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Takeda Pharmaceuticals U.S.A., Inc. jobs in Saint Paul, MN - 59 jobs

  • Executive Assistant, Lead Support

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Lexington, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: As Executive Assistant, Lead Support, you'll partner directly with the Site Head to keep site operations running smoothly and efficiently. In this high-impact role, you'll provide advanced executive and administrative support-owning complex calendars, coordinating priorities, preparing and refining materials, and ensuring clear, timely communication across the business. You'll be a trusted connector for internal and external stakeholders, helping facilitate decisions, align teams, and coordinate site-level meetings, events, and operational activities. You'll also apply sound judgment and proactive problem-solving to anticipate needs, manage sensitive information with discretion, and drive work forward independently. This role is ideal for an experienced executive support professional who thrives in a fast-paced environment, brings deep expertise across processes and systems, and is comfortable working autonomously with minimal supervision. You may also guide or mentor less experienced team members as part of supporting a high-performing site leadership team. How you will contribute: * Manage executive schedules and coordinate complex calendars for leadership and site heads * Plan and execute multi-day leadership and functional events, including senior leadership team off-sites, town halls, and employee engagement activities * Oversee logistics for visits from senior leaders and external guests, patient speaker events, volunteer initiatives, and engagements with external parties * Handle procurement tasks such as office supplies, catering, information technology equipment, and new vendor setup * Draft and distribute communications for events and announcements; maintain functional distribution lists * Support onboarding activities and quarterly welcome receptions * Manage budgets, expense reports, and invoice reconciliation for events * Serve as liaison for internal and external contacts, including Talent Acquisition and above site leadership requests * Provide backup support for communications lead * Coordinate business continuity logistics during site disruptions * Routinely seek to optimize administrative tasks with simpler digital solutions * Provide guidance to extended or external staff as needed for complex events * Facilitate clear and professional communication with internal and external contacts * Prepare and format documents with advanced skills in business software * Identify and resolve administrative challenges using creative problem-solving What you bring to Takeda: * Bachelor's degree preferred * 5+ years supporting senior executives and coordinating events * Proven experience managing executive schedules with attention to detail * Strong communication skills to represent the executive office professionally with diverse contacts * Advanced proficiency in business software for document preparation and formatting * Comfort using digital and artificial intelligence-enabled tools to streamline scheduling, document drafting, and event coordination, with sound judgment on confidentiality * Commitment to maintaining confidentiality and handling sensitive information responsibly * Ability to serve as an effective intermediary to facilitate communication * Experience coordinating events and operational activities at the site level * Skilled in managing multiple priorities with strong organizational abilities * Experience in budget management and expense reconciliation * Ability to apply innovative solutions to administrative challenges More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. #GMSGQ #ZR1 #LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Lexington - BIO OPS U.S. Hourly Wage Range: $34.28 - $53.89 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Lexington - BIO OPS Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt No 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.
    $34.3-53.9 hourly 8d ago
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  • Head Global Quality Device Compliance US/ROW region

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Lexington, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role As Head of Global Quality Device Compliance for the US and Rest of World region, you will provide strategic direction and oversight for GxP medical devices, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements are established, effective, and maintained in compliance with all applicable regulatory requirements. This role partners closely with regional Device Compliance leads and cross-functional stakeholders to drive alignment and uphold Takeda's global device quality standards. You will play a key role in enabling innovation while protecting patient safety across the product lifecycle. How You Contribute * Provide strategic quality compliance direction and oversight for GxP medical devices, including stand-alone devices, combination devices, and Software as a Medical Device for the US and Rest Of World region (excluding EU, CAN, China, and Asia region). * Serve as main quality compliance person with responsibilities for Device and Combination Products to ensure that the Quality System requirements are established, effective and maintained in accordance with all applicable US and ROW region regulatory requirements. * Support oversight of compliant lifecycle management of GxP devices from R&D to discontinuation and establish a common framework and principles for Software as a Medical Device that enable safe innovation and protect patient safety. * Partner with Device Compliance heads for the EU/CAN region and for the China/Asia region on all global device activities and support execution of global compliance strategies for Takeda Device and Combination Products in alignment with the overall 1-QMS approach. * Support and execute applicable QMS processes supporting Device QMR responsibilities, including oversight of Device-related SOPs, quality councils, inspection support, and industry interactions. * Partner with critical stakeholders in Regulatory Affairs, Device Quality, and PharmSci to ensure aligned and effective quality compliance strategies. * Serve as Device Management Representative for US and Rest of World countries as needed and participate on teams developing global policies and procedures for Device and Combination Products. * Be responsible for oversight of internal and external audits and inspections, including interactions with Notified Bodies and regulatory investigators, and assure tracking and completion of corrective actions. * Attend Management Review and Quality Council for Device and Combination Products Quality Systems, assessing quality performance to demonstrate levels of control, capability, and compliance. * Engage with stakeholders to enhance and execute sustainable Device Quality support for manufacture, packaging, testing, and release, ensuring compliance with GMPs, Takeda Quality Standards, and regulatory requirements. What You Bring to Takeda * Bachelor's degree in a scientific or technical discipline (advanced degree preferred). * 7-10 years of experience in medical devices and/or combination products within a regulated healthcare environment, including 5-7 years in Quality Assurance or Compliance. * Proven leadership experience (minimum 5 years) with the ability to mentor and coach teams. * Expert knowledge of US and Rest of World regulatory requirements for Device and Combination Products. * Experience with Class I, II, and III sterile and non-sterile medical devices and related regulatory filings. * Strong analytical and risk-based decision-making skills, with the ability to address complex compliance challenges. * Demonstrated success collaborating across global, cross-functional teams and regulatory authorities. * A proactive, innovative mindset focused on continuous improvement and patient safety. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Lexington, MA U.S. Base Salary Range: $174,500.00 - $274,230.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes 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.
    $174.5k-274.2k yearly 60d+ ago
  • Sales/SR Sales Representative, Equine - MN, SD, ND

    Boehringer Ingelheim Group 4.6company rating

    Minneapolis, MN job

    Compensation Data Compensation: This position offers a base salary typically between $65,000 and $106,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Description Performs responsibilities in generating sales, market share and profitability results for assigned territory with appropriate direction. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Territory includes: MN, SD, ND, some IA Up to 80% travel Duties & Responsibilities Meets sales objectives and supports attainment of district and regional/ business unit performance objectives. Development of market, customer, and industry knowledge along with further development of technical product knowledge is imperative. Effective utilization and management of internal and external resources is expected. Perform customer/consumer training meetings and support convention and professional association business building opportunities. Maintains and utilizes expert product knowledge and highly effective selling skills in order to influence customers to support the use of BIAH promoted products. Executes brand strategies to ensure a consistent company sales and marketing message. Uses appropriate BIAH Sales Training techniques to facilitate the sale. Utilizes CRM tools to create pre-call plans. Keeps current territory records concerning activities; communicates timely, accurately and meaningfully with Management. Utilizes CRM tool and supporting analysis to plan activity, report, monitor samples and maintain customer records. Analyzes territory information to optimize customer calls and create annual business plan for execution. Monitors market conditions for changes that impact our business. Completes objectives including achieving sales plan while operating within specified expense budget. Successfully completes all sales training requirements. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation within the animal health community and internally. Requirements Sales Representative Req.: Bachelor's degree from an accredited institution preferred. Minimum of two to five (2-5) years of relevant field sales experience in a competitive selling environment or relevant industry experience required Animal health or related industry experience preferred Ability to work with general supervision General knowledge of industry practices , techniques and standards Experience presenting to various size audiences PC skills and the ability to use mobile applications Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Senior Sales Representative Req.: Bachelor's degree from an accredited institution preferred. Minimum of five-plus (5+) years of relevant field sales experience in a competitive selling environment required Animal health or related industry experience preferred Ability to work with general direction Complete understanding and application of principles, concepts, practices and standards Full knowledge of industry practices Experience presenting to various size audiences PC skills and the ability to use mobile applications Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Lead Sales Representative Req.: Bachelor's degree from an accredited institution preferred. Minimum of ten-plus (10+) years of relevant field sales experience in a competitive selling environment with a minimum of five-plus (5+) years in animal health required Ability to work without appreciable direction. Contributes to the development of new concepts, techniques and standards Considered in expert in the field Experience presenting to various size audiences PC skills and the ability to use mobile applications Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Eligibility Requirements Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older
    $65k-106k yearly 60d+ ago
  • Manufacturing Associate I - Day Shift

    Takeda 4.7company rating

    Takeda job in Brooklyn Park, MN

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: As a Manufacturing Associate I, you will perform and document daily manufacturing operations according to SOPs in a cGMP environment. You will operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels) and will execute validation protocols. You will report to the Manufacturing Supervisor. This is a day shift role with a rotating schedule. The working hours are from 5:45 AM to 6:15 PM. How you will contribute: Perform dispensing, labeling, and transferring/staging of raw materials and parts. Will assemble/disassemble, clean, and sterilize components, parts, and equipment. Maintain equipment, area, and cleaning logbooks. With general management or guidance will assemble and operate biologics production equipment, such a bioreactors, filtration units, chromatography systems and fixed/portable vessels. Perform basic trouble shooting. Document cGMP data for processing steps and equipment activities while following standard operating procedures. Main documentation includes batch records, work orders, and equipment logbooks. With general management performs/or assists with processing steps and manufacturing support activities by managing process parameters in batch record and control systems. Execute batch records and validation protocols under management/direction of others. Review equipment use logs with support. Perform inventory transactions in SAP. Performs data entry into LIMS. Perform cleaning/sanitizing production equipment. What you bring to Takeda: High school diploma or GED. Experience in GMP environment preferred. Associates degree or higher in a scientific discipline preferred. Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred. Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus. Prior experience with lab equipment a plus. Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding. Can perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT). Familiar or experience with cGMP within Biotech or Pharmaceutical operations a plus. Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily. Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and/or materials. Climb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute durations. Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute durations. Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durations. Moving Head and Neck - Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a time. Twisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a time. Repetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time. Must have the ability to work assigned shift (day or night). Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection. On rare occasions, travel may be required to offsite meetings or training event. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. #GMSGQ #ZR1 #LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Brooklyn Park, MN U.S. Hourly Wage Range: $18.85 - $29.62 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBrooklyn Park, MNWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No
    $18.9-29.6 hourly Auto-Apply 60d+ ago
  • 2026 Summer Internship Program: Data Scientist for RandD Quality Intern

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Lexington, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Objectives/Purpose: * Assist in the implementation and management of AI and GenAI data products in alignment with R&D and enterprise stakeholders. * Ensure compliance with company and regulatory requirements. * Provide support in machine learning projects for complex and large-scale data analysis. * Learn and contribute to machine learning frameworks in digital and innovation projects. Accountabilities: * Support the development and implementation of data models and algorithms for pharmaceutical quality and R&D. * Assist in leveraging generative AI and large language models to enhance data analysis and automate processes. * Collaborate with cross-functional teams to ensure data integrity and accuracy. * Provide support in designing and delivering digital projects. * Learn and help maintain GxP standards in alignment with Takeda Software Development Lifecycle policies. * Prepare and present detailed reports and visualizations to stakeholders. * Assist in the integration and advancement of AI technologies in R&D Quality. * Support the development and implementation of strategic AI initiatives to enhance Quality Management Systems (QMS). * Assist in overseeing AI-driven projects and ensure timely delivery. * Foster a culture of innovation and collaboration. Dimensions and Aspects: * Technical/Functional Expertise: Basic knowledge of AI technologies in the pharmaceutical industry, experience with machine learning models, Agile methodologies, and GxPs. * Leadership: Willingness to learn, strong relationship-building skills, and effective communication. * Decision-making and Autonomy: Provide input to decisions and ensure swift implementation. * Interaction: Experience working in teams and willingness to work in a global environment. * Innovation: Support new ways of thinking and contribute to change. * Complexity: High multicultural sensitivity and ability to navigate complex global ecosystems. Education, Behavioral Competencies, and Skills: * Pursuing a Bachelor's degree in Data Science, Statistics, Computational Biology, Bioinformatics, Computer Science, or a related field. * Some experience or internships applying machine learning/deep learning in life sciences. * Interest in AI-driven projects in a pharmaceutical or biotechnology setting. * Familiarity with generative AI and large language models. * Basic understanding of GxPs, regulatory requirements, and quality standards in the pharmaceutical industry. * Strong problem-solving skills and attention to details. * Excellent communication skills to convey complex information to non-technical stakeholders. Internship Eligibility * Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship * Must be currently enrolled in a degree program graduating December 2026 or later * The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) * The intern must be able to commit to one of these time frames * Able to work full time 40 hours a week during internship dates * Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: * Hands-on experience with real projects and responsibilities * Dedicated mentorship program pairing interns with experienced professionals * Networking opportunities with industry professionals and fellow interns * Internship events focused on professional and skills development * Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Lexington, MA U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: * Paid sick time * Civic Duty paid time off * Participation at company volunteer events * Participation at company sponsored special events * Access to on-site fitness center (where available) * Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Lexington, MA Worker Type Employee Worker Sub-Type Paid Intern (Fixed Term) (Trainee) Time Type Full time Job Exempt No 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.
    $21-46 hourly 38d ago
  • Head of Medical Device and SaMD Quality

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Lexington, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE * Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. * Lead and develop a global organization, fostering talent, accountability, and high performance to advance quality, ensure regulatory readiness, and drive innovation and operational excellence and execute Takeda's global Quality strategy for medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, geographies, and therapeutic modalities spanning Takeda's development pipeline and lifecycle management of marketed products. Drive inspection-ready and scalable, compliant, and patient-centric solutions across Takeda's R&D and commercial portfolio across the entire product lifecycle. SCOPE Leadership/People: No. of direct reports: 7-10 No. of indirect reports: 25-30 Geographic Scope: Global ACCOUNTABILITIES * Lead and oversee multiple functional areas including medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality standards. * Define and lead the global Quality strategy for medical devices, combination products, SaMD, and IVDs across all business units, geographies, and therapeutic modalities-spanning Takeda's development pipeline and lifecycle management of marketed products. * Provide senior-level Quality leadership and guidance across design, development, technology transfer, commercialization, and post-market surveillance. * Ensure global compliance with applicable medical device and software regulations (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP). * Act as or designate the Device Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC), where applicable. * Lead and develop a high-performing, globally distributed team, promoting clear accountability, performance management, and talent development. * Serve as a key Quality thought partner for senior stakeholders across R&D and Commercial to shape Takeda's strategy in the combination product and digital health space. * Influence global policy development by participating in relevant industry forums and external regulatory dialogues. * Collaborate with Regulatory, Engineering, CMC, Safety, Commercial Quality, and Digital teams to support patient-centric innovation. * Champion quality system initiatives and inspection readiness efforts, including preparation and leadership during internal and external audits. * Establish and monitor performance indicators to ensure continuous improvement in device and software product quality. * Build strategies to support efficiencies and innovative solutions. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise * Demonstrated knowledge of global regulations and guidances governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP, and global quality systems. * Strong background in software development life cycle, SaMD/SiMD validation, and quality oversight. * Ability to translate and articulate appropriate strategies and activities to ensure compliance to cGMP regulations and expectations. * A comprehensive understanding of pharmaceutical development, manufacturing, testing, and related technologies. Leadership * Demonstrated ability to lead and develop global teams, establish strategic priorities, and drive execution. * Proven track record of working with executive leadership and influencing decision-making across cross-functional stakeholders. * Highly effective communicator who establishes a compelling vision and encourages open dialogue across diverse viewpoints. * Holds employees accountable to deliver on expectations while embodying Takeda's values and priorities. * Promotes growth through development opportunities, mentoring, and support for career advancement. * Acts as a role model for taking smart, compliant risks that advance innovation. Decision-making and Autonomy * Makes high-impact decisions with accountability for results and alignment with Takeda's quality, compliance, and business objectives. * Applies structured risk-based thinking to address challenges and identify sustainable solutions. * Makes risk-based decisions on quality issues and product disposition, ensuring patient safety and cGMP compliance. * Analyzes complex data and applies judgment to make timely decisions, even with limited information. * Empowers hiring and resource decisions within budget and organizational guidelines. * Has flexible and creative problem-solving skills. Interaction * Work within complex organizations and across functions, at all levels where the incumbent may not have direct authority. * Builds and maintains strong relationships with internal teams, global stakeholders, external partners, and regulatory bodies. * Leads with clarity and poise in high-pressure or ambiguous situations. * Manages long-term strategic efforts while balancing short-term operational demands. * Collaborates across Takeda's network and serves as a trusted partner in executive-level interactions. Innovation * Drives improvement through innovation, promotes digital thinking, and fosters adoption of next-gen quality capabilities. * Encourages continuous learning and experimentation within the quality organization. Complexity * Oversees a complex and diverse portfolio of products-including devices, SaMD, IVDs, and combination products-spanning multiple geographies, business units, therapeutic modalities, and evolving global regulatory landscapes. * Navigates complex stakeholder environments, competing priorities, and evolving global regulations. * Leads enterprise-level quality initiatives that address broad strategic needs. * Develops solutions to complex Quality issues which potentially impact patient safety and compliance. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS * Minimum requirements: * Advanced degree in engineering, life sciences, or related field (B.S. required; M.S./Ph.D. preferred). * Minimum 10 years of industry experience, including 5 years in medical device and/or combination product quality. * At least 5+ years of direct leadership and team management experience. * In-depth knowledge of global medical device and SaMD regulations (FDA, ISO 13485, ISO 14971, MDR/IVDR, MDSAP). * Proven experience supporting regulatory inspections and driving quality excellence in regulated environments. * Preferred requirements: * Experience working in global matrix organizations and leading cross-cultural teams. * Familiarity with emerging digital health technologies, agile development practices, and AI/ML-enabled medical devices. * Experience with both development and commercial-stage product support, including lifecycle management and sustaining engineering. #GMSGQ #ZR-1, #LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Lexington, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes 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.
    $68k-87k yearly est. 60d+ ago
  • Oncology Territory Manager, Hematology - Minneapolis

    Daiichi Sankyo 4.8company rating

    Minneapolis, MN job

    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product(s), and their approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Job Description Responsibilities * Achieves or exceeds sales objectives through promotion of product features and benefits to our key accounts: Academic Institutions, Hospitals, Infusion Centers, Hematologists, Hospitalist, Bone Marrow Transplant members, buying groups, distributors and wholesalers in assigned territory. * Builds relationships with our customer base and key opinion leaders by personally visiting them, educating and influencing physicians and healthcare providers to prescribe Daiichi Sankyo, Inc.'s promoted products. Communicates in a fair and balanced way, products' approved indications, advantages, features and benefits in both individual and group settings. * Analyzes customer needs and interests. Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. Carries out all sales and marketing programs. Maintains frequent correspondence with District Manager, co-promotion team members, CARE team members and counterparts across the district and region. * Complies with applicable laws in providing healthcare providers with accurate information concerning Daiichi Sankyo, Inc.'s products. * Participates in assigned training and completing outside reading. Keeps abreast of the products, applications, technical service, market conditions, competitive activities, advertising, and promotional trends through the reading of pertinent literature and consulting with colleagues. Attends and participates in all required meetings and training programs. * Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts. * Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. Submits complete reports, on-time, and communicates matters that are relevant to the marketplace, competition and the marketing team to the District Manager. * Notifies the Medical Affairs Pharmacovigilance immediately of any product complaints as per SOP 805.21, Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).' Responsibilities Continued Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): * Bachelor's Degree required Experience Qualifications: * 4 or More Years overall pharma or healthcare related experience required * 1 or More Years sales/marketing experience in the pharmaceutical or medical industry required * specialty, rare disease, and/or oncology experience strongly preferred * experience selling in complex environments preferred Additional Qualifications: * Must be able to travel up to 60% * Must have a valid driver's license with a driving record that meets company requirements Compensation and seniority level/title based on experience and qualifications Additional Information Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$126,000.00 - USD$189,000.00 Download Our Benefits Summary PDF
    $22k-47k yearly est. 15d ago
  • Lead Process Scientist, Drug Product (Sr. Manager)

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Brooklyn Park, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role Embedded in our Global Manufacturing Science (GMSci) team, you will provide process science and manufacturing technology leadership for drug product manufacturing across Takeda's global network. You will act as a technical SME for small molecule oral solid dosage and/or parenteral processes, supporting both new product introductions and lifecycle management of marketed products. Working in a matrix environment, you will align cross-functional stakeholders and external partners to enable robust, compliant, and scalable manufacturing. You will also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible filing content. Overall, you will help strengthen how Takeda applies process knowledge consistently across sites to improve execution and decision-making. How you will contribute * Lead and/or oversee DP technical deliverables across the product lifecycle, including: * Technology transfer to internal sites and external contract manufacturing organizations (CMOs) * Process validation planning and execution support * Process characterization and establishment of process understanding * Serve as an escalation point for complex technical investigations and issue resolution, mobilizing and coordinating rapid cross-site support when needed. * Drive manufacturing strategies for assigned key products, ensuring the approach is consistent across Takeda's internal network and CMOs and is grounded in process knowledge and science-based risk management. * Lead continuous improvement for late-phase/matured products by identifying and advancing opportunities that improve robustness, control strategy, and operational performance without compromising compliance. * Partner effectively in a matrix environment with key stakeholders, including: * Pharmaceutical Sciences counterparts (R&D) * Manufacturing site and operating unit leaders * Local Technical Services organizations * Global Quality and Regulatory CMC teams * Ensure process knowledge is captured, shared, and reused across sites and functions to strengthen Takeda's overall DP manufacturing capability and speed decision-making. What you bring to Takeda * Degree (BS, MS, and/or PhD) in Chemistry, Chemical Engineering, or a related discipline (or equivalent combination of education and experience). * At least 5 years of relevant industry experience, with experience supporting pharmaceutical development and/or manufacturing in DP-related areas (e.g., OSD and/or parenterals). * Demonstrated success as an SME and project leader in a matrix environment, influencing technical decisions across functions and sites without relying on direct authority. * Strong working knowledge of DP manufacturing technologies, validation and tech transfer principles, and practical application of industry best practices. * Experience contributing to or leading regulatory CMC readiness, including converting process understanding into clear technical narratives and defensible control strategies. * Proven ability to analyze complex problems, drive to root cause, and implement sustainable solutions with high technical rigor. * Communication and stakeholder-management skills that enable effective collaboration, conflict resolution, and alignment across internal teams and external partners. * A working style that prioritizes focus, accountability, and measurable outcomes, while actively building capability for the future. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MABEL - Lessines, Brooklyn Park, MN, CHE - Glattpark (Opfikon) - Zurich HQ, CHE - Neuchatel, IRL - Bray - Production, IRL - Dublin - Baggot Street, IRL - Grange Castle - Production, JPN - Yamaguchi - Hikari Plant, USA - CA - Thousand Oaks - Rancho Conejo Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes 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.
    $137k-215.3k yearly 37d ago
  • 2026 Summer Internship Program: Manufacturing Sciences - Downstream Intern

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Brooklyn Park, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description The Manufacturing Sciences Downstream group supports the development, transfer, and lifecycle management of purification and filtration unit operations used in biologics manufacturing. This team ensures robust downstream process performance by executing some process development, tech transfers, process validation, lifecycle management and evaluating new technologies for implementation. The downstream team designs and executes studies that will efficiently and accurately evaluate process changes or optimizations. As an intern in the Manufacturing Sciences Downstream group, you will be immersed in a dynamic, cross-functional environment that bridges technical operations, quality control, and process development. This team plays a key role in ensuring the robustness and reliability of purification and filtration unit operations used throughout the lifecycle of biologic products-from early development through commercial manufacturing. You'll be part of a collaborative group supporting process development, scale-down model generation, deviation investigations, and the evaluation and implementation of new technologies. Over the 12-week internship, you will own one or more projects and collaborate with your manager, mentor, and team members to execute them. This experience will help you build technical skills, scientific reasoning, and business acumen while contributing to the delivery of high-quality biologic therapies. How You Will Contribute: Duties may include some of the following, under the manager's and/or mentor's supervision: * Support process development and optimization for biologics manufacturing. * Assist with downstream lab activities, including documentation, data review, and performance tracking. * Participate in scale-down model generation to simulate manufacturing conditions. * Contribute to deviation investigations and root cause analyses. * Help evaluate and implement new technologies to enhance analytical capabilities and data integrity. * Collaborate cross-functionally with Quality Control, Manufacturing, and Quality teams. * Gain exposure to GMP documentation practices and regulatory expectations in a biologics setting. Internship Development Opportunities: Interns will gain exposure to: * Operating within industry guidelines for controlled scientific experiments. * Approaches to solving real-world problems in drug development. * An introduction to regulatory requirements for biologics manufacturing. * Purification and filtration techniques commonly used in biologics production. Job Requirements: * This is a full-time, on-site position (40 hours/week). * Must be pursuing a Bachelor's or Master's degree in a scientific or engineering discipline. * Prior laboratory experience required (e.g., academic lab courses, guided research). * Comfortable working in a dynamic environment where plans may evolve. * Confident in working with and interpreting scientific data. Internship Eligibility * Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship * Must be currently enrolled in a degree program graduating December 2026 or later * The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) * The intern must be able to commit to one of these time frames * Able to work full time 40 hours a week during internship dates * Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: * Hands-on experience with real projects and responsibilities * Dedicated mentorship program pairing interns with experienced professionals * Networking opportunities with industry professionals and fellow interns * Internship events focused on professional and skills development * Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Brooklyn Park, MN U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: * Paid sick time * Civic Duty paid time off * Participation at company volunteer events * Participation at company sponsored special events * Access to on-site fitness center (where available) * Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Brooklyn Park, MN Worker Type Employee Worker Sub-Type Paid Intern (Fixed Term) (Trainee) Time Type Full time Job Exempt No
    $21-46 hourly 60d+ ago
  • Plasma Center Paramedic -EMT-P

    Takeda 4.7company rating

    Takeda job in Saint Paul, MN

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements Currently licensed or certified in the state where responsibilities will be assigned: EMT-Paramedic Current Cardiopulmonary Resuscitation (CPR) and AED certification Fulfill state requirements (in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in a clinical or hospital setting More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MN - Saint Paul U.S. Hourly Wage Range: $26.15 - $35.96 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - MN - Saint PaulWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No
    $26.2-36 hourly Auto-Apply 41d ago
  • Oncology Account Specialist (Breast) - Minneapolis North, MN

    Astrazeneca 4.6company rating

    Minneapolis, MN job

    Ready to make a difference in the lives of patients with cancer? As an Oncology Account Specialist (OAS) in the Minneapolis North market for the Breast team, you'll be at the forefront of transforming patient care and demonstrate your deep disease-area expertise to engage healthcare professionals through diverse media channels. Your role will involve leading interactions with healthcare providers, focusing on clinical selling and identifying customer needs for education. You'll work closely with the Oncology Business Manager to develop and manage account plans, using your understanding of the tumor patient journey to engage key partners across all relevant elements. Must live within the geography: Minneapolis MN, Fargo ND, Bismarck ND, Duluth MN, or surrounding areas Responsibilities: Learn account priorities for specific tumor types and local trends relevant to clinical practice. Conduct opportunity assessments and identifies multi-disciplinary customers within accounts across the patient journey to inform business priorities. Develop tumor-focused business plans based on key insights and engagement plans focused on key account partners. Work with peer field team members to identify cross-brand engagement opportunities. Provide critical input into geography-level priorities and plans. Educate and engage HCPs about efficacy, safety, and dosing profiles for FDA-approved indications. Educate on approved companion diagnostic tests and importance of appropriate patient identification. Minimum Qualifications: 3+ years of demonstrated Sales or Commercial experience within pharmaceutical, healthcare, scientific, clinical, institutional, or other relevant experience in related healthcare environments Bachelor's degree A valid driver's license and safe driving record Preferred Qualifications: Pharmaceutical sales experience Oncology sales experience in (specifically Breast, Lung, Hematology, Gynecology, Genitourinary, or Gastrointestinal cancer) Experience with successful launches and balancing a complex portfolio Track record of building customer relationships through various mediums (in-person and virtual) and strong sales goal achievements Ability to learn, analyze, understand and convey complex information Proactively embraces growth and innovation by seeking new ideas, adapting to change, and leveraging novel approaches and technologies to drive results and advance patient care. AstraZeneca offers a dynamic environment where innovation thrives. Our fast-paced culture encourages agility and responsiveness as we tackle unanswered questions in oncology. We foster a sense of urgency and collaboration, empowering diverse teams to bring transformative medicines to market. With a commitment to inclusion and belonging, AstraZeneca is a place where everyone can be themselves and contribute to advancing societal change. Join us in shaping the future of cancer treatment through innovation and excellence! Excited to make an impact? We have one seat available, and we hope it's yours. Apply now to join our team and help transform patient care in oncology! The annual base pay (or hourly rate of compensation) for this position ranges from $130,054 to $229,219 . Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 20-Jan-2026 Closing Date 08-Feb-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
    $61k-81k yearly est. Auto-Apply 8d ago
  • DDT Engineer Strategy and Business Excellence

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Lexington, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Pharmaceuticals USA, Inc. for the following job opportunity: JOB LOCATION: Lexington, MA POSITION: DDT Engineer Strategy & Business Excellence POSITION DESCRIPTION: Takeda Pharmaceuticals USA, Inc. is seeking a DDT Engineer Strategy & Business Excellence with the following duties: develop and enhance the Project & Portfolio Management (PPM) system, build scalable full-stack solutions and integrate seamless data processing for over 2000 users using .NET, Angular, and SQL; implement REST-based backend services, optimize data pipelines, and contribute to all phases of the software development lifecycle, including requirement analysis, design, development, testing, deployment, and maintenance; oversee and maintain an Agile Operating System used in manufacturing sites, ensuring security, performance, compliance, and disaster recovery planning; own and manage Reporting DataPoint & Power BI, ensuring data integrity, developing automated reports, and optimizing reporting methodologies for business insights; collaborate with cross-functional teams, including business stakeholders, data analysts, and UI/UX designers, to ensure seamless integration and user-friendly experiences; enhance cloud-based solutions, supporting migration efforts and optimizing cloud infrastructure for scalability, performance, and cost efficiency; troubleshoot and resolve technical issues, ensuring system reliability, minimizing downtime, and improving application performance through continuous monitoring and proactive optimizations. Up to 60% remote work allowed. REQUIREMENTS: Master's degree in Information Systems or related field plus 2 years of related experience. Prior experience must include: develop full-stack applications: design and implement web applications using frontend (React, Angular, or Vue.js) and backend (Node.js or .NET) technologies; database design and management: design, query, and optimize relational (SQL Server, PostgreSQL) databases, ensuring data consistency; software development lifecycle (SDLC): contribute to all SDLC phases, including coding, testing, code reviews, deployment, and maintenance; version control and CI/CD: use Git for source control and CI/CD tools (Jenkins, GitHub Actions, Azure DevOps) for automated deployments; UI/UX design and development: apply user experience principles to improve interface design, including wireframing and UI optimization. Full time. $137,000-$234,800 per year. Qualified applicants can apply at ************************ Please reference job #R0171455. EOE Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
    $137k-234.8k yearly 19d ago
  • Phlebotomist

    Takeda 4.7company rating

    Takeda job in Maple Grove, MN

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MN - Maple Grove U.S. Starting Hourly Wage: $18.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - MN - Maple GroveWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time Job Exempt No
    $18 hourly Auto-Apply 8d ago
  • Head of Manufacturing Strategy and Innovation

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Lexington, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: As the Head of Manufacturing Strategy and Innovation (MSI), you will be responsible for leading strategic initiatives that drive innovation, transformation, and operational excellence within manufacturing. You will focus on developing a forward-looking manufacturing strategy, encouraging continuous improvement, and allowing advanced technologies and processes to promote business growth and agility. Operating at the intersection of strategy, transformation, and manufacturing excellence, the MSI oversees site-wide manufacturing improvement initiatives, budget planning, and cultural transformation. This role partners with local Manufacturing Leadership, Business Excellence (BE), Digital, Data & Technology (DD&T), and other key stakeholders to ensure alignment, create value, and drive the continuous enhancement of manufacturing processes. The position makes a significant contribution to sustaining performance and operational efficiency across Manufacturing. You will report into the Head of Manufacturing. How you will contribute: * Develop and implement a comprehensive manufacturing strategy aligned with site and corporate objectives * Drive innovation initiatives to enhance manufacturing efficiency, flexibility, and sustainability * Lead transformation projects, including digitalization, automation, and advanced analytics adoption * Collaborate with cross-functional teams to ensure seamless integration of new technologies and processes * Establish governance and performance metrics to monitor progress and ensure accountability * Foster a culture of continuous improvement, innovation, and operational excellence across manufacturing sites * Provide strategic oversight for tech transfers, new product introductions, and capacity expansion projects * Promote financial discipline by collaborating with Manufacturing, BE, and Finance partners on budget planning (MRP/MYC), aligned with strategic goals * Optimize resource planning, manage budgets effectively, and prioritize initiatives to create value Minimum Requirements/Qualifications: * Bachelor's degree or equivalent experience in Engineering, Science, or related field * 8+ years of experience in manufacturing strategy, operations, or related leadership roles within biotechnology or pharmaceuticals * Proven track record of driving innovation and transformation in manufacturing environments * Demonstrate end-to-end process understanding to enable a strategic, big-picture perspective * Proficient in strategy deployment, continuous improvement, and methodologies * Change management skills * Deep understanding of cGMP and regulatory requirements * Expertise in digital manufacturing, automation, and advanced analytics More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Lexington - BIO OPS U.S. Base Salary Range: $153,600.00 - $241,340.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Lexington - BIO OPS Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes 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.
    $77k-109k yearly est. 1d ago
  • 2026 Summer Internship Program: Manufacturing Sciences - Downstream Intern

    Takeda Pharmaceuticals 4.7company rating

    Takeda Pharmaceuticals job in Brooklyn Park, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** The Manufacturing Sciences Downstream group supports the development, transfer, and lifecycle management of purification and filtration unit operations used in biologics manufacturing. This team ensures robust downstream process performance by executing some process development, tech transfers, process validation, lifecycle management and evaluating new technologies for implementation. The downstream team designs and executes studies that will efficiently and accurately evaluate process changes or optimizations. As an intern in the Manufacturing Sciences Downstream group, you will be immersed in a dynamic, cross-functional environment that bridges technical operations, quality control, and process development. This team plays a key role in ensuring the robustness and reliability of purification and filtration unit operations used throughout the lifecycle of biologic products-from early development through commercial manufacturing. You'll be part of a collaborative group supporting process development, scale-down model generation, deviation investigations, and the evaluation and implementation of new technologies. Over the 12-week internship, you will own one or more projects and collaborate with your manager, mentor, and team members to execute them. This experience will help you build technical skills, scientific reasoning, and business acumen while contributing to the delivery of high-quality biologic therapies. **How You Will Contribute:** Duties may include some of the following, under the manager's and/or mentor's supervision: + Support process development and optimization for biologics manufacturing. + Assist with downstream lab activities, including documentation, data review, and performance tracking. + Participate in scale-down model generation to simulate manufacturing conditions. + Contribute to deviation investigations and root cause analyses. + Help evaluate and implement new technologies to enhance analytical capabilities and data integrity. + Collaborate cross-functionally with Quality Control, Manufacturing, and Quality teams. + Gain exposure to GMP documentation practices and regulatory expectations in a biologics setting. **Internship Development Opportunities:** Interns will gain exposure to: + Operating within industry guidelines for controlled scientific experiments. + Approaches to solving real-world problems in drug development. + An introduction to regulatory requirements for biologics manufacturing. + Purification and filtration techniques commonly used in biologics production. **Job Requirements:** + This is a full-time, on-site position (40 hours/week). + Must be pursuing a Bachelor's or Master's degree in a scientific or engineering discipline. + Prior laboratory experience required (e.g., academic lab courses, guided research). + Comfortable working in a dynamic environment where plans may evolve. + Confident in working with and interpreting scientific data. **Internship Eligibility** + Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship + Must be currently enrolled in a degree program graduating December 2026 or later + The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) + The intern must be able to commit to one of these time frames + Able to work full time 40 hours a week during internship dates + Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program ** ** **Program Highlights:** + Hands-on experience with real projects and responsibilities + Dedicated mentorship program pairing interns with experienced professionals + Networking opportunities with industry professionals and fellow interns + Internship events focused on professional and skills development + Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd **Takeda Compensation and Benefits** **Summary** We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** Brooklyn Park, MN **U.S. Hourly Wage Range:** $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: + Paid sick time + Civic Duty paid time off + Participation at company volunteer events + Participation at company sponsored special events + Access to on-site fitness center (where available) + Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Brooklyn Park, MN **Worker Type** Employee **Worker Sub-Type** Paid Intern (Fixed Term) (Trainee) **Time Type** Full time **Job Exempt** No
    $31k-37k yearly est. 60d+ ago
  • Staff Device Engineer

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Lexington, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Primary Role: The Staff Device Engineer will lead technical efforts for combination products and drug delivery device projects with limited oversight. As a hands-on technical lead/contributor and device subject matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive collaboration with internal and external partners. This role supports as well a team of device engineers responsible for all the technical aspects of life cycle management of commercialized Combination Products, Medical Devices and pre-filled syringe among others. This role works with cross functional team to support lifecycle management of commercial combination product. The Staff Device Engineer has extensive experience in medical devices for drug delivery including combination products, solid understanding of polymeric medical device manufacturing processes via molding and assembly, and solid knowledge of global standards for the combination products. This key technical role is responsible for change controls, manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role interacts with external CLO and CMO and vendors, works closely with drug product, quality, regulatory, program leadership, etc. and establish strategic working relationships. Responsibilities: * Plans and coordinates work with departmental and cross functional peers (within and outside Pharm Sci) with an understanding of project timelines/deliverables and define risks and recommend contingency plans as required. * Evaluates impact of decisions across CMC functions. * Makes significant independent contributions to complex pipeline or functional area project. May significantly contribute to more than one project within functional area. * Independently designs, executes and reports results. Proactively analyses manufacturing issues and coordinates potential solutions with the CMC team. Assists in the technical aspects of negotiation with vendors. * Coordinates support of specific technical issues related to projects * May proactively address issues during or resulting from manufacturing. * Provide technical leadership and contribution on cross functional teams for devices through clinical development, product registration and commercialization. Own and lead the creation of design control deliverables to comply with medical device and combination device regulations. * Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. * Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. * Lead or assist in deviation, complaint and failure investigations. Education and Experience Requirements: * Bachelor's degree and 8+ years relevant industry experience or master's degree and 6+ years relevant industry experience, or PhD and 0+ years in the field of combination product or medical device development and commercialization is desired. * Minimum of 6 years leading cross functional teams and projects. Hands on technical support and lab skills for measurement using various instruments required * Experience supporting regulated devices / combination products under Design Control (21 CFR 820), ISO13485, and ISO14791 requirements. * Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc.). * Hands on technical leadership skills with a track record of supporting on- the market products and delivering new products to market * Design for Six Sigma (DFSS) certification is desirable. * Prior experience leading & supporting projects that include managing external design, development, and manufacturing partners. * Prior technical leadership experience with creating design control/technical file deliverables and manufacturing scale-up a plus. * Proven track record of developing and gain regulatory approval of drug delivery systems a plus * Working knowledge of solid works desirable. Key Skills and Competencies: * A strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO14971. * Extensive knowledge of engineering principles, concepts and applications. * Self-starter with strong planning and organizational skills. * An aptitude for project foresight and contingency planning. * Effective planning and organizational skills. * Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences * Strong knowledge of project management techniques, tools and metrics. * Ability to mentor technical and cross functional team members. * Strong collaboration skills with external partners. Other Job Components: Complexity and Problem Solving: * Develops and implements novel approaches and tools for data collection, management, engineering, analysis, modeling, and interpretation. * Reviews, interprets data and communicates results with Pharm Sci functions and CMC team. Planning and implementation of solutions to project problem/issues * Coordinates tech transfer with vendors. * Stays updated on related technologies/methodologies and proposes options to implement within area of expertise * Drive the evaluation of complex drug delivery systems and provide sound technical recommendations to move projects forward. * Identify, communicate and lead device design control process evolution to meet device regulations. Internal and External Contacts: * Collaborate with commercial Product teams, Quality, Mfg, Regulatory, R&D, Clinical, Legal * Work closely with Contract Lab Organizations (CLOs), Contract Manufacturing Organizations (CMOs) * Communicates activities from their functional area to project teams (pipeline, non-pipeline, and functional initiatives) and requests functional area action from the project teams to senior leaders in their functional area. * Has authority as a technical project leader to commit available resources to execute specific project tasks for project teams (pipeline, non-pipeline, and functional initiatives) upon request * May fully represent their functional area to a project teams (pipeline, non-pipeline, and functional initiatives with narrow focus) May identify topics for functional initiatives * Work closely with external design, development and manufacturing partners Functional training for multiple laboratory technologies: * Develops and uses basic knowledge of cross functional departments to guide junior colleagues on impact of changes and inter- dependencies. * Develops expertise in multiple laboratory technologies and leverages as functional area resource and trainer. * May have responsibility for training/mentoring of junior colleagues Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Lexington, MA U.S. Base Salary Range: $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes 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.
    $111.8k-175.7k yearly 56d ago
  • Senior Environmental, Health and Safety Specialist II

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Lexington, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: This is a key leadership opportunity for an experienced EHS professional ready to make a visible impact in a cutting-edge biopharmaceutical manufacturing environment. The Senior EHS Specialist II serves as a strategic EHS leader and technical expert partnering closely with manufacturing, laboratory, warehouse, and engineering teams to drive a proactive safety culture and ensure compliance excellence. This position is ideal for an EHS professional who thrives in a collaborative environment, enjoys influencing without direct authority, and is motivated by solving complex problems, leading projects, and shaping the site's safety and sustainability journey. How you will contribute: * Be a Site Safety Leader: Partner with manufacturing and laboratory leaders to embed EHS into daily operations and build a culture of care, ownership, and accountability. * Lead Core EHS Programs: Own high-impact programs such as Machine Guarding, LOTO, Confined Space, and Fall Protection. Develop and implement improvements that enhance compliance and reduce risk. * Influence & Coach: Serve as a trusted EHS advisor for supervisors, engineers, and technicians. Coach others to identify hazards and implement sustainable solutions. * Project Leadership: Act as EHS lead for large capital and engineering projects-ensuring safe design, construction, and startup. * Incident Prevention & Investigation: Facilitate incident investigations with a focus on learning, root cause analysis, and continuous improvement. * Data-Driven Improvements: Analyze EHS data, identify trends, and communicate performance insights to leadership for informed decision-making. * Engage the Workforce: Lead site safety committees, mentor EHS champions, and partner with cross-functional teams to strengthen Takeda's high-performance safety culture. Minimum Requirements/Qualifications: * 10+ years' experience in the EHS field with a minimum of 3 years in a high pace/high volume manufacturing environment. * BS/BA required in technical discipline: engineering, safety, industrial hygiene, environmental studies, life science or similar field. * Professional certification (CSP, CIH, CHMM, etc.) and/or master's degree in a related field, preferred. * Experience with ISO 14001, 45001 management systems, LEAN, Six Sigma methodology, preferred. * Experience supporting technology transfers, process scale ups, and process hazard analysis, preferred. Additional Considerations: * This role is based in Lexington, MA with occasional travel to nearby sites. * Work may include cleanroom gowning and PPE requirements, and occasional off-hour support for projects or emergencies. * Ability to operate a car (valid driver's license) and travel via air, rail or other means of passenger conveyance. * May involve occasional work in a cold, hot, high noise, at heights, or wet environment. * Must be able to crouch, climb, lift, push, pull and carry up to 25 lbs. and remain standing or walking for extended periods. * In general, the position requires a combination of sedentary work and walking around observing conditions. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Lexington - BIO OPS U.S. Base Salary Range: $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Lexington - BIO OPS Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes 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.
    $57k-75k yearly est. 60d+ ago
  • Site Microbiologist

    Takeda Pharmaceuticals 4.7company rating

    Takeda Pharmaceuticals job in Brooklyn Park, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** About the role: As the Site Microbiologist, you will oversee activities within the facility to ensure the microbial quality, safety, and compliance of pharmaceutical products, raw materials, utilities, cleanrooms, and manufacturing processes. You will support routine operations, investigations, environmental monitoring (EM), contamination control strategies (CCS), method development, and regulatory compliance within GMP environments. You will hold a PhD in Microbiology or a related field and have experience in virology within a regulated environment. You will report into the Site Quality Head. **How you will contribute:** + Perform and/or oversee microbiological testing including bioburden, endotoxin, sterility testing, microbial identification, growth promotion, and water system monitoring + Ensure all testing complies with GMP, SOPs, and pharmacopeial standards + Oversee troubleshooting and qualification of microbiology laboratory equipment and advanced microbial detection systems + Manage the Environmental Monitoring (EM) program, including trend analysis, alert/action limit review, and CAPA activity + Support and continuously improve the site's Contamination Control Strategy (CCS) + Supervise personnel monitoring, viable and non-viable particulate monitoring, and surface sampling in compliance with EU GMP Annex 1 and FDA guidance + Lead microbiology-related investigations, including EM excursions, OOS/OOT results, sterility failures, and water-system deviations + Provide microbiological expertise in risk assessments, CAPAs, change controls, and root cause analyses + Collaborate with QA, Engineering, and Operations to proactively identify and mitigate contamination risks. **Minimum Requirements/Qualifications:** + PhD in Microbiology, Virology, Biotechnology, or a closely related life sciences discipline + 3-7 years of experience in pharmaceutical microbiology + 3+ years of experience with GMP, aseptic processing, and regulatory microbiology requirements + 3+ years of experience in environmental monitoring, sterility assurance, and contamination control **More about us:** At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** Brooklyn Park, MN **U.S. Base Salary Range:** $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Brooklyn Park, MN **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** Yes
    $37k-49k yearly est. 18d ago
  • Technical System Owner

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Lexington, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Technical Systems Owner works closely with the manufacturing teams and DDT leaders to execute the digital strategy roadmap. You lead the support and ownership of technical systems ensuring flawless operation for a growing portfolio of application/systems across various domains (e.g. Manufacturing, Supply Chain, Quality, Engineering, Finance, HR, Procurement, EHS, etc). How you will contribute: * Analyze complex business processes to identify, evaluate, develop and/or redesign systems, processes, and procedures to meet user requirements on large initiatives. * Create detailed written user requirements. * Provide consultation to customers on business process redesign. * Assist in the development of system documentation and training materials as well as training processes * Act as the technical system owner for digital solutions within your assigned domain * Collaborate with application SMEs to understand systems and interfaces ensuring good data quality of the data exchange during usage * Encourage the re-use of existing digital technologies to automate and simplify repetitive tasks * Exhibit a continuous improvement (CI) mindset to automate and simplify repetitive tasks leveraging workforce automation * Persuade others with fact-based judgments of business situations to apply technical solutions What you bring to Takeda: * Bachelor's degree preferred or relevant work experience in systems or business. * 5+ years' experience in applying information systems solutions to business problems * Good understanding of the available Digital technology platform and their applicability in the pharmaceutical industry (e.g., Data Visualization & Analytics, Robotic Process Automation, IoT, Paperless technologies). * Experience in system testing, validation, problem resolution, and training. * Strong communication and interpersonal skills. * Experience in Manufacturing, Process and Pharmaceuticals industrial preferred * Gather, understand, and document business processes, objectives, specifications, and requirements on medium/large size projects to support systems within your technical domain. * Possess strong and effective self-management and time management skills. * Ability to effectively communicate and influence others across all levels of the organization to drive transformational change. * Ability to write and speak in the English language. * Excellent oral and written communications skills, business acumen with analytical, critical thinking and problem-solving skills. * Proficient communication skills to capture business requirements from a complex business partnering relationship between functions and apply technical solutions. * Presentation skills to facilitate discussions and present findings to leadership teams and subject matter experts. * Technical experience and troubleshooting knowledge * Strong communication and interpersonal skills. Ability to work & influence effectively in a cross functional setting Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: * Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. * Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. * Work in a cold, wet environment. * Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. * Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. * Access to transportation to attend meetings. * Ability to travel to meetings regionally and globally. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. #GMSGQ #ZR1 #LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Lexington - BIO OPS U.S. Base Salary Range: $86,500.00 - $135,960.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Lexington - BIO OPS Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes 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.
    $86.5k-136k yearly 6d ago
  • Associate Director, API Process Engineering

    Takeda Pharmaceutical Company Ltd. 4.7company rating

    Takeda Pharmaceutical Company Ltd. job in Brooklyn Park, MN

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role As Associate Director, API Process Engineering, you will be Takeda's global expert for small-molecule API manufacturing processes across batch and continuous platforms. You will apply chemical engineering and process chemistry fundamentals to design, scale, and control API processes from clinical development through commercial supply. Through the integration of mechanistic modelling, process simulation, and rigorous data analysis you will deepen process understanding, strengthen control strategies, and support regulatory submissions for global markets. You will become the central hub for API process knowledge, driving best practices and continuous improvement across Takeda's manufacturing network and external CMOs. How you will contribute * Lead the Small Molecules API Manufacturing Sciences activities within Global Process Science, serving as expert for small-molecule API processes and technologies. * Provide process engineering support for batch and continuous API platforms from clinical through commercial stages, integrating process chemistry and engineering perspectives. * Apply mechanistic modelling, process simulation, and quantitative analysis to enhance process understanding and enable robust process control. * Lead API manufacturing process characterization, including risk assessments and definition of critical process parameters and controls. * Lead technology transfer of API processes between internal sites and external CMOs, ensuring robust, reproducible, and compliant implementation. * Lead API process validation activities, including strategy, protocol design, execution support, and data evaluation. * Develop and implement strategies for continuous improvement of marketed API processes, including yield optimization, robustness improvements, cost of goods (COGs) reduction, and capacity expansion. * Establish and maintain systems and procedures for best practice in commercial technology transfer and process validation. * Build and oversee a central knowledge base of API process and product understanding, ensuring lessons learned are shared across products, sites, and functions. * Collaborate closely with GMS functions (e.g., Small Molecules Operations Units, network strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC. * Provide technical support to marketing applications for global markets and lead preparation of responses to regulatory questions from health authorities. * Utilize structured root cause analysis techniques to investigate process and equipment issues and deliver robust, sustainable corrective and preventive actions. * Provide subject matter expertise for due diligence in mergers and acquisitions and in-licensing evaluations. What you bring to Takeda * At least a Master's degree in an area related to Chemical Engineering, Process Engineering, or Pharmaceutical Engineering. * At least 5 years of experience in a cGMP manufacturing environment and at least 5 years of pharmaceutical industry experience in small-molecule APIs (these may overlap). * Strong foundation in organic/pharmaceutical chemistry and chemical engineering, with applied experience in API manufacturing processes. * In-depth understanding of pharmaceutical manufacturing processes, ICH guidelines, and current global regulatory requirements relevant to API processes. * Demonstrated experience in mechanistic modelling, process simulation, and data-driven process optimization. * Proven track record leading API process characterization, technology transfer, process validation, and lifecycle changes in a multi-site or global context. * Strong problem-solving, project management, and stakeholder management skills, including the ability to resolve conflicts and drive clear decisions in cross-functional teams. * Excellent written and verbal communication skills, including experience preparing high-quality technical reports and presenting project results to diverse audiences. * Ability to work independently and proactively while collaborating effectively within multi-disciplinary teams (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC teams, and others). * Commitment to sharing knowledge across functions and sites and to building sustainable technical capabilities in the organization. * Intellectual curiosity about technology and new ways of working, coupled with a collaborative and open mindset. * Willingness to travel to our international manufacturing sites and work side-by-side with site teams on highly complex issues More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. Locations Zurich, SwitzerlandBEL - Lessines, CHE - Neuchatel, Hikari, Japan, IRL - Bray - Production, IRL - Dublin - Baggot Street, IRL - Grange Castle - Production, Lexington, MA, SGP - Singapore - Woodlands, USA - CA - Thousand Oaks - Rancho Conejo, USA - MA - Cambridge, USA - MN - Brooklyn Park Worker Type Employee Worker Sub-Type Regular Time Type Full time
    $85k-105k yearly est. 57d ago

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