Sebela Pharmaceuticals jobs - 375 jobs

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women's Health. Our Vision is to build the leading Gastroenterology company in the U.S., with a complementary focus on innovation in Women's Health, premised on our expertise in pharmaceutical development and commercialization. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has its contract development and manufacturing organization (CDMO) in Holbrook, MA, offering pharmaceutical-development and in-house manufacturing services for specialty gastroenterology products. We value dedication, energy, and enthusiasm, and we focus on innovation and results while striving to achieve our corporate mission and vision. Sebela Pharmaceuticals is committed to cultivating an inclusive environment where all employees are treated with respect. We accomplish this by fostering a culture of diversity, equity and inclusion, which is essential to innovation and continuous improvement. Sebela operates from three locations in Roswell, Georgia, Braintree and Holbrook, MA and headquarters in Dublin, Ireland. The Site Head of Quality provides leadership, direction and quality oversight for our Holbrook manufacturing site. This position is responsible for the development, implementation and maintenance of quality assurance systems and activities and will collaborate closely with team members at all levels to ensure compliance with all relevant cGMP regulations and guidelines. This individual will provide QA expertise and guidance in support of the development and product quality strategy and will be responsible for execution of the day-to-day quality activities. This role reports to the Chief Operating Officer. PRINCIPAL DUTIES AND RESPONSIBILITIES Effectively manage resources within Quality department in a manner that supports the delivery of the company's goals and objectives for regulatory compliance and product quality. Provide strong leadership and support to quality team members ensuring a collaborative, positive team environment. Monitor manufacturing operations for compliance to regulations, SOPs and batch records. Ensure products are always manufactured according to batch records and within cGMPs. Ensure the site maintains a state of ‘continuous' regulatory inspection readiness, including preparation for, participation in and follow up on inspections by regulatory authorities. Interact with CDMO customer contacts on quality and operational matters. Verify manufacturing operations are following Good Manufacturing Practices (GMPs), as outlined in the CFR, FDA Guidance Documents, ICH guidance documents. Coordinate resolution of vendor related issues. Review and approve manufacturing protocols, qualifications, and summary reports. Collaborate with the investigations department to ensure quality related issues are resolved thoroughly, in a timely manner, and incorporate cross functional processes to determine root cause. Participate in internal and external audits. Analyze data to identify areas for improvement in the quality system. Other duties as assigned. QUALIFICATIONS & REQUIREMENTS: Bachelor's or master's degree in chemistry, biology or pharmacy 10+ years of experience working in pharmaceutical product manufacturing with experience in compliance, and quality assurance. Direct experience interacting with U.S Food and Drug Administration and other regulatory agencies. Strong knowledge and understanding of FDA cGMP regulations. Experience with and fundamental understanding of FDA regulations and guidance documents. Experience leading GMP audits, and hosting on site FDA inspections covering drug product manufacturing and analytical testing sites. Understanding of process validation and/or IT compliance. CDMO experience preferred but not required. Experience in defending processes, procedures and investigation during regulatory inspections. Strong interpersonal, communication and influencing skills. Ability to foster excellent working relationships across all levels within the organization. Highly effective leadership skills with demonstrated success in building high-performing teams. A true self starter, who works effectively on their own initiative, and is used to working in demanding environments with continuous change and ambiguity. Strong problem-solving ability to evaluate quality matters and make decisions utilizing risk-based approach. Salary Range: $200-270K annual salary (this reflects our reasonable and good faith estimate of what will be paid at the time of posting). Competitive benefits package included.

A leading pharmaceutical company is seeking an Access Marketing Lead for its Oncology division in Boston, MA. You will oversee the Patient Value & Access strategy for an upcoming product launch, ensuring comprehensive preparation and execution. This role requires extensive experience in the pharmaceutical industry and oncology market access. Key responsibilities include managing market insights and collaborating across departments. A robust background in healthcare strategy and project management is essential for success. #J-18808-Ljbffr

A global biopharmaceutical company in Boston seeks a Global Therapeutic Research Lead to manage critical drug discovery projects within gastroenterology and inflammation. You'll leverage extensive experience in drug discovery to lead project strategies, provide mentorship to teams, and drive innovations. Candidates must have a PhD and at least 15 years of industry experience. The role is hybrid with competitive compensation and comprehensive benefits. #J-18808-Ljbffr

A leading biopharmaceutical company in Boston seeks a Research Scientific Director to spearhead AI/ML-enabled biologics discovery. This role drives the application of AI across drug development and demands a PhD with extensive experience in computational biology and machine learning. The successful candidate will lead strategy development, ensure scientific excellence, and foster an innovative team culture. The position offers a competitive salary, hybrid work options, and robust benefits. #J-18808-Ljbffr

A leading pharmaceutical company is seeking an Associate Director to enhance capabilities within the oncology team. You will lead training initiatives, develop comprehensive learning programs, and drive field performance. The ideal candidate has 8+ years of experience in pharmaceutical sales or account management, specifically in oncology, with a strong focus on leadership and strategy. The position offers a base salary range of $153,600 - $241,340 and supports a hybrid work model. #J-18808-Ljbffr

A leading pharmaceutical company seeks a qualified individual to join the Statistics and Quantitative Sciences team in Boston. The role focuses on leading clinical trial projects, implementing effective delivery strategies, and collaborating across functions to enhance drug development processes. Candidates must possess advanced knowledge in clinical study design, FDA regulations, and robust statistical skills. A PhD with relevant experience is preferred, along with strong leadership and communication abilities. Competitive salary and comprehensive benefits are offered. #J-18808-Ljbffr

A leading biopharmaceutical company in Boston is looking for a highly skilled individual to lead the delivery of clinical strategies. This role involves facilitating collaboration across teams, implementing effective risk mitigation strategies, and ensuring high-quality statistical analysis for innovative drug development. Ideal candidates should have advanced statistical programming skills, a PhD or MS, and strong communication abilities. The position offers competitive compensation and a comprehensive benefits package. #J-18808-Ljbffr

A leading pharmaceutical company in Boston is seeking an experienced Associate Director to lead training initiatives within the Oncology team. The role involves developing comprehensive training programs and collaborating with sales leaders to enhance team capabilities. Candidates should have a strong background in pharmaceutical sales, preferably in oncology, along with leadership and project management skills. This position offers a competitive salary and a hybrid work environment. #J-18808-Ljbffr

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 an Advanced Process Modeling Expert, you will develop, deploy, and maintain advanced process models and digital twins that drive control and optimization strategies across manufacturing processes, both for unit-operations and end-to-end. Developing custom code, leveraging digital modeling tools, and robust data infrastructure, you will develop mechanistic, hybrid, or AI/ML-based models for dynamic simulation, forecasting and soft-sensing. Your work will enhance process understanding, support tech transfers, and strengthen overall process capability and product quality. How you will contribute * Develop mechanistic, hybrid, and statistical/ML models for unit operations (e.g., bioreactors, chromatography, filtration, UF/DF), applying first principles like mass & energy balances, reaction kinetics, thermodynamics, and transport phenomena. * Build dynamic digital twins for scenario analysis, scale-up/scale-down evaluation, material-balance verification, and manufacturing tech transfer readiness. * Own the full lifecycle of digital process models, from conceptual design to implementation, deployment, monitoring, and retraining. * Prepare and structure data for dry-lab simulations by integrating sensor/historian, batch records, and Manufacturing Sciences lab data. * Develop soft sensors for non-measurable or slow-to-measure process parameters using mechanistic correlations, ML regression, and hybrid approaches. * Drive manufacturing optimization initiatives such as cycle-time reduction, yield improvement, process robustness studies, root-cause analyses, and failure-mode simulations. What you bring to Takeda * Bachelor's degree in a STEM field (Chemical or Biochemical Engineering preferred); Master's or PhD is an advantage. * Minimum of 3 years in pharmaceutical manufacturing, familiar with cGMP requirements. * Experience in digitizing industrial processes, computational modeling, process simulation, soft-sensor development, and data analytics. * Proficiency in AI, machine learning, and statistical methods for data-driven decision-making. * Strong expertise in scientific modeling: mechanistic and hybrid modeling; experience with flow-sheeting software such as gPROMS. * Familiarity with Discoverant, SIMCA Online/Offline, OSI PI, Databricks, and AWS is a plus. * Strong programming skills in Python (Julia is a plus). * Familiarity with Agile project management (Scrum/Kanban in Jira) is advantageous. * Clear communicator capable of explaining technical concepts to non-experts. * Curious and open to leveraging new digital tools and methodologies to improve industrial processes. * Fluent in English 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, SwitzerlandCambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Objectives: Takeda's mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders. The R&D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda's R&D pipeline. Central to Takeda's R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data‑driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics & Quantitative Sciences, Programming, Global Evidence Outcomes, Patient Safety & Pharmacovigilance, and Strategic Operations. The department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting‑edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross‑functionally to ensure scientific rigor and compliance with regulatory standards in all decision‑making processes. As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. Delivery & Business Accountabilities Lead delivery for one or more assets at GPT level or specialty area in clinical Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Create an internal cross functional and external with vendors sphere of influence in predictable delivery Identify opportunity for continuous improvement in delivery approaches and leverages fit‑for‑purpose mitigations by leveraging them Contributions Asset‑level GPT strategy and delivery Broadly DQS functions Parts R&D functions. Core Elements Related to this Role Advanced knowledge of clinical study designs, analysis methodology and data interpretation. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross‑functional interfaces with the Statistics function. Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions. Strong statistical programming skills Excellent oral and written communications skills. Specialized statistical expertise in multiple therapeutic areas or development phases. Strong inter‑personal and people management skills. Strong project management skills. Strong collaborative skills and ability to work with a cross‑functional team. Technical/Functional (Line) Expertise Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go‑to colleague on a few topics Scientific understanding of drug R&D to inform methodological input with product team or in a platform Strong communication skills and ability to translate effectively across functional lines Ability to Identify and research new innovative approaches and leverage fit‑for‑purpose methods in to programs that he/she is involved in Leadership Lead one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D Enable the tactical execution of the SQS and DQS vision and mission Lead and be accountable for asset level strategies being implemented Demonstrate mentorship, matrix or direct management of small team of SQS colleagues Create an internal and external sphere of influence in area of expertise Education PHD with ~ 5 years experience MS with ~ 8+ years experience Behavioral Competencies Inspire teamwork Assess benefit risk of options Develop understanding of business beyond SQS Focuses on priorities 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: $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 Boston, 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. #J-18808-Ljbffr

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 Computational Oncology team drives innovation by transforming ‘omics and biomarker data into actionable insights that accelerate Takeda's Oncology pipeline. As part of the Precision and Translational Medicine organization, we collaborate across disciplines to decode complex datasets and shape strategies for personalized cancer therapies. Our mission is to improve patient outcomes by integrating cutting-edge analytics with translational science in a dynamic, purpose-driven environment. In this role, the candidate will collaborate with cross-functional teams to design and execute independent analyses using proprietary tumor datasets. They will integrate gene expression, protein abundance, and genetic mutation data to support precision medicine strategies. This hands-on experience offers the opportunity to contribute to personalized cancer treatment and make a meaningful impact on patient outcomes in a highly collaborative and innovative setting. How You Will Contribute: Collaborate with scientists across oncology, bioinformatics, and translational medicine, contributing to cross-functional research initiatives and gaining exposure to diverse perspectives in cancer research. Develop and apply innovative methods for integrating and analyzing multi-omics tumor data, using approaches such as statistical modeling and machine learning to uncover novel insights. Combine proprietary datasets with known biological pathways, networks, and interactions to explore mechanisms of treatment response and resistance. Identify molecular subtypes of cancers to support precision medicine strategies, including patient stratification and biomarker discovery. Design and execute your own integrative multi-omics analysis, tailored to your interests and experience, with guidance from experienced mentors. Internship Development Opportunities: Gain hands-on experience applying bioinformatics skills to high-quality proprietary datasets, contributing to real-world oncology research. Learn about the Oncology drug development process and discover how computational biology informs key decisions in precision medicine. Engage with leading industry professionals, gaining insights into the impact of your work and exploring career paths in translational science and the pharmaceutical industry. Job Requirements: This position will be Hybrid (1-3 days/week in office) out of the Cambridge, MA location Must be pursuing a Doctoral Degree in Computational Biology, Bioinformatics, Computer Science, or a related field Strong foundation in biology, chemistry, biochemistry, biostatistics, or a related scientific field Hands-on experience or coursework in bioinformatics, with exposure to transcriptomics, proteomics, or genetic mutation analysis Proficiency in R Interest in applying 'omics data to real-world healthcare and drug development challenges Clear and effective communication skills, with the ability to work well in cross-functional teams Strong analytical thinking and problem-solving abilities Ability to write clean, reproducible code and document analyses for collaborative research 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 thesetime frames Able to work full time 40 hoursa 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 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: Boston, 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypePaid Intern (Fixed Term) (Trainee) Time TypeFull time Job Exempt NoIt 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.

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 DescriptionAt 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. The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you. We are seeking a strategic, visionary Research Scientific Director to lead the next generation of AI/ML-enabled biologics discovery at Takeda. This senior leadership role has two primary mandates: Drive AI/ML application to accelerate and de-risk large-molecule pipeline projects Build and scale AI/ML platform capabilities as a core competitive advantage for biologics discovery. You will be a key leader within the AI/ML organization, setting strategy, building partnerships across R&D, and delivering measurable impact on our biologics portfolio. You will be accountable for converting state-of-the-art AI/ML science into validated, production-grade decision tools that change how Takeda discovers, designs, and optimizes large-molecule therapeutics. This role requires a leader who can operate at multiple altitudes, defining long-term vision and roadmaps while also ensuring scientific rigor, technical depth, and operational excellence in execution. Key Responsibilities 1. AI/ML Application to Pipeline Projects Drive the AI/ML strategy for antibody and other large-molecule discovery programs from target assessment through lead optimization. Ensure AI/ML activities are aligned with program and portfolio goals, with clear milestones, timelines, and success criteria. Deliver production-grade decision tools (for example, variant ranking, developability risk flagging, zero-shot design) that are seamlessly integrated into discovery workflows. Act as a hands-on technical leader across multiple programs: Define modeling strategies and architectures Prioritize methods and experiments Review and challenge scientific output for quality and robustness Partner with Discovery Platform Heads and project leaders to embed AI/ML milestones into program plans, stage-gates, and decision forums (discovery, engineering, mult-specifics) 2. AI/ML Platform Build and Innovation Define and own a multi-year platform roadmap for large-molecule AI/ML capabilities, including models, tools, data assets, and infrastructure. Lead the development and deployment of foundational models for antibody and protein sequence, structure, and function prediction. Drive integration of physics-based methods (for example, MD, FEP, docking) with machine learning approaches to create hybrid models with improved accuracy and generalization. Own data strategy for large-molecule AI/ML (data requirement, quality standard, governance) Partner closely with engineering, computational, and laboratory teams to ensure the platform is usable, reliable, and scalable across programs and sites 3. Leadership, Talent, and Culture Build, mentor, and retain a high-performing, multidisciplinary team of scientists and engineers. Provide clear goals, expectations, and development paths and ensure high standards of scientific excellence and reproducibility. Champion an inclusive, collaborative, and learning-oriented culture that values curiosity, rapid iteration, and rigorous validation. Communicate complex AI/ML concepts and results clearly to non-experts, including project teams and senior leadership, enabling data-driven decision-making. Qualifications Required: PhD degree in Computational Biology, Bioinformatics, Computer Science, or a related field with 10+ years relevant experience Proven track record of leading AI-driven projects in a research pharmaceutical setting. Significant depth of expertise in at least one field relevant to the job (for example, machine learning, biotherapeutic design, etc.). Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction. Significant depth of expertise in at least one relevant area, such as: Machine learning or deep learning Protein or biotherapeutic design Structural modeling or computational biophysics Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute both individually and through teams Versatile communicator who can explain complex ideas to non-specialists and influence diverse stakeholders Preferred: Experience leading teams that integrate machine learning with physics-based modeling (for example, MD, FEP, docking) Experience building or owning AI/ML platforms or foundational models used across multiple programs Prior leadership of cross-functional initiatives spanning discovery biology, protein engineering, and data or engineering teams ADDITIONAL INFORMATION The position will be based in Cambridge, MA. This position is currently classified as “hybrid” by Takeda's Hybrid and Remote Work policy 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: $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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women's Health. Our Vision is to build the leading Gastroenterology company in the U.S., with a complementary focus on innovation in Women's Health, premised on our expertise in pharmaceutical development and commercialization. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has its contract development and manufacturing organization (CDMO) in Holbrook, MA, offering pharmaceutical-development and in-house manufacturing services for specialty gastroenterology products. We value dedication, energy, and enthusiasm, and we focus on innovation and results while striving to achieve our corporate mission and vision. Sebela Pharmaceuticals is committed to cultivating an inclusive environment where all employees are treated with respect. We accomplish this by fostering a culture of diversity, equity and inclusion, which is essential to innovation and continuous improvement. Sebela operates from three locations in Roswell, Georgia, Braintree and Holbrook, MA and headquarters in Dublin, Ireland. The Validation Engineer is responsible for performing the necessary activities required to implement the Holbrook site's validation plan in compliance with current industry and regulatory expectations. This includes the creation and execution of Qualification and Validation documents and ensuing reports, and authoring cGMP documents. PRINCIPAL DUTIES AND RESPONSIBILITIES Manage qualification and validation projects from planning stages to completion. Create and execute Equipment Qualification Protocols (IQ/OQ/PQ). Create and execute cleaning and process validation protocols. Create and execute Computerized Systems validation protocols. Responsible for the development of documentation to support computer validation such as User/Functional Requirements specifications, Design Specifications and Risk Assessments. Troubleshoot validation issues to maintain the quality of the product and maximize efficiency. Support establishing resolutions and impact assessment for validation issues. Perform batch record and SOP revisions. Draft Incident and Deviation reports. Complete cGMP documentation and validation protocols accurately. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in Equipment and Utility Qualification, Process Validation, Cleaning Validation and Computerized System Validation. The requirements listed below are representative of the knowledge, skills and/or abilities required. Bachelor's degree or higher in Engineering, Life Sciences or related discipline. 3+ years relevant FDA regulated industry/validation experience or an equivalent amount of validation experience. Solid experience supporting/driving qualification and validation projects related to the pharmaceutical industry. Exceptional technical writing, review and analytical skills. Knowledge of good documentation practices and cGMPs. Must have strong ability to organize and manage multiple tasks in a fast-paced environment. Exceptional verbal and written communication skills. Auto CAD experience strongly preferred. Pay Range: $33.00 - $43.00 per hour (this reflects our reasonable and good faith estimate of what will be paid at the time of posting). Competitive benefits package included.

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 Are you looking for a patient-focused, innovative company that will inspire you and empower you to shine? Join us as Manager of Nonclinical Statistics in our Cambridge, MA office. As a Manager of Statistics, you will provide statistical leadership across Nonclinical functions. We seek a driven, inquisitive statistician, excited to use experimental design, advanced statistical tools, and decision theory to ultimately improve patient access to modern medicines. The remit of the successful candidate will span across both Chemicals, Manufacturing, and Controls (CMC) and focused areas of drug discovery with specific support to preclinical and clinical biomarker assay development and validation. For more information on CMC, click here, here, and here. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and by being a values-led company. We empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Provide statistical support and leadership for Takeda CMC campaigns for design and analysis in analytical development and formulation development for synthetic molecules, biologics, cell therapies, and other drug modalities. Provide statistical support and leadership for Takeda preclinical and clinical biomarker assay development and validation. Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality to explore methods and implement CMC strategies to enable data driven decision making. Apply frequentist, Bayesian, ML/AI fit-for-purpose statistical analyses across various projects and data types across the preclinical R&D arena. POSITION ACCOUNTABILITIES: Contribute to and/or serve as lead representing data science function on project teams in support of nonclinical studies throughout analytical development, formulations development, and other CMC functions. Develop and validate preclinical and clinical biomarker assays for all therapeutic areas. Perform end-to-end data analyses, from hypotheses formulation, experimental design, writing analysis plans, data cleaning, executing analysis, and preparing reports and documentation. Strengthen Takeda's advanced analytics toolkit by identifying and applying emerging techniques, as well as by developing novel analysis tools as needed. Collaborate effectively within a matrix environment, working with scientists across various areas to understand the problems in terms of its chemistry, biology, and/or physical natures and to tailor data analyses to program-specific needs. Work closely with Takeda statisticians to ensure statistical issues in data analysis are addressed. Communicate internal and external resource and quality issues that may impact deliverables or timelines of the program. Escalate issues to management as appropriate in a timely manner. Respond to regulatory questions that are statistical in nature. Increase the external recognition of Takeda's data science work by participating in conferences, publishing work and developing external collaborations. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education in a relevant field, for example a) PhD in a field such as Statistics, Physics, Electrical Engineering, Biomedical Engineering, Computer Science, Applied Mathematics with some relevant experience (including internships and research assistanceships), or b) Master's degree with a minimum of 3 years of relevant experience Hands on experience with and strong interest in some of the relevant fields of CMC and/or assay development and validation. Expert-level knowledge of data science programming languages (R, Python, or similar) and experience with recommended practices for software development. Ability to work independently on complicated datasets, including all aspects of data analysis (data cleaning, algorithm development, statistical analysis, and documentation). Excellent oral and written communications skills. Willingness and ability to self-educate in new areas. Knowledge of FDA, EMA, and ICH regulations and industry standards applicable to the CMC is a plus. This position is currently classified as “hybrid” in accordance with Takeda's Hybrid and Remote Work policy. 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 - Cambridge 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. LocationsUSA - MA - CambridgeWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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 Associate Director, Diagnostics Regional Medical Lead (DRML) is a field-based position that will provide liaison responsibilities supporting US Medical Diagnostics strategy across a specified geography. This role will collaborate with relevant business partners to provide input into the Medical Diagnostics strategy, with the primary responsibility of executing the Medical Diagnostic strategy with external stakeholders. The candidate will identify and develop on-going professional relationships with pathologists, testing labs, and key national and regional leaders in the diagnostic and biomarker areas in select oncology tumor types to improve patient identification for Daiichi Sankyo therapies. This territory includes: ME, NH, VT, NY, CT, RI, MA, PA, NJ, MD Job Description Responsibilities Scientific Engagement * Execute biomarker diagnostic readiness programs as defined by US Medical Diagnostics strategy (launch plans). * Execute field engagement strategy through facilitation of external engagements and by building relationships with key leaders in the diagnostic and biomarker area, including pathologists, testing labs, clinical experts and members of the MDT engaged in patient identification and education. * Establish and foster working relationships with CAP, USCAP, ASCP and regional pathology societies * Identify and build relationships with strategic partners, collaborating with internal stakeholders. Recommend and deliver diagnostics-focused educational content targeted to pathologists and KEEs in the diagnostic and biomarker areas. * Collaborate with US HEOR to identify external engagement opportunities related to biomarker evidence generation plans. * Drive dedicated pathology-centered trainings according to interpretation guides and ASCO/CAP guidelines; perform in person and virtual slide reviews. * Educate on clinical risk mitigation and impact of diagnostic choices on patient management. * Gather pathology and diagnostics -related external medical insights regarding DSI investigational products to help inform Clinical Development and US Medical Strategy. * Identify and build relationships with strategic partners, collaborating with internal stakeholders. Recommend and deliver diagnostics-focused educational content targeted to pathologists and KEEs in the diagnostic and biomarker areas. * Collaborate with US HEOR to identify external engagement opportunities related to biomarker evidence generation plans. * Drive dedicated pathology-centered trainings according to interpretation guides and ASCO-CAP guidelines; perform in person and virtual slide reviews. * Educate on clinical risk mitigation and impact of diagnostic choice on patient management. * Gather pathology and diagnostics-related external medical insights regarding DSI investigational products to help inform Clinical Development and US Medical strategy. * Respond to unsolicited requests for medical information and compliantly collaborate with DS field teams Strategic Planning and Project Management: * In alignment with US Medical Affairs Plans, provide input into the Field Medical Diagnostics strategy, including tactics, performance measures and resources. * Inform the US Medical Diagnostic strategy, for current and future oncology products, through timely insight sharing from pathologists and KEEs in the diagnostics and biomarker areas. * Conduct/Prepare regular business reviews aligned to overall US Medical Diagnostic strategy and DRML performance metrics/objectives to maximize regional planning and execution. * Collaborate with relevant internal business partners (e.g., HEOR, MVL) to assist with design and execution of HEOR studies, outcomes surveys, etc. related to diagnostics. * Assist in identifying solution-based strategies to address biomarker adoption, barriers, and gaps. * Lead special projects/initiatives, as needed, in support of US Medical Affairs diagnostics strategy. _Strategic Representation & Operational Governance: * Provides leadership presence and advocacy by representing FMA Leadership at key organizational meetings, functions, and events to ensure alignment with strategic priorities. * Oversees critical administrative governance activities, including expense management and field activity reporting, to maintain compliance and operational excellence. Responsibilities Continued Qualifications Education Qualifications * Bachelor's Degree required * Advanced scientific degree (PhD, PharmD or MD) preferred; equivalent will be considered with relevant experience in diagnostic and biomarker area Experience Qualifications * 7 or More Years overall related experience or commensurate education/experience (with at least 5 of the 7 being relevant, professional experience) required * 4 or More Years of related work experience in industry, clinical, or research institution with emphasis in oncologic pathology required * Demonstrated business acumen, including understanding of drivers behind evolving diagnostic landscape * Strong analytical and problem-solving skills while demonstrating strategic thinking, leading, and delivering outcomes * Deep understanding of diagnostic FDA environment, clinical laboratory practices including CAP/CLIA lab requirements and test implementation * Proven track record of strategic thinking, judgment, and influencing skills * Ability to work independently in a remote environment with moderate supervision * Strong knowledge of clinical diagnostic development, and Field Medical activities * Clear demonstration of effective cross-functional project team collaboration * Proven ability to interact productively with both commercial and scientific / medical colleagues * Experience in engaging with external experts * Exceptional teamwork and collaboration skills * Excellent written and oral communication, interpersonal, and organization skills * Experience working in, or with, US pathology laboratory preferred Travel Requirements * Ability to travel up to 60% of the time, including overnight. 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$206,800.00 - USD$310,200.00 Download Our Benefits Summary PDF

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. The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives and help shape how AI delivers real impact in drug discovery, we'd like to hear from you. Objective / Purpose: We are seeking a skilled and motivated Scientist to join our Large Molecule AI/ML team within Computational Sciences. This role focuses on developing and applying machine learning methods to accelerate antibody discovery and optimization on active pipeline projects. You will work closely with protein engineers, computational scientists, and experimental teams to deliver predictive models that directly impact candidate selection and developability assessment. The ideal candidate combines strong ML fundamentals with an interest in biologics and thrives in a fast-paced, collaborative R&D environment. Accountabilities: Develop and implement machine learning models for antibody property prediction, including developability attributes (stability, aggregation, immunogenicity, viscosity) to support active discovery programs. Build predictive tools that rank antibody candidates, flag potential liabilities, and suggest sequence modifications for improved properties. Benchmark and evaluate external computational methods and commercial AI platforms; recommend best-in-class tools for integration into internal workflows. Innovate, develop, and apply predictive models for protein design and developability engineering, utilizing large-scale NGS, in vitro, in vivo and other proprietary in-house and external data sources. Investigate transfer learning and few-shot learning approaches to enable rapid model deployment on new antibody formats (multi-specifics, VHH, ADCs) with limited training data. Collaborate with experimental teams to validate predictions against assay data, iterate on model development, and integrate AI/ML outputs into Design-Predict-Make-Confirm cycles. Establish and maintain AI performance dashboards and KPIs to track prediction accuracy, model reliability, and impact on project timelines. Stay current with advances in machine learning for protein science and contribute to internal knowledge sharing. Education & Competencies (Technical and Behavioral): Required: PhD in Computational Biology, Bioinformatics, Computer Science, or related field, OR MS with 6+ years relevant experience, OR BS with 10+ years relevant experience. Proven track record in developing machine learning models for biological or chemical data. Proficiency in Python and machine learning frameworks (PyTorch, TensorFlow, or scikit-learn). Experience with protein sequence analysis and understanding of antibody structure-function relationships. Strong analytical and problem-solving skills with demonstrated ability to work both independently and collaboratively. Excellent communication skills to convey complex computational concepts to diverse scientific audiences. Preferred: Experience with protein language models (ESM, ProtTrans) or other deep learning architectures for protein property prediction. Familiarity with antibody developability assessment (stability, aggregation, immunogenicity). Experience with transfer learning or active learning approaches. Prior experience in pharmaceutical or biotech R&D environment. Experience with cloud computing (AWS, GCP) and version-controlled ML pipelines. Additional Competencies Common in Strong Candidates Ability to lead cross-functional initiatives and mentor junior scientists. Experience in translating computational insights into experimental strategies Strong publication record or demonstrated thought leadership in AI for biology and molecular design. Comfort working in fast-paced, innovation-driven environments with evolving priorities. 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: $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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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: 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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities-including small molecules, biologics, and external manufacturing sites-the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes. We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. How you will contribute: * Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements. * Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes. * Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities. * Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions. * Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics. * Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. * Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale. * Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings. * Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact. * Promote sustainable practices and scalability in site-level regulatory operations. Minimum Requirements/Qualifications: * BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. * 10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. * Strong practical experience with global HA requirements, beyond EU/US. * Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. * Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. * Analyze issues with attention to detail. * Ability to assess alternative approaches. * Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines. * Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. * Understands who is responsible for different decisions and escalates as necessary. * Applies directions taken by the company. * Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. * Intentionally promotes an inclusive culture. * Applies given prioritization framework with limited support. * Excellent written and oral communication skills required. * Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork. 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. This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 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: $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 Boston, 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.

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 Manufacturing Lead Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands . Oversees floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained. Ensure efficient use of material and equipment and assign personnel in the execution of daily operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices into manufacturing. You will report to Manufacturing Supervisor. How you will contribute: Primary contact for troubleshooting, issue resolution or escalation; create and follow up on work orders; communicate daily scheduling and staffing plans, including reallocation of staff for breaks, lunch, and training. Provide oversight and execution of all routine and critical operations, including commissioning and validation activities; monitor material consumption and coordinate all material deliveries. Ensure documentation (forms, logbooks, form preps, batch records) is complete, reviewed, and meets good documentation practices; communicate schedule changes as needed; responsible for floor inventory. Recommend and implement process changes/improvements and safety or ergonomic improvements; ensure work is carried out safely, reporting safety issues and risks. Initiate deviations or investigations of various complexities; work with cross-functional teams to identify root causes, implement corrective actions, and complete GMP investigation/CAPA action items. Assist supervisor, engineer, or facilities with investigations; revise and author SOPs and batch records; communicate any quality issues or concerns to Supervisor and QA. Responsible for interviewing candidates; provide performance feedback; address minor personnel issues promptly and escalate major issues to the supervisor. Ensure staff compliance with relevant SOPs, batch records, form preps, and safety guidelines; act as a role model, subject matter expert (SME), and resource for staff; ensure safe work practices and behaviors. What you bring to Takeda: Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience. Biotech Certificate and prior leadership experience would be ideal. Experience with systems such as SAP, LIMS and TrackWise would be ideal. Perform manufacturing and sampling operations using aseptic technique Operational knowledge of Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters etc. Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department. Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure. In the absence of the supervisor they are the person of authority. Expected to act on behalf of the supervisor while on the floor Prior experience or exposure to standardization and measurements utilizing bench top equipment, aseptic processing, cell culture inoculation and scale up processes, use of bioreactors and centrifuges in the growth of cell cultures, process automation and SAP Enterprising Resource Platform. 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. Flexibility to work according to the production schedule. Ability to lift, pull or push equipment requiring up to 25-50 lbs of force. Ability to stand for 6 hours in a production suite. Ability to climb ladders and work platforms. Stooping or bending to check or trouble-shoot equipment operations. Ability to work around chemicals (alcohols, acids & bases). 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: $27.60 - $43.37 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 - MA - Lexington - BIO OPSWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt NoIt 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.

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 a member of Takeda Oncology, your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Global Health Economics team, you will report to the Head of Global Health Economics and US HEOR. * Drive and realize value demonstration strategies for Takeda's global oncology portfolio, achieving rapid, broad patient access and delivering differentiated, evidence-based pricing through best-in-class health technology assessment (HTA; including the EU Joint Clinical Assessment [JCA]) and payer decision outcomes. Lead cross-functional integration and impact, resulting in accelerated market access, measurable commercial performance, and sustainable advantage across various assets and indications worldwide * Lead the strategic development, execution, and continuous optimization of global health economics (HE) plans, reimbursement strategy, and evidence communication. Build and deploy best-practice tools and training to maximize adoption and impact of global HE deliverables across all regions * Mobilize and align cross-functional and cross-regional stakeholders at all enterprise levels, including R&D, Market Access, and local operating companies (LOC), to ensure seamless integration of evidence requirements and accelerate value realization for patients and payers * Co-lead the vision, development, and adaptive evolution of enterprise-level frameworks (e.g., Integrated Evidence Generation Plans [EGPs]), ensuring that all evidence and access strategies are fully aligned with evolving payer, HTA, and policy needs globally * Pioneer and implement innovative digital, data science, and AI-driven health economics and outcomes research (HEOR) approaches, actively shaping Takeda's future market access strategy. Influence enterprise-level decision-making and mentor emerging leaders through formal educational and strategic thought leadership programs * Advance Takeda's global reputation and influence by proactively shaping thought leadership at international and industry forums, policy discussions, and leading scientific consortia-building strong partnerships with HTA, payer, academic and clinical stakeholders, and elevating Takeda's position as a recognized leader in HE and value demonstration How you will contribute: Global Value Proposition: * Drive and deliver differentiated, evidence-based global HE value propositions resulting in best-in-class HTA/payer decisions, accelerated market access, and sustainable competitive advantage across the oncology portfolio. Anticipate and capitalize on emerging payer and societal needs * Direct and oversee the co-development with Global Pricing, Value & Access (PVA) and cross-functional leaders to build compelling, evolving value narratives that impact payer decisions and drive optimal patient access worldwide * Drive strategic identification and prioritization of high-value opportunities-including new indications, lifecycle extensions, and innovative contracting models-across the portfolio Evidence Generation: * Provide enterprise-wide vision and impactful leadership in evidence generation to secure HTA, payer, and market access objectives, integrating payer and real-world data needs across global, regional, and local programs * Pioneer new approaches, including digital, data science, and AI, to transform evidence generation and proactively shape Takeda's response to dynamic global value trends * Review recommendations for advanced evidence needs (e.g., RWE, patient-centered outcomes), ensuring that internal and external partners are aligned to address emerging payer trends and requirements. * Lead the incorporation of innovative and payer-relevant endpoints in clinical development strategies and ensure robust HTA (including JCA) readiness HE and Value & Access Tools * Set enterprise-wide benchmarks for scientific rigor in HEOR studies; ensure continuous innovation, external credibility, and differentiation with HTA bodies and payers * Drive the implementation of global HE strategies and tools (Value Platforms, Dossiers, value-based contract [VBC] toolkits) and ensure consistent capability build across regions and LOCs, directly spearheading global rollouts and advanced training programs * Co-lead the conceptualization and execution of VBC options in collaboration with Market Access and Pricing, assessing and advancing their commercial impact * Continuously advance all HE and Market Access tools in response to dynamic evidence and payer environments Market Access: * Serve as enterprise expert and spokesperson for Takeda's global product value proposition-proactively engaging, influencing, and shaping both HTA policy and payer decisions to safeguard and expand market access opportunities * Monitor and anticipate trends in the global HTA/reimbursement landscape to guide, shape, and transform Takeda's HE and access strategies at the enterprise level Communication/Publication: * Elevate Takeda's visibility and reputation through global HEOR communications, policy publications, and leading contributions to industry discourse * Lead global communication strategy, translating complex technical analyses into actionable, compelling value stories for executive, payer, and policymaker audiences Foster Superior Collaboration: * Mobilize, empower, and align cross-functional and external networks to deliver enterprise-wide HEOR and Market Access innovation. Facilitate global knowledge sharing, mentoring, and continuous capability-building * Cultivate and manage advanced collaborations with HE opinion leaders, vendors, and academic partners to ensure Takeda remains at the forefront of innovation and excellence in health economics Basic Qualifications/Requirements: * Doctorate with 7+ years of experience, Master's with 9+ years of experience or Bachelor's with 12+ years of experience in healthcare industry with direct experience in global product value proposition development (industry or consulting) and interaction with payers, HTA bodies, relevant policymakers and strong patient-centered focus * Robust understanding of the global payer environment and in-depth understanding of ex-US payer landscape including HTA trends and guidance (e.g., NICE, CADTH, PBAC, EU JCA), along with knowledge of US Medicare (Part D), ICER in the US and trends in Emerging Markets (e.g., China) - including reimbursement methodologies, pricing/reimbursement authorities' decision-making process and current reimbursement issues * Strong knowledge and hands on experience in health economics, health technology assessment (HTA) tools, methods and filings, SLRs, ITCs, statistical analyses and economic modelling * Strong knowledge and understanding of clinical and epidemiological information, innovative global pricing models, all phases of drug development methods of analysis of large databases (e.g., claims data, electronic health records) and the major areas of Outcomes Research (PROs, modelling) * Leadership - strong ability to work in a highly matrixed organization * Strong analytical capabilities and excellent communication skills (written and oral) * Strategic thinking and demonstrated problem solving capability * Influencing skills (one on one and in group setting) - consensus builder with ability to effective drive decision making * Ability to translate technical issues to non-technical experts * 5 to 10% Domestic and/or International travel may be required PREFERRED QUALIFICATIONS: * Previous experience in Hematology and/or Oncology * A combination of in-depth knowledge of Global HTA (including EU JCA) requirements and direct experience in HTA submissions * Direct payer experience and/or experience in Market Access * Track record of peer-reviewed publications 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. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy 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: $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 Boston, 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.