Director of Analytical Operations

4 days ago


Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

Takeda Pharmaceutical seeks an exceptional leader to oversee its global team of managers and scientists in the field of analytical controls and compliance. As Director of Analytical Operations, you will be responsible for leading core tasks for analytical controls, contributing to product development, and implementing externalization activities with external partners.

Key Responsibilities:
  • Lead and develop a global team of managers and scientists in the field of analytical controls and compliance.
  • Oversight of Pharmaceutical Sciences (PS) with management and oversight of all project-related analytical control topics, development requirements, and program milestones including global reporting.
  • Oversee and manage core tasks for Analytical controls for clinical trial material efforts across four main areas: GMP review and control for analytical documents; Release testing oversight, Stability and Shelf life; Reference Standard Management; GMP Quality Systems.
  • Contribute to product development from Research to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process, and product knowledge.
  • Implement and execute externalization activities with external partners, facilitate development of execution plans for each, and ensure completion of agreed upon activities.

The estimated salary range for this position is $160,000 - $200,000 per year, depending on qualifications and experience. U.S. based employees may be eligible for short-term and/or long-term incentives, 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.



  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Embark on a challenging career opportunity with Takeda Pharmaceutical as we seek an experienced Director of Global Analytical Development to lead our team in Cambridge, MA.Job OverviewWe are looking for a highly skilled and motivated individual to oversee the development of analytical control systems, ensuring compliance with regulatory requirements. The...


  • Cambridge, Massachusetts, United States Ipsen Full time

    About Our TeamWe are a global biopharmaceutical company dedicated to making a difference in people's lives through innovative therapies. Our team is passionate about delivering exceptional results and creating a positive impact on the communities we serve. As an Associate Director, Channel Intelligence, you will have the opportunity to work with...


  • Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    About the RoleWe are looking for an experienced Investment Analytics Engineer to join our team at MIT. The successful candidate will have the opportunity to work on designing and building applications for investment analytics and operational data management in a department within MIT.The CompanyMIT is a leading institution that manages over $30 billion in...


  • Cambridge, Massachusetts, United States Biogen Full time

    **Unlock Your Career with Biogen**About This RoleThis is a dynamic opportunity for an experienced Marketing Operations professional to join our North American team at Biogen. As Associate Director, Marketing Operations Digital Production, you will be a critical partner to our US marketing teams, driving the execution of digital marketing tactics and...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    Job Overview:Nuvalent is seeking an experienced Associate Director, Analytical Sciences to lead the strategic analytical aspects of drug substance and drug product development and manufacturing activities.The ideal candidate will have a strong understanding of cGMP/ICH regulations and USP Guidelines, with expertise in late-phase small-molecule drug substance...


  • Cambridge, Massachusetts, United States Biogen Full time

    About BiogenWe are a global biotechnology company committed to excellence, driven by innovation, and passionate about making a difference in patients' lives. Our team comprises talented professionals who share a pioneering spirit and contribute significantly to our mission.Job DescriptionWe are seeking an experienced Global Director of Insights and...


  • Cambridge, Massachusetts, United States Thermo Fisher Scientific Full time

    **Job Title:** Lab Operations DirectorThermo Fisher Scientific is seeking an experienced Lab Operations Director to oversee the daily operations of our laboratory. As a key member of our team, you will be responsible for ensuring seamless execution of tasks and processes, while maintaining high levels of quality and safety.Salary: $100,000 - $125,000 per...


  • Cambridge, Massachusetts, United States Marengo Therapeutics, Inc. Full time

    About Marengo Therapeutics, Inc.Marengo Therapeutics is a pioneering biopharmaceutical company dedicated to developing innovative therapeutics that activate the right immune response to promote lifelong protection against cancer. Our team is passionate about making a meaningful difference in the lives of patients and their loved ones.Job OverviewWe are...


  • Cambridge, Massachusetts, United States Kalvista Pharmaceuticals Inc Full time

    Job OverviewKalVista Pharmaceuticals Inc is seeking an experienced Finance Director to partner with the Commercial organization, driving financial planning and analysis. As a vital member of our team, you will play a key role in supporting all financial aspects of the Commercial function.About UsKalVista Pharmaceuticals Inc is a global pharmaceutical company...


  • Cambridge, Massachusetts, United States EverQuote Full time

    About the PositionWe're looking for an Analytics Solutions Architect to join our team. As a key member of our Enterprise BD team, you'll work closely with clients to develop data-driven solutions and drive forward projects independently. Key responsibilities include:Developing dashboards and alerts to quickly capture and investigate deviations in...


  • Cambridge, Massachusetts, United States Boston Properties, Inc. Full time

    About Our Company Boston Properties, Inc. is a leader in the real estate industry, committed to delivering exceptional results and value to our clients and stakeholders. Salary: $280,000 per year Job Summary We are seeking an experienced Director of Engineering Operations to join our team in this critical role. The successful candidate will have a proven...


  • Cambridge, Massachusetts, United States Harvard University Full time

    Harvard University is seeking an Associate Director for IT Operations to join our team. This role is responsible for overseeing the daily operations of our IT systems, including the configuration, scripting, testing, scheduling, and maintenance of several hundred term-based batch workflows for the Extension and Summer Schools. The successful candidate will...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Welcome to Takeda Pharmaceutical, a world-leading biopharmaceutical company dedicated to improving lives through innovative medicines.About Us:We strive to create a diverse and inclusive work environment that fosters collaboration, creativity, and growth. Our commitment to equality and fairness has earned us recognition as an employer of choice.Job...


  • Cambridge, Massachusetts, United States Biogen Full time

    Transforming Commercial Success with Data-Driven LeadershipBiogen is seeking an accomplished Data Insights Director to lead our commercial strategy and drive business growth.About Biogen:We are a global biotechnology company committed to excellence and innovation. With a strong focus on patient-centricity, we strive to deliver life-changing medicines that...


  • Cambridge, Massachusetts, United States Mass General Brigham Full time

    About the RoleMass General Brigham is seeking a highly skilled Operating Room Nurse Director to lead our team in Cambridge, Massachusetts.Key ResponsibilitiesTo supervise and direct a team of registered nurses and support staff in the operating room environmentTo ensure seamless patient flow and efficient use of resourcesTo promote a culture of excellence...


  • Cambridge, Massachusetts, United States Harvard University Full time

    Job Title: Associate Data EngineerAbout the Role:We are seeking a highly skilled Associate Data Engineer to join our team at Harvard University. The successful candidate will be responsible for developing, testing, deploying, and maintaining software, including web applications, learning platforms, APIs, daily ETL data operations, infrastructure, and data...


  • Cambridge, Massachusetts, United States Harvard University Full time

    Harvard University seeks a highly skilled and experienced professional to fill the role of Director of Administrative Operations for the Arts & Humanities Division. This position is a crucial part of the team responsible for managing and overseeing various administrative functions within the division. The successful candidate will be working closely with the...


  • Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    Job Summary:We are seeking a highly skilled Strategic Operations Coordinator to join our team at the Massachusetts Institute of Technology. As a key member of our operations team, you will be responsible for providing administrative support to our events and finance departments.About the Role:The Strategic Operations Coordinator will perform complex...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    Job OverviewWe are seeking a highly skilled Global Clinical Operations Director to lead our clinical development planning and strategy. The successful candidate will be responsible for aspects of clinical study planning and execution within pre-specified timelines and budget.About the RoleLead and manage integration of all project team activities, leveraging...


  • Cambridge, Massachusetts, United States Sarepta Therapeutics Full time

    Are you a seasoned clinical data management professional looking for a new challenge? Do you have experience in managing external data providers, developing standards and data transfer specifications, and collaborating closely with IT colleagues? If so, we want to hear from you!About the JobAs a Senior Director of Clinical Operations, you will be responsible...