's marketed and emerging product portfolio. This will be fulfilled mainly through the development of excellent working relationships with key opinion leaders and regional clinicians of influence. Job Duties and Responsibilities Identify key national and regional, and local urology and women's health thought leaders and priority customers, build and maintain advocacy with these individuals, and function as their primary scientific contact. Participate in the collection and exchange of scientific/technical information important to the Company's market and development portfolio. Assist in the management of relationships between key opinion leaders and corporate product teams, as well as provide education of priority customers on research and development projects. Accumulate key competitive information to aid the clinical and marketing teams in drug/brand development. Identify, initiate, coordinate, evaluate and monitor investigator-sponsored studies intended to support the clinical and scientific strategy of the Company's products. Help develop and manage timelines of publication plans of investigator-sponsored studies. Assist in the identification, evaluation, and engagement of potential investigators for corporate trials. Assist the clinical trials team, as needed, in the ongoing support and communication with investigators on corporate trials. Develop key advocates as speakers to support the Company's products and strategies. Assist in the development of, and participate in, advisory boards and medical education programs. Contribute scientific and clinical expertise to the development and execution of commercial educational activities. Provide clinical resources for programs supporting sales/sales training and marketing efforts and professional services. Represent the Company at national, regional, and local urology and women's health meetings and conferences. Maintain clinical and technical expertise in the area of urology and women's health through review of the scientific literature and attendance at key scientific meetings. Leads assigned projects within the MSL organization. Perform other duties as assigned. Key Core Competencies Patient care clinical experience or strong scientific research experience in the therapeutic area (Urology and Women's Health) preferred. Strong project leadership and management history required. Ability to efficiently manage time and priorities. Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction. Understanding of drug development and life-cycle development of a product. Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders; the ability to work effectively with key decision makers, both within and outside the Company. Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building. Ability to understand and translate external customer and/or internal client needs into effective decisions and to drive results and strive for continuous improvement with high performance in the face of adversity a must. Willingness to travel >50% of the time within the domestic US. Education and Experience Required Bachelors Degree in a related field Minimum of 5 years of relevant scientific or clinical experience in Urology/Women's Health Minimum 0 - 3 years of relevant experience in biotech or pharmaceutical industry 1-3 years of MSL experience in Urology/Women's Health preferred. Advanced degree in medical science (MD, PharmD, or PhD) is strongly preferred. Candidates without an advanced degree are required to have at least 5 years of industry MSL experience, and 6-10 years overall related experience. The base salary range for this role is $175,680 to $219,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
$175.7k-219.6k yearly Auto-Apply 60d+ ago
Events Marketing, Internship Boston, MA
Haemonetics 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Job Details Internship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The Rise of Authentic Experiences: AI's Role in Elevating In-Person Events and Performance Strategy Internship will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St. The Summer 2026 Internship is a 12-week program that requires a commitment to start on June 1st and stay through August 21st. Market Engagement Services (MES) is a centralized, strategic marketing enablement team that strengthens marketing effectiveness by optimizing resources, streamlining processes, and expanding reach to drive measurable commercial demand across Haemonetics' Business Units through a programmatic approach. The Rise of Authentic Experiences: AI's Role in Elevating In-Person Events and Performance Strategy examines how artificial intelligence is transforming the event landscape while reinforcing the growing importance of genuine, human-to-human interaction at live experiences. As digital and AI-driven touchpoints increase, this project explores how in-person events deliver credibility, trust, and authenticity that cannot be replicated online, and how AI can be leveraged to enhance - not replace - these moments through smarter personalization, real-time insights, and performance analytics. By analyzing attendee engagement, event effectiveness, and measurable ROI, the project will identify strategic ways to use AI and data to optimize event planning and execution, strengthen authentic connections, and maximize impact across both physical and digital event environments. Required / Preferred Degree Type: Preferred background in Marketing, Communications, Event Management, Data Analytics, Business, or Digital Media Required / Preferred Education Level: Undergraduate rising Junior or Senior preferred Preferred Coursework: Event Marketing or Experiential Marketing Digital Marketing or Integrated Marketing Communications Marketing Analytics / Data Analysis Consumer Behavior or Brand Strategy Emerging Technologies, AI in Business, or Innovation Strategy (preferred but not required) Required / Preferred Technical Skills: Proficiency in Microsoft Excel Familiarity with data visualization tools such as PowerPoint, Canva, Tableau, or similar Basic understanding of marketing analytics and performance metrics Comfort using digital platforms and AI tools (marketing automation platforms, survey tools, or CRM systems a plus) Strong research and analytical skills with ability to translate insights into clear recommendations Additional Desired Skills: Excellent written and verbal communication Strategic thinking with creativity Interest in live events, customer experience Ability to synthesize qualitative and quantitative data into actionable insights. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $20.63-$27.85/Hourly
$20.6-27.9 hourly Auto-Apply 11d ago
Contract Administration for Sales support for North America, Internship
Haemonetics 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Job Details Internship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The Contract Administration for Sales support Internship for North America Internship will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St. The Summer 2026 Internship is a 12-week program that requires a commitment to start on June 1st and stay through August 21st. North America Contract Team supports Sales and other departments to enable contract completion and pricing administration to support AOP. Variety of experiences and duties which may include: Perform department-specific project work. Assist in preparing information and research materials; create and maintain PowerPoint presentations. Take notes and memos during meetings; type documents, drafts, and reports; sort and manage files. Manage databases and input information, data, and records. Research and gather documentation on company's position in the industry. Attend company functions and networking events. Shadow multiple office positions and train in a variety of tasks. Required Degree - Bachelor's degree Preferred Degree - Continuing Education, Grad student, Legal, Administration, Political Science, Business Required Skills - Microsoft Word, Excel Preferred Skills - Teams, Outlook, Advanced Excel, Advanced Word, Redlining Documents, Good computer skills EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $20.63-$27.85/Hourly
$20.6-27.9 hourly Auto-Apply 11d ago
Contract Administration for Sales support for North America, Internship
Haemonetics Corp 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Job Details Internship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The Contract Administration for Sales support Internship for North America Internship will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St. The Summer 2026 Internship is a 12-week program that requires a commitment to start on June 1st and stay through August 21st. North America Contract Team supports Sales and other departments to enable contract completion and pricing administration to support AOP. * Variety of experiences and duties which may include: * Perform department-specific project work. * Assist in preparing information and research materials; create and maintain PowerPoint presentations. * Take notes and memos during meetings; type documents, drafts, and reports; sort and manage files. * Manage databases and input information, data, and records. * Research and gather documentation on company's position in the industry. * Attend company functions and networking events. * Shadow multiple office positions and train in a variety of tasks. Required Degree - Bachelor's degree Preferred Degree - Continuing Education, Grad student, Legal, Administration, Political Science, Business Required Skills - Microsoft Word, Excel Preferred Skills - Teams, Outlook, Advanced Excel, Advanced Word, Redlining Documents, Good computer skills EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $20.63-$27.85/Hourly
$20.6-27.9 hourly Auto-Apply 11d ago
Principal Product Development Engineer (Hybrid, Boston)
Haemonetics Corp 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details We are seeking a highly skilled and innovative Principal Product Development Engineer to join a team of scientists and engineers located in our Boston, MA Research and Development Systems Engineering Laboratory contributing to the design and development of an in vitro diagnostic (IVD) device. This role involves applying advanced scientific principles and creating reliable, accurate, and regulatory-compliant clinical diagnostic solutions in whole blood hemostasis testing. The focus of this position will be to evaluate and develop novel assay designs to drive innovative solutions to complex issues. This individual will be both a leader and collaborator within the multidisciplinary development project team to ensure timely and proficient completion of projects in a fast-paced and evolving environment. The ideal candidate will have a strong background in bioengineering, biochemistry, analytical chemistry, or similar fields combined with experience in assay development and device integration. This role is Hybrid onsite in our 125 Summer Street NA HQ with substantial bench-level and laboratory activity. Key Responsibilities: * Design and Development * Contribute to the development of IVD assays and devices from concept through commercialization. * Work independently and apply advanced scientific principles and methods in experimental design and data interpretation. * Optimize assays for sensitivity, specificity, reproducibility, and design for manufacture * Collaborate with engineering teams to integrate assays into device platforms. * Verification and Validation Testing * Develop and execute verification and validation protocols in compliance with applicable regulations. * Perform analytical performance studies to ensure product requirements are met. * Work with the clinical science team to write clinical trial protocols and reports. * Laboratory Management * Apply good laboratory practice principles to ensure R&D laboratories are well-maintained. * Contribute to the management of the laboratories including tracking calibrations, environmental monitoring, safety hazards, and other tasks, as required. * Cross-Functional Collaboration * Work closely with hardware/software engineers, regulatory affairs, quality assurance, basic science/service lab, scientific affairs, marketing, and manufacturing teams. * Provide scientific expertise during design reviews and risk assessments. * Assist the manufacturing team in solving production issues and sustaining projects through technical expertise and investigational bench testing. * Exhibit highly effective communication and collaboration skills that can be applied across functions. * Documentation and Compliance * Ensure adherence to quality management systems and regulatory standards. * Establish, train, and maintain an easy-to-use laboratory testing documentation procedure for Boston based investigational testing. Qualifications: * Ph.D. or M.S. in Bioengineering, Biochemistry, Analytical Chemistry, or related field required. * Minimum 2-4 years in IVD development or related industry. * Proven track record in proven track record in assay design & development including design optimization, device integration, verification, and transfer to production activities * Experience developing and optimizing assays on disposable microfluidic or cartridge-based platforms. * Experience in reagent formulation and stabilization for microfluidic applications (small-volume drying, bead-based reagents, in-channel drying, long-term stability on plastic substrates). * Familiar with disposable microfluidic design and fabrication methods (injection molding, film lamination, laser cutting/welding, reagent deposition, adhesive/ultrasonic bonding, QC methods). * Prior success supporting 510(k), PMA, or technical file submissions. * Preferred Experience * Hands-on experience with developing assays or diagnostic platforms. * Experience with data analysis software and statistical tools. * DOE (multifactor, multivariate experimental design and modeling) * Skills: * Strong knowledge of biochemical, reagent-driven, clinical diagnostics. * Familiarity with regulatory requirements (FDA, CLSI, IVDR, ISO standards). * Excellent problem-solving, project management, and communication skills. * Comfortable engaging with outside equipment, material, and chemical/reagent manufacturers. As well as other researchers, and engineering/scientific testing service providers. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $101,074.94-$136,586.75/Annual
$101.1k-136.6k yearly Auto-Apply 20d ago
Summer 2026 Internship: Industrial Biotechnology Intern - Lexington, MA
DSM 4.3
Lexington, MA job
Summer 2026 Internship: Industrial Biotechnology Intern If you're looking to grow your network and gain new skills within a global company, an internship with dsm-firmenich could be the program for you. Our summer internships provide students opportunities to work on real business projects and gain invaluable professional experience. As an intern, you'll have exposure to many different areas of a global flavors, fragrances, and ingredients organization that works with some of the biggest brands in the world, along with opportunities to network with your peers and leadership. From engaging events to mentoring opportunities and valuable resume-building experiences, we're committed to preparing you for a fulfilling and enduring career, both at dsm-firmenich and beyond. We are currently looking for an Industrial Biotechnology Intern at our Lexington, MA office. The 2026 dsm-firmenich Summer Internship Program will run from June 1, 2026 to August 14, 2026. Working Hours: Monday - Friday, 37.5/40 hours per week Join our Biotechnology Science and Research team as an intern and gain invaluable professional experience. Enhance your skills and contribute to real projects that have visibility across the business through a Summer internship. Come discover all we have to offer! Your key responsibilities * Plan and conduct early-stage industrial biotechnology research for products in the health, nutrition, and beauty space * Leverage synthetic biology to design, build, and test genetically modified organisms for the fermentative production of various high-value compounds * Collaborate with a multi-disciplinary team of scientists (both local and global) to deliver scientific solutions for key projects * Collect, analyse, and communicate experimental data to help inform decision-making and project direction We bring * Build Your Future Skills: Gain hands-on experience and develop practical skills that prepare you for a successful career. * Expand Your Network: Connect with professionals and peers in a company where sustainability drives every decision and action. * Thrive in an Inclusive Culture: Join a community that values and respects every individual-regardless of background, beliefs, or identity. * Grow Through Curiosity: Work in an environment that encourages open-mindedness, learning, and collaboration to create a better future together. You Bring * Currently working on completion of a Bachelors or Graduate degree in a Biology, Chemical Engineering, Biotechnology or Life Sciences related field * Must be available to work full-time on-site beginning on June 1, 2026 to August 14, 2026. * Previous molecular and/or microbiology laboratory experience preferred * Organizational, problem-solving, and analytical skills; able to manage priorities and workflow The hourly rate for this position is $23.00 - $26.00 per hour. Compensation will be dependent on factors that include location, education, training, specific skills, and years of experience. At the end of this internship, you will: * Have developed technical skills in the microbiology and molecular biology space * Expanded your professional network * Gained experience in industry projects, strategy, and corporate structure About dsm-firmenich: At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. Inclusion, belonging and equal opportunity statement: At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement: We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
$23-26 hourly 3d ago
Internship - Systems Verification & Validation Engineering
Haemonetics 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Imternship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The Systems Verification & Validation Engineering Intern will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St. The Summer 2026 Internship is a 12-week program that requires a commitment to start on June 1st and stay through August 21st. What You Will Do this Summer: The intern will be working within the Systems Verification & Validation Engineering Team. This team is responsible for the overall verification, and validation of the medical device system. We act as the technical nexus, ensuring that the hardware, software, and mechanical components function together reliably and meet stringent regulatory and performance requirements. The team owns a Hardware-in-the-Loop (HIL) testbed, which is a crucial tool for continuous, automated, and non-intrusive testing of medical systems, specifically for regulated medical industry. This project involves the development and implementation of key components for the existing Hardware-in-the-Loop (HIL) testing infrastructure used for verifying the medical device system. The intern will gain hands-on experience with systems integration, test automation, and verification and validation processes essential for a regulated environment. The project can be broken down into the following areas: Test Script Creation & Automation: Develop robust, reusable test scripts (using languages like Python) that execute specific test cases against the live medical device hardware via the HIL testbed. This involves understanding the system's operational modes and failure conditions. Test Tool Framework Development: Build upon or extend the existing test tool framework used to interface with the hardware under test. This may involve creating new API wrappers or improving the libraries that manage communication and control (e.g., sending commands, reading telemetry) between the host PC and the embedded medical device. This ensures a standardized and stable foundation for test execution. Data Logging and Reporting: Implement or enhance the system for automated collection of test data (e.g., device logs, simulator output, pass/fail status). Develop tools or scripts to process this data and generate clear, structured reports suitable for engineering review and formal verification documentation. Who You Are: Rising Junior/Senior or grad student: currently pursuing a Bachelor's or Master's degree in Biomedical Engineering, Software Engineering, Computer Science, or a related engineering field. Preferred Coursework/Technical Skills: Experience with scripting languages like Python, Java, Perl, Ruby etc., an understanding of networks or networking, understanding of how to work with electrical and mechanical components in a system. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $20.63-$27.85/Hourly
$20.6-27.9 hourly Auto-Apply 3d ago
Internship - Clinical Affairs AI
Haemonetics 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Internship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The Clinical Affairs AI intern will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St. The Summer 2026 Internship is a 12-week program that requires a commitment to start on June 1st and stay through August 21st. What You Will Do this Summer: This internship provides hands-on experience at the intersection of clinical research operations and applied generative AI. The intern will contribute to developing standardized, AI-assisted templates and workflows for key clinical trial documents-including Protocols, Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs). This role is ideal for someone interested in clinical development, documentation excellence, and the practical use of AI to improve efficiency and quality. Key Responsibilities Design, test, and refine AI prompts that support consistent, high-quality drafting of common clinical documents. Collaborate with subject matter experts to identify required document elements, regulatory expectations, and style/formatting standards. Build prototype templates and prompt frameworks for Protocols, ICFs, and CSRs that can be used across studies and teams. Evaluate AI-generated outputs for accuracy, clarity, and compliance with clinical and regulatory guidelines. Document recommended best practices for AI-assisted writing within clinical research workflows. Provide feedback on opportunities to scale or automate portions of the documentation lifecycle. Project Goals Develop standardized AI-prompting playbooks for key clinical documents (Protocol, ICF, CSR), ensuring reproducible structure and content quality. Create a library of reusable prompt templates that guide AI systems to produce consistent, audit-ready document sections. Establish evaluation criteria for assessing AI-generated text for compliance, clarity, and alignment with organizational standards. Produce sample AI-assisted document drafts to demonstrate the effectiveness of refined prompting strategies. Recommend process improvements for integrating AI tools into clinical documentation workflows. Learning Outcomes By the end of the internship, the intern will gain experience with: Advanced prompt engineering techniques AI-supported medical/clinical and regulatory writing Clinical trial documentation structure and requirements Workflow development within regulated environments Cross-functional collaboration with clinical, regulatory, and scientific affairs teams Who You Are: Currently pursuing or recently completed a degree in Life Sciences, Public Health, Data Science, Data Analytics, Technical Writing, or a related field. (undergraduate senior or graduate student) Strong interest in clinical research, regulatory documentation, or applied AI tools. Familiarity with basic principles of clinical trials and common document types (e.g., Protocol, ICF, CSR) is a plus. Experience using generative AI platforms (e.g., ChatGPT, Claude, Gemini) for writing, summarization, or information analysis. Strong written communication skills and attention to detail, especially when reviewing technical or scientific content. Ability to learn quickly, troubleshoot AI outputs, and refine prompts through structured experimentation. Comfortable working with templates, style guides, and structured document frameworks. Analytical mindset with the ability to compare AI outputs against standards and identify gaps. Ability to work independently, manage multiple small tasks, and synthesize feedback into improved workflows. Proficiency with MS Word, Google Docs, or other document-editing tools; familiarity with version control practices. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $20.63-$27.85/Hourly
$20.6-27.9 hourly Auto-Apply 3d ago
Summer 2026 Internship: Microbiome Sciences Intern, Science and Research - Lexington, MA
DSM 4.3
Lexington, MA job
Summer 2026 Internship: Microbiome Sciences Intern, Science and Research If you're looking to grow your network and gain new skills within a global company, an internship with dsm-firmenich could be the program for you. Our summer internships provide students opportunities to work on real business projects and gain invaluable professional experience. As an intern, you'll have exposure to many different areas of a global flavors, fragrances, and ingredients organization that works with some of the biggest brands in the world, along with opportunities to network with your peers and leadership. From engaging events to mentoring opportunities and valuable resume-building experiences, we're committed to preparing you for a fulfilling and enduring career, both at dsm-firmenich and beyond. We are currently looking for a Microbiome Sciences Intern at our Lexington, MA office. The 2026 dsm-firmenich Summer Internship Program will run from June 1, 2026 to August 14, 2026. Working Hours: Monday - Friday 8:00am-5:00pm Join our Microbiome Science and Research team as an intern and gain invaluable professional experience. Enhance your skills and contribute to real projects that have visibility across the business through a Summer internship. Come discover all we have to offer! Your key responsibilities * Plan and conduct early-stage Microbiome research for products in the health, nutrition, and beauty space * Assist in the design, execution, and analysis of microbiology-related experiments using different in vitro and ex vivo systems * Assist in building microbial tools (e.g. strain libraries) * Collect, analyse, and communicate experimental data to help inform decision-making and project direction We bring * Build Your Future Skills: Gain hands-on experience and develop practical skills that prepare you for a successful career. * Expand Your Network: Connect with professionals and peers in a company where sustainability drives every decision and action. * Thrive in an Inclusive Culture: Join a community that values and respects every individual-regardless of background, beliefs, or identity. * Grow Through Curiosity: Work in an environment that encourages open-mindedness, learning, and collaboration to create a better future together. You bring * Currently working on completion of a degree in Biology or a Life Sciences related field * Candidates must be available to work full-time beginning June 1, 2026 - August 14, 2026 * Previous molecular and/or microbiology laboratory experience preferred * Experience in microbial isolation, microbial culture maintenance, and nucleic acid extraction preferred * Organizational, problem-solving, and analytical skills; able to manage priorities and workflow The hourly rate for this position is $23.00 - $26.00 per hour. Compensation will be dependent on factors that include location, education, training, specific skills, and years of experience. At the end of this internship, you will: * Have developed technical skills in the microbiology and molecular biology space * Expanded your professional network * Gained experience in industry projects, strategy, and corporate structure About dsm-firmenich: At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. Inclusion, belonging and equal opportunity statement: At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement: We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
$23-26 hourly 3d ago
Internship - Corporate Accounting and SEC Reporting
Haemonetics Corp 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Internship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The Corporate Accounting and SEC Internship will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St. The Summer 2026 Internship is a 12-week program that requires a commitment to start on June 1st and stay through August 21st. The Corporate Accounting and SEC Reporting team oversees accounts payable, corporate accounting and SEC Reporting. I think there will be ample ability to get the intern exposure to all 3 and support our monthly/quarterly close. What You Will Do this Summer: * Copying numbers into workiva from Excel * Checking formatting of 10Q in Workiva * Performing research against peers 10Qs * Audit board clean-up * Policy Updates Who You Are: * Education: B.S. or M.S. in Accounting or Finance - Required * Technical Skills: Excel (Pivots, Vlookups) - Required * Preferred Software Skills: Workiva, Quickbase, Concur * Other Skills: attention to details, time management and organizational skills EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $20.63-$27.85/Hourly
$20.6-27.9 hourly Auto-Apply 14d ago
Internship - Treasury & Risk Management/Investor Relations
Haemonetics 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Internship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The Treasury & Risk Management/Investor Relations Internship will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St. The Summer 2026 Internship is a 12-week program that requires a commitment to start on June 1st and stay through August 21st. This 2026 internship will expose the individual to key functions of the finance organization with specific focus on day-to-day activities and deliverables for the Treasury and Investor Relations departments. This role is an opportunity to expand your knowledge of the Medtech industry while gaining an understanding of Haemonetics' corporate operations. The main objective of the internship is to provide insight into two distinct yet interconnected finance fields to gain an appreciation for the role each plays within the scope of the broader organization. What you will do this Summer: Treasury: • Monthly updates and maintenance to treasury schedules including debt and interest swaps. • Support cash forecasting via compilation and assessment of global transaction data • Perform analysis of recent US and global bank charges for various transactions in addition to cleanup of users, reduction of duplicative processes, and further process automation. • Support team with inquiries related to insurance, payments, accounting, accounts payable and accounts receivable • Gain practical insights into our hedging strategies and discover how Treasury helps manage foreign currency volatility to support the business. Investor Relations: • Assist with producing materials for the company's quarterly earnings call. • Utilize industry tools and software and manage the IR CRM. • Work with the website team to provide updates to the IR website. • Summarize company, competitor, and market trends in news and analyst reports for distribution to executive management. • Support investor interactions, including researching and preparing responses to investor inquiries. Who You Are: Degree Type: Finance, Accounting, or similar - required Required Education Level: Undergrad rising Senior or higher Coursework Required: Finance, Investments, Accounting, or similar Technical Skills: MS Office Suite (Outlook, Word, PowerPoint, etc.), Proficient in Excel functions, strong business communication, strong organization skills. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $20.63-$27.85/Hourly
$20.6-27.9 hourly Auto-Apply 18d ago
Internship - Blood Laboratory and Scientific Service
Haemonetics 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Internship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The Blood Laboratory and Scientific Intern will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St. The Summer 2026 Internship is a 12-week program that requires a commitment to start on June 1st and stay through August 21st. What You Will Do this Summer: The intern will work in the R&D blood laboratory in Boston. Blood lab is the only lab at Haemonetics with resources to support any projects/products (TEG, cell saver, plasma) that requires blood testing. The Scientific Service is a remote team that supports all activities related to biocompatibility and sterilization for all our products. For the blood lab projects, the intern will learn appropriate laboratory techniques and procedures to work with blood samples and multiple laboratory equipment, including a hematology analyzer, TEG devices, and a flow cytometer. For the blood lab project, the intern will learn techniques to work with blood samples and to operate a clinical hematology analyzer and TEG analyzers. This project relates to the optimization of our Platelet Mapping Cartridge. The intern will work under the supervision of a PhD level scientist, and depending on the project's timeline, would be able to either complete the project or help progressing it. The project under the Scientific Services team will encompass both biocompatibility and sterilization. The intern will learn about biocompatibility and sterilization in the medical device field, including but not limited to regulations, standards, and testing requirements. Who You Are: Rising junior with a BS in life science, ie biochemistry, biology, molecular biology, chemistry. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $20.63-$27.85/Hourly
$20.6-27.9 hourly Auto-Apply 3d ago
Global Internal Audit Internship - ACE (Audit Committee, Corporate Controls Oversight Team, & Executive) Data Visibility Dashboards Internship
Haemonetics 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Internship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The internship will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St. The Summer 2026 Internship is a 12-week program that requires a commitment to start on June 1st and stay through August 21st. Haemonetics Global Internal Audit (GIA) is currently seeking a highly motivated intern with strong analytical and interpersonal skills. The intern will be an integral member of the GIA team and work closely with our GIA Senior Managers and Analyst on projects focused on evolving our Audit & Risk Data Visibility reporting. Specifically, the intern will reshape multiple key Audit Trend dashboards to enhance risk and root cause visibility for Audit Committee & Sr. Leadership to aid in their risk oversight responsibilities. Furthermore, this effort will support GIA's continuous improvement to ensure alignment with the Institute Of Internal Auditors Professional Standards. The intern will support GIA's vision and mission: help the business achieve its objectives by bringing a systematic, disciplined approach to evaluate and enhance the effectiveness of risk management, controls and governance processes. For summer 2026, the GIA intern projects will optimize GIA's ACE (Audit Committee, Corporate Controls Oversight Team, & Executive) Data Visibility Dashboards for streamlined reporting & mitigation process in AuditBoard's OpsAudit and RiskOversight modules. Interns will: Collaborate with GIA members on ACE Data Visibility Dashboards migration & transformation within AuditBoard to enhance real time risk monitoring Collaborate with GIA members on automating & optimizing the reporting process Identify opportunities to cleanse & optimize findings and MAP data Synthesize data insights for audit & executive reporting Present results to key stakeholders The GRC & analytics dashboards developed by the intern will facilitate tracking, reporting, trending, & risk insight development, while driving continuous process improvement across multiple functions. Required/Preferred Education level: Grad student & Senior Required/Preferred Degree type: Accounting, Finance, Data Analytics Preferred Coursework: Audit and Assurance, Finance, Financial Reporting, Accounting, Data Analysis Preferred Technical Skills: AuditBoard, Tableau, Power BI, Sigma, R, Python, Data Analysis and visualization EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $20.63-$27.85/Hourly
$20.6-27.9 hourly Auto-Apply 11d ago
Business Process and Systems Project Coordinator - (Boston Based)
Haemonetics 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Supports the planning, coordination, execution, and delivery of projects ranging from enterprise initiatives to functional continuous improvement efforts. Key responsibilities include driving project governance, documentation, reporting, resource planning, and ensuring projects follow organizational standards and frameworks. This individual will be highly organized, accel at stakeholder communication and manage the timely delivery of project milestones with a collaborative, firm demeanor. The coordinator works closely with project managers, functional/technical consultants, business stakeholders, and external partners. Responsibilities Project Coordination and Support Coordinate projects involving business process improvement, system enhancements, and cross-functional workflow alignment. Develop and maintain project plans, timelines, schedules, and task lists. Track project milestones, deliverables, risks, issues, and dependencies. Facilitate multiple projects, deadlines, and stakeholders simultaneously. Coordinate project meetings, prepare agendas, record minutes, and follow up on action items. Drive collaborative adherence to plans while constructively supporting areas of delay and escalating areas of risk. Stakeholder Communication Serve as a central communication point between IT, business users, system integrators, and executive stakeholders. Prepare project status reports, dashboards, and weekly updates. Ensure cross-functional collaboration and integrated planning between business, technical and 3rd party teams. Documentation and Reporting Maintain project documentation, test scripts + results, training materials, and cutover plans. Assist with creation and maintenance of project governance documents (RAIDs logs, communication plans, implementation checklists). Ensure compliance with PMO standards, SDLC, and quality control processes. Prepare performance dashboards, project reports, and process documentation. Cross-functional Leadership Synthesize inputs and reporting to drive meaningful, succinct updates / action plans. Apply analytical skills to ensure clarity and efficiency in project work (at the management and team level). Take & Drive accountability on work assignments. Continuously improve Haemonetics project leadership, deliverables and management processes. Coach / Mentor new project participants on best practices to drive efficient results. Maintain situational awareness to present the right information at the right level across project teams to executives. Qualifications Bachelor's degree in Business Administration, Operations, Engineering, or related field required 5+ years' experience in project coordination, PMO support, business analysis, system support or process improvement roles preferred 5+ years' experience with ERP systems (e.g., SAP, Oracle, SalesForce, Agile, Workday) preferred PMP, CAPM, Lean Six Sigma Yellow/Green Belt, Business Analysis (ECBA), or similar certification preferred Skills Strong knowledge of project management methodologies (Waterfall, Agile, hybrid). Proficiency with PMO tools: MS Project, Power BI, Confluence, Jira, Sharepoint or similar. Process mapping skills (Visio, Lucidchart, Miro) Excellent coordination, communication, and organizational skills. Change management and continuous improvement mindset. Knowledge of business systems (ERP, CRM, workflow tools) Ability to collaborate across teams and influence without authority. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $76,434.43-$103,290.88/Annual
$76.4k-103.3k yearly Auto-Apply 31d ago
Manager, R&D Applications
Sumitomo Pharma 4.6
Sumitomo Pharma job in Marlborough, MA
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, Clinical Systems R&D IT Business Applications who will serve as the primary liaison between R&D Clinical Operations team and IT, responsible for the delivery and support of technology solutions that align with business needs and operational demands. This role requires proficiency in implementing, integration, and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment Job Duties and Responsibilities Partner with Clinical business stakeholders to co-create technology plans which support their business objectives and operational demands Continuously assess current systems environment and identify changes (process and/or system) that enhance effectiveness Assist in the evaluation of new technology systems and/or service providers Oversee end-to-end management of IT projects-including planning, design, and implementation-ensuring projects are delivered on time, within scope, and with measurable business impact Work with a team of managed service providers supporting the lines of business technology needs including project delivery, solution design, enhancement requests and support services Accountable for managing clinical application systems through their full lifecycle, from implementation to ongoing optimization Lead and initiate troubleshooting quality and/or functionality issues associated with technology systems in scope Develop and maintain comprehensive project documentation, ensuring centralized storage and accessibility for knowledge management Manage and prioritize system enhancements and fixes in collaboration with business stakeholders Provide regular project status reports, manage issues proactively, and adjust schedules as needed while maintaining alignment with the overall program plan Responsible for timely execution of all GxP system commitments and compliance activities (Backup recovery, Disaster Recovery testing etc.) Collaborate with cross-functional IT teams to ensure seamless delivery of services, efficient communication, and shared accountability for outcomes Establish clear performance metrics and service level agreements (SLAs) to monitor IT service delivery, project outcomes, and stakeholder satisfaction Stay informed of emerging industry trends, best practices, and regulatory changes to proactively recommend technologies and process adaptations that empower the company during phases of rapid expansion Serve as the IT subject matter expert for application upgrades, integrations, and system enhancements across supported business areas Key Core Competencies Strong understanding of Clinical business processes, requirements and technology systems supporting Clinical Trials (e.g. EDC, CTMS, ETMF, Payments etc.) 7+ years of progressively increasing experience managing clinical applications in a Pharma/Biotech company Strong understanding of building and operating a technology support function Proficient in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment Education and Experience BS/BA degree in a related discipline is required. Training or equivalent experience in IT or business management is beneficial but not required 7+ years of experience in life sciences with a focus on IT system delivery 5+ years of experience in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment Experience in Program & Project Management, including the Software Development Lifecycle and Computer Systems Validation process Excellent communication skills The base salary range for this role is $127,440 to $159,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
$127.4k-159.3k yearly Auto-Apply 56d ago
Trial Master File (TMF) Specialist Oncology
Sumitomo Pharma 4.6
Sumitomo Pharma job in Boston, MA
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
$72.5k-90.6k yearly 60d+ ago
Senior Design Quality Engineer
Haemonetics Corp 4.6
Boston, MA job
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details The Senior Design Quality Engineer specializing in Software design and development will work as a member of the cross-functional design team supporting new product development and sustaining engineering change management for embedded software within the TEG and Plasma systems. SUPPORT NEW PRODUCT DEVELOPMENT & PRODUCT CHANGE MANAGEMENT BY: * Represent Quality department as cross-functional team member for product portfolios, new product development projects, and product change projects * Support development team in creation, review, and approval of Software engineering Requirements & Specifications in accordance with standard operating procedures * Lead cross-functional teams in the development, update, and release of Software risk management documentation inclusive of but not limited to: Hazard Analysis, Risk Management Plan & Report, FMEA's (Use, Design & Process), Fault Tree Analysis (FTA) * Lead or support development team in creation, review, and approval of engineering development plans & test plans * Support development team in creation, review and approval of software engineering test protocols and reports in support of software verification, software validation and system validation * Support development team in creation, review, and approval of traceability of user requirements, software engineering specifications, and software verification & validation testing * Ability to support any Product Line Portfolios and actively supports 1 or more Product Line Portfolios * Ensure accuracy and completeness of the Design History File and the Device Master Record * Compile, review, and analyze failure data to provide feedback to the development team * Mentor, develop, coach, and / or supervise less experienced quality engineers * SUPPORT QUALITY SYSTEM BY: * Ensuring compliance to and enforcement of all required elements from regulations, standards, policies, standard * Supporting and administering quality system elements including but not limited to: Design Controls, CAPA, Non- Conformance, Complaint, Deviation, Document Controls, Labeling, etc. * Lead continuous improvement projects and reviews of policies, procedures, instructions, and training * Ensure the ongoing readiness for and participate in any potential internal/external audits and inspections * Lead or participate in problem solving and other work improvement activities Qualifications: * Minimum of 7 years medical device or IVD product development and design quality engineering experience * Excellent Organization skills * B.S. in Biomedical, Mechanical, Electrical or other appropriate Engineering degree. * Good working knowledge of medical device design control process including risk management and design transfer * Strong team collaboration with ability to handle multiple tasks in a fast pace new product introduction environment. * Manufacturing process validation knowledge and experience * Familiar with medical device Quality Management Systems * Travel to company sites as required. * Effective communication, presentation and collaboration skills. * Proficient with office, planning and analysis software tools. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************. The base salary range for this role is: $87,892.99-$118,774.78/Annual
$87.9k-118.8k yearly Auto-Apply 39d ago
Scientist II
Sumitomo Pharma 4.6
Sumitomo Pharma job in Boston, MA
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist II. This position will be part of the Translational Research and Medicine-Oncology team, with a primary focus on advancing translational research to support oncology programs in clinical trial stages. This individual will be responsible for designing, oversighting, and interpretating translational studies to understand mechanism of action, resistance pathways, and potential new indications. The candidate may also be involved in biomarker analysis to support these translational objectives. **Job Duties and Responsibilities** + Develop hypotheses by integrating insights from scientific literature, preclinical and clinical data + Design experiments to support identification of mechanism of action, resistance mechanisms, and potential indications + Manage translational research and biomarker studies conducted with CROs and academic investigators to ensure high-quality, timely delivery of data + Maintain organized, detailed logs of studies and data to ensure accuracy, reproducibility, and compliance with regulatory standards + Present data and insights in internal meetings and cross-functional program team discussions **Key Core Competencies** + Scientific curiosity with ability to generate and test hypotheses that inform drug development + Excellent problem-solving and critical-thinking skills to interpret complex data + Strong organizational skills and attention to detail in managing studies, data, and documentation + Strong project management and vendor oversight skills + Adaptability and resilience in a fast-paced, evolving research environment **Education and Experience** + PhD degree in a related field of science (Biology, Biochemistry, Molecular & Cellular biology, Cancer Biology, Immunology) + 1-3 years of postdoctoral or industry research experience + Familiarity with oncology research preferred + Experience with common biomarker platforms (e.g. NGS, flow cytometry, IHC) preferred The base salary range for this role is $102,000 to $127,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
$102k-127k yearly 60d+ ago
Associate Director, Marketing Analytics - OAB
Sumitomo Pharma 4.6
Sumitomo Pharma job in Marlborough, MA
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Job Overview The Associate Director, Marketing Analytics - OAB position will lead business insights for the commercial organization as it relates to the Overactive Bladder therapeutic area. This role will be required to operate with diverse data sources, vendors, stakeholders, in a rapidly changing business environment. This position will report to the Director, Commercial Analytics - OAB and will be an integral part of the Commercial Analytics team. This position will partner with marketing, finance, and market access leadership, along with other Commercial Analytics leaders to deliver accurate, timely, and reliable insights to stakeholders across the commercial organization. Job Duties and Responsibilities Perform a critical role in enhancing marketing offerings by developing integrated insights from data/information to shape commercial strategy and decisions. Partnering with key stakeholders, create and execute annual market research and analytics plans that align to brand strategy and performance measurement needs. Conduct advanced analytics for brand teams to inform brand planning, promotional resource allocation, and marketing strategies, including patient journey creation and ROI analysis. As part of the Gemtesa brand planning process, support the development brand-specific situational analysis, participate in tactical planning, and partner with sales and marketing to create meaningful KPIs. Closely involved with financial planning process, providing key insights and assumptions for annual and long-range plan forecasting in partnership with brand leadership. Develop compelling and actionable insights presentations for key stakeholders, including brand leadership, cross-functional partners, and senior management while adapting communication style based on audience. Lead the development of deep dive analytical suite assimilating insights from multiple sources, both internal and external, to help provide a thorough understanding of brand performance. Develop strategic partnership as the point of contact for Gemtesa brand team. Develop and prioritize key business questions with the cross-functional support of medical, clinical, brand teams, and other partners in the organization. Manage development anddelivery of strategic KPIs and supporting metrics for the monthly and quarterly business reviews. Direct analytic ad hoc project requests related to the Gemtesa brand team. Key Core Competencies Strategic thinker: can see big picture opportunities and translate into actionable plans. Excellent written and oral communications skills including executive presence in formal stakeholder presentations. Strong knowledge and experience with pharmaceutical data sources (i.e., IQVIA, SHA, MMIT/DRG formulary / market access data). Strong knowledge and experience with patient and HCP market research and translating insights from research into actionable recommendations. Strong understanding of omnichannel data and media promotion measurement (e.g. Crossix, Media Agencies, etc). Proven success in developing analyses with Business Intelligence tools and methods (e.g., Tableau, Qlikview, SQL). Excellent team player and collaborative skills. Strong demonstrated project management skills and managing external vendors/ deliverables within tight timelines. Strategic partner to multiple cross-functional stakeholders. Ability to understand the commercial environment and business needs and translate to workable solutions. Highly motivated change agent that can push against the status quo and seed new ideas, new ways of thinking, and new ways of working. Education and Experience Minimum 8 - 12 (w/o Master's) or 6 - 8 years (with Master's) years of relevant experience in biotech or pharmaceutical industry. Previous marketing, marketing science, or omnichannel experience preferred. Previous commercial/ brand analytics experience (with Statistical Packages) preferred (e.g., SAS, R, SPSS, etc). Patient/consumer and HCP insights and strategy experience. The base salary range for this role is $150,640 to $188,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
$150.6k-188.3k yearly Auto-Apply 60d+ ago

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Scientist II

Associate Director, Marketing Analytics - OAB

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