Sarepta Therapeutics jobs in Andover, MA - 143 jobs

A leading biotechnology firm is seeking a Clinical Imaging Scientific Director for Oncology to lead imaging strategy and execution in clinical trials. The ideal candidate will have a PhD and over 10 years of experience in clinical imaging, particularly in oncology, with significant expertise in PET imaging and regulatory engagement. This role requires collaboration with research teams and overseeing imaging project implementation, contributing significantly to oncology drug development. Comprehensive benefits are offered to eligible employees. #J-18808-Ljbffr

Project Management & Strategic Operations Director page is loaded## Project Management & Strategic Operations Directorlocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27588**Job Description****General Summary:**The Project Management & Strategic Operations Director - Clinical Development serves as the end-to-end program lead for large-scale strategic programs of high business value. Drives benefit achievement by leading program initiation, planning, solution design and build, and by measuring key performance indicators and solution adoption. Engages other colleagues/resources and assigns appropriate responsibilities to support achievement of program roadmap and project plan(s). Independently applies expert knowledge of advanced methodologies, selecting and applying high-level project management tools to conduct analyses, reporting and related activities for assigned projects. Contributes to the development of internal protocols and processes used to carry out program management work. Responsible for program management activities including contingency/dependency tracking, status reporting, issue/risk identification and tracking, scope management, estimation, and internal/external stakeholder management. Provides oversight to workstream/task leads within the program; resolves any escalated project risks, issues and dependencies. Manages the overall scope and timing of the program, ensuring on-time and within budget delivery.This role will serve an important role in the Global Clinical Development organization to improve focus and alignment across programs and ensure greater organizational effectiveness. Responsibilities will include working with other functions within Vertex to obtain accurate, up-to-date plans and metrics across all clinical development programs to ensure visibility and alignment, including study milestones, enrollment metrics and budgets.**Key Duties and Responsibilities:*** Organizing, driving and managing the Clinical Development deliverables in terms of timelines, budget and communication.* Serve as a strategic partner to the SVP, Clinical Development; create and run reports, create presentations, draft communications documents, serve on cross-functional strategic initiatives representing Clinical Development.* Support the SVP, Clinical Development in creating, communicating and tracking annual goals* Partner with Clinical Development Execution group to use the clinical operations systems to track study enrollment across programs vs target and translate the information to make it relevant and user friendly for Clinical Development.* Work with finance, clinical development execution team and medical directors to track study budgets across programs vs target* Collaborate with regulatory team to use the regulatory systems to track upcoming regulatory meetings and briefing documents (drafts/review schedule etc) and translate to make this information to make it relevant and user friendly for Clinical Development* Run the TA review meetings including meeting minutes, tracking and archiving submissions and decisions* Drive executional excellence in terms of timelines, sign-offs, submissions to internal governance (eg protocols, CSRs, etc) and external postings like clinical trials.org* Support onboarding, compliance/SOP training and tracking, team effectiveness* Lead communications within the Clinical Development team including updates within the team, to cross-functional partners including those ex-US, and bring relevant communications from the broader organization in to ensure the Development area are aware and prepared* Oversees end-to-end program management activities for large-scale, strategic programs of high business value, with oversight for the full project lifecycle* Manages the progress and contributions of workstream leads or subordinate project managers to ensure all activities deliver expected value within committed timeframes and budget* Manages contingencies between multiples projects and monitors interdependencies and synergies where required* Builds and synthesizes highly-detailed project plans, budgeting & forecasting models or resource plans, requiring significant stakeholder management skills and interpretation of diverse and varied information* Develops statements of work, stakeholder management plans, guiding principles, project goals, risks, resource allocation, and roles and responsibilities for assigned projects* Secures, leads, motivates and inspires the internal and external resources required to effectively deliver the program. Establishes the program's governance (e.g., sponsors, approvers, stakeholders)* Participates in the evaluation, selection and management of external resources or vendors* Provides transparency in project progress and effectively anticipates and mitigates major risks across the project lifecycle* Proactively crafts feasible solutions to combat risks and issues. Exercises sound judgement balancing risks and making prompt decisions in ambiguous or difficult situations* Manages communication with management at a detailed functional level and discusses/resolves issues* Works with all required functions and groups to effectively plan and execute the program/project(s). May coordinate resources across organizational boundaries* Trains and coaches project teams in execution methodologies and promotes adoption of best practices* Develops tools and training methods to enable successful project management throughout the enterprise. Ensures project delivery is in conformance with company methodologies and standards; recommends improvements and changes as necessary* Evaluates program costs and benefits including actual results and forecasts with comparisons to original or baseline plan and updates plans with accurate, up-to-date information in a timely manner. Reports financial information and status to leadership. Ensures program solution(s) meets quality and reliability requirements and that the launch approach meets or exceeds adoption targets. Monitors program results/performance for significant deviations, evaluates options and makes recommendations for corrective actions, and then implements selected actions**Knowledge and Skills:*** Some education, training or experience in biology/chemistry/engineering desirable* Drug Development knowledge and/or project management experience preferred* Proven experience in cross-functional execution including medium to large-scale projects* Critical thought partner and proven ability to connect people and ideas to drive outcomes* Demonstrated ability to connect with over divisions and functions throughout Vertex* Ability to manage multiple priorities/projects at a given time, ensuring deadlines, budgets and status updates* Highly developed communication skills and the ability to synthesize data and information into meaningful insights* Very detail oriented and strong project/operation management skills* Ability to handle ambiguity**Education and Experience:*** Bachelor's degree* Typically requires 10 years of experience or the equivalent combination of education and experience**Pay Range:**$183,800 - $275,700**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. #J-18808-Ljbffr

Senior Medical Science Liaison - Nephrology (Missouri/Iowa/Nebraska/ Illinois: South/Central) page is loaded## Senior Medical Science Liaison - Nephrology (Missouri/Iowa/Nebraska/ Illinois: South/Central)locations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-26673**Job Description****General Summary:**The Senior Medical Science Liaison (Sr MSL) (Nephrology) for Povetacicept programs. Povetacicept (pove) is an enhanced, dual BAFF/APRIL inhibitor in pivotal development for the treatment of IgA Nephropathy (IgAN).The Sr MSL will serve as a scientific liaison to the medical/academic community and is responsible for establishing and maintaining relationships with Health Care Providers/Professionals (HCPs) to ensure the appropriate dissemination of clinical and scientific information regarding Vertex' compounds in a timely, ethical and stakeholder-focused manner. The Sr MSL will contribute to shaping the medical plan by providing external stakeholders' insights and contribute to the designing and execution of the Medical Affairs strategy and plan. The Sr MSL will engage HCPs in response to scientific educational and research needs with available Vertex resources and provide the latest emerging data in response to specific inquiries, as appropriate.**Key Duties and Responsibilities:*** Develops and fosters effective and trusting relationships with Thought Leaders (TL) and identifies and engages other appropriate HCPs resulting in scientific engagement with a large network of T1D and transplant-team care providers and opinion leaders. Additionally, understands the inter-relationships both within and between academic centers and utilizes this expertise to enhance Thought Leader and HCP engagements* Consistently incorporates all aspects of the SEM (Scientific Engagement Model) into all interactions, enhancing the quality of interactions and overall relationships as assessed by field coaching observations* Independently incorporates the medical plan into interactions and territory planning (i.e. listening priorities) and captures valuable feedback in the CRM system to inform internal stakeholders and assist in shaping the medical strategy* Possesses an in-depth understanding of the utility and functionality of the CRM system/data analytics tools, allowing for the time sensitive capture of interaction details. Uses CRM/Analytics to enhance future TL engagements and manage workload* Discusses scientific information effectively and compliantly with external stakeholders at an advanced level of communication for both disease state and product to external stakeholders as assessed by management coaching and field observations* In-depth conceptual and practical knowledge of payers in the region and possesses an in-depth understanding of the impact of payers on patient care delivery* Assists clinical development/clinical operations by fully understanding IB content and presenting IB material, providing nominations for trial sites as requested, providing end of study data reviews with investigators (as needed)* Represents Vertex at medical congresses by providing scientific session/abstract coverage, booth staffing coverage, routine TL interactions, contributing to the daily and end of congress summaries and may provide logistical guidance through organizing and scheduling abstract/session coverage and preparing and delivering the conference debrief (as needed)* May serve as a mentor or trainer for colleagues with less experience; for example, assisting with new hire MSL onboarding* Conducts all activities in compliance with Vertex policy and procedures and performs all administrative tasks in a timely manner such as CRM entry, vehicle mileage reporting, expense reporting, calendar entries, training assignments, etc.**Knowledge and Skills:*** Ability to complete goals within allotted timeframes, and deliver high quality results* Ability to help plan and complete projects in a constantly changing field-based environment* Ability to appraise and comprehend medical and scientific literature* Ability to effectively present clinical/scientific information in a credible manner in varied settings* Good knowledge of assigned geographic territory* In-depth understanding of healthcare regulatory environment* Apply proficient knowledge of relevant T1D and T1D management protocols, healthcare environment and landscape to articulate the medical and scientific value of our products* Demonstrated working understanding around the compliance and regulatory frameworks that govern the pharmaceutical industry and conducts compliant interactions with internal and external stakeholders.* In-depth knowledge of payers and unique medical information needs to support access and appropriate use of Vertex medicines* Good knowledge of Health Economics and Outcomes Research* Fluent in English (oral and written)**Education and Experience:*** Minimum requirement for advanced biomedical or life sciences degree (ex. Masters, NP, PA)* Requires minimum of 3-4 years of experience as an MSL supporting Nephrology programs or in other medical affairs roles in the pharma/biotech industry or the equivalent combination of education and experience.* Previous training or experience in designated therapeutic area is helpful Pay Range:$171,300 - $245,000Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. #J-18808-Ljbffr

A leading biotechnology company is seeking a Senior Director for Global Medical Affairs in Nephrology. This role involves providing medical and scientific leadership, developing medical affairs plans, and ensuring compliance with regulatory standards. A terminal scientific degree and 11 years of relevant experience are required. The position offers a salary range of $240,000 to $360,000, hybrid work arrangements, and various employee benefits including paid time off and educational assistance. #J-18808-Ljbffr

A global biotechnology company is seeking a Director of Downstream Process Development in Boston. This role requires advanced leadership skills and expertise in biologics, overseeing the development and optimization of therapeutic biologics with responsibilities in both technical and regulatory aspects. Candidates should have extensive experience with chromatography systems and drug substance development, ensuring compliance with quality standards. Competitive salary range is $195,500 - $293,200, and this is an on-site position. #J-18808-Ljbffr

A global biotechnology company is seeking a Commercial Supply Chain Associate Director to lead the Sales and Operations Planning for Casgevy. This role involves working effectively with cross-functional teams, establishing key assumptions, and overseeing performance indicators. The ideal candidate will have at least 8 years of experience in supply chain management, preferably within the cell and gene therapy field. This position is eligible for a hybrid work model, offering flexibility in workplace arrangements. #J-18808-Ljbffr

A leading biotechnology company in Boston is seeking an Associate Director, GMP Operational Quality to ensure compliance and quality oversight for commercial drug manufacturing. The role includes managing relationships with vendors, mentoring team members, and leading quality improvement initiatives. Candidates should possess strong knowledge of cGMPs, a scientific degree, and extensive experience in quality assurance and project management. This position offers a hybrid work model and competitive compensation package. #J-18808-Ljbffr

A global biotech company is seeking an Associate Director for Strategy and Operations in Boston. This role supports the US Market Access Leadership Team, driving strategic initiatives and operational execution. The ideal candidate will have over 8 years of experience, strong communication and collaboration skills, and a Bachelor's degree. The position offers a hybrid or on-site work model and competitive compensation ranging from $155,700 to $233,600 annually, with additional benefits such as educational support and paid time off. #J-18808-Ljbffr

About this opportunity : In this position you will support day-to-day QA Operations activities such as batch record review, release of raw materials, review of AA and HVAC reports, customer corrections and following cGMP practices and guidelines. This role serves as a key quality interface between operational teams and quality oversight functions. Key Responsibilities: Review and verify raw material documentation (e.g., Certificates of Analysis, Certificates of Compliance, and material specifications) for compliance with internal and regulatory requirements. Responsible for reviewing, approving, scanning, and binding quality records/batch records, and raw materials records. Responsible for knowledge of SAP system for release/rejection of raw materials. Maintains spreadsheets for the review cycles of quality documents. Interact /communicate with various department such as Manufacturing, Supply Chain and Quality Control. Coordinate corrections for quality documents internally and externally (e.g., client comments) Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections. Attend daily QA meetings. Support Senior/Lead Specialists. Gather/support corrections, quality metric reports to executive management. Provide strong link/communication between the QA function/activities with all other departments at the Milford site. Support Material Review Board (MRB) and labeling of raw materials (as required). Support Raw material re-evaluation process. Assist in customer documentation requests. Perform walk-through of manufacturing suites (as required). Help with internal audits of all GMP departments. Assist in deviation and investigation follow-up by coordinating data collection and document retrieval. Contribute to inspection readiness activities, document control harmonization, and trending initiatives in collaboration with QA Systems. Actively participate in continuous improvement efforts related to QA operations, document lifecycle management, and process ownership. Required Skills/Abilities: The job requires a BS/BA in science or equivalent work experience of at least 2 years' experience in either Production or Quality Assurance. Provide sound decision-making and guidance on all aspects of batch record review and raw material release. Provide strong link/communication between the QA Operations and QA Projects Departments. Interface with Manufacturing, QC, Warehouse, and Supply Chain to ensure timely and compliant material release and disposition activities. Must be able to gown up and enter Manufacturing suites. The annualized salary for this position is $65,600.00 - $79,800.00.

A leading biotechnology company is seeking a Director of Digital Marketing to drive engagement for their kidney portfolio. You will develop omnichannel strategies, collaborate across teams, and leverage data insights to enhance brand impact. Ideal candidates will have over 10 years in pharmaceutical marketing and proven success in digital campaigns. This position offers a hybrid work option and competitive compensation according to skills and experience, along with extensive benefits. #J-18808-Ljbffr

A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr

Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you'll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We're passionate about innovation, inclusion, and supporting your growth-inside and outside the lab. Why Vertex? Real Projects: You'll work on assignments that make a real impact, not just busy work. Mentorship & Networking: Connect with leaders and peers who want to see you succeed through professional networks, connections, and collaborations that will shape your longer-term career. Flexible & Supportive: We offer flexible work options with Flex @ Vertex and prioritize your wellbeing. Inclusive Culture: Collaboration and inclusion are embedded in everything we do. Career Launchpad: Build skills, explore career paths, and get guidance for your future career. Ready to apply? Submit your application and let's turn possibilities into reality! Your Impact The Vertex Research internship program is a multi-week experiential training program for students currently working towards an advanced degree in Applied Mathematics, Computational Biology, Pharmaceutical Sciences, Chemical Engineering, or a related field of study. If you are passionate, collaborative, and growth-minded, an internship at Vertex will help you gain meaningful experience in our Drug Metabolism Pharmacokinetics functional areas and serve as a launchpad for your career. Important Notice Regarding Internship and Co-op Inquiries At Vertex Pharmaceuticals, we are committed to providing a fair and structured recruitment process for all students interested in internship and co-op opportunities. To ensure consistency and equity, all student applications must go through our Early Talent Acquisition Team. Due to the high volume of interest, we are unable to respond to individual solicitation. Direct solicitation to Vertex employees- including senior leaders via email will result in removal from the recruiting process. We appreciate your enthusiasm and interest in Vertex. To be considered for internship or co-op roles, please apply directly through our official application channels. (************************************************************************** Thank you for respecting our process and helping us maintain a fair experience for all candidates. What you will be doing: The Preclinical Modeling and Simulation (pM&S) team within the DMPK department uses mathematical models and computational tools to predict, optimize, and quantify the absorption, distribution, metabolism, and excretion of drug candidates. This intern position will work with the pM&S team to develop mechanistic and systems-based models of diseases for translational research purposes. Develop and implement quantitative systems pharmacology (QSP) models of relevant diseases in collaboration with the pM&S team Source modeling techniques and approaches from literature sources or design novel models as necessary to address questions and inform decision making across programs Collect relevant data from published sources as necessary for model calibration Present and discuss research progress with the pM&S team, DMPK, and other stakeholders as appropriate What you will need to succeed: Enrolled in a graduate program, majoring in Applied Mathematics, Computational Biology, Pharmaceutical Sciences, Chemical Engineering, or a related field of study. Significant experience (2-4 years minimum) using a programming language such as Matlab, Python, R, or Julia to numerically solve systems of ordinary differential equations is required for this position Experience designing and implementing ordinary differential equation-based models of biological systems, including parameter optimization using time-series data Experience importing, processing, and visualizing data using one of the programming languages listed above History of publication and/or conference presentations in mathematical biology, quantitative pharmacology, or QSP Knowledge of pharmacokinetics (PK), pharmacokinetic-pharmacodynamic (PKPD) modeling, QSP, population pharmacokinetics (pop PK), or graduate coursework in applied mathematics is desirable but not required Knowledge of modeling softwares commonly used in the pharmaceutical industry such as Phoenix WinNonlin, SimBiology, SimCyp, or MonolixSuite is desirable but not required Expertise in at least one specific disease area is desirable but not required Legal authorization to work in the United States, now and in the future. Please note that Vertex does not provide sponsorship for internships or entry level roles within this part of the organization. You must be enrolled in an advanced degree program if graduating before August 2026 You must be available to work full-time, 40 hours per week from May - August 2026 Program Details: Full-time, paid internship $26.00 - 35.00 USD/hour Program Dates: May - August 2026 At Vertex, we believe that when you feel your best, you can perform at your best. That's why our US benefits and global well-being resources are designed to support you. • Free 24/7 onsite gym access and free access to group exercise classes • Subsidized commuter benefits- transit and parking • Provided meals-free breakfast daily! • Career development opportunities and events, including C Suite engagement • Social events-both intern-only and company-wide • Location-specific perks and extras! • Recognition of National Intern Day Equal Opportunities Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Vertex is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accessibility & Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Vertex is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role, Vertex is unable to sponsor non-U.S. persons to apply for an export control license. This job posting is for a temporary role with a third-party agency partner that provides services to Vertex. The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer. For any questions or concerns, please contact early_***************. Pay Range: $0 - $0 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

A leading biotechnology company is seeking a Director, Global Process Excellence to enhance finance systems and processes integral to scaling operations. This role requires extensive finance experience, capability in project management, and leading cross-functional improvements. The position offers a hybrid work model and competitive salary range of $180,800 - $271,100, along with generous benefits and annual bonus eligibility. #J-18808-Ljbffr

About this opportunity : As a Manufacturing Technician II, you'll be responsible for the implementation of assigned production operations working within defined production schedules in a cGMP environment.This is a 2nd shift position and comes with a 15% shift differential. Key Responsibilities: Maintain a clean and organized work environment. Responsible for following GMP and safety cultures, procedures, and regulations. Identify and submit safety hazards and incidents. Complete GMP documentation in a compliant manner. May review less complex documentation like logbooks. May revise procedures under direct supervision. May participate in investigations. May execute CAPA tasks. Identify and implement small continuous improvement projects. Responsible for assigned production activity and ensuring training is compliant prior to performing operations. Problem solving: basic understanding of process and documentation. Ability to identify abnormal results and report to higher position. Proficient in the assigned area of the process. Required Skills/Abilities: Minimum education requirements: high school diploma or equivalent with college level Chemistry degree or equivalent work experience. A biotechnology certificate or college degree is preferred. Must have knowledge of basic laboratory instrumentation such as use of pH meter, UV instrumentation, and solution delivery systems (process skids). Two plus years of experience in cGMP manufacturing environment. Performance/other experience can be considered pending manager discretion. The annualized salary range for this roles is $61,700.00 - $75,600.00.

Associate Director, Cell & Gene Therapies External Manufacturing Operations - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (based in US, New England) The primary focus of the Associate Director, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located either at the cell and gene therapy CMO's site and/or be able to travel up to 50% of their time to those sites as a "Person-in-Plant" to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. Key Responsibilities: * Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs) * Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management); be Vertex's "eyes and ears" at the CMO for right-first-time execution of commercial operations. * Proactively "connect the dots" on emerging trends and issues and lead/influence cross functional teams to drive resolutions and minimize impact to compliance and delivery of safe and reliable supply * Maintain on-site presence at CMO facilities for extended periods (including off hours/weekends) to oversee (i) critical program activities, (ii) clinical and commercial batch manufacturing until the CMO is sustainably executing operations, and (iii) Health Authority inspections. * Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. * Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities including but not limited to (i) contract management (including tracking KPIs and metrics e.g. for batch release, inventory targets and schedule attainment), (ii) forecast communication and schedule alignment, (iii) supplier governance (including Vertex Quality/other audits) and (iii) finance (e.g. issuance of POs and reconciliation/validation of invoices; tracking of spend vs budget). * Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing. * Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization. * Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements. * Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain, CMC, and Quality leadership. * Collaborate with CMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments. * Lead continuous improvement initiatives to affect timely resolution of supply issues. * Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders. Minimum Requirements: * Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role working with or in cGMP facilities within the biotechnology industry. * Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations. * Strong technical background in aseptic manufacturing operations. * Solid project management skills and experience managing complex projects. * Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience. * Strong leadership and an innate ability to collaborate and build relationships is critical. * Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change * Flexibility to work shift hours required to cover critical process steps * Ability to travel, national and international, up to 50% * Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces and electronic quality systems Desired Additional Skills: * Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. * Solid experience in equipment and facility qualification and validation for ATMP CMO's * Cleanroom qualification (Grade A/B) history Environment: * Office and cleanroom - must be able to comply with cleanroom gowning requirements at CMO * Must be able to remain in a stationary position 50% during cleanroom processing activities * Must be comfortable moving about inside the cleanroom to oversee process tasks * Compressed gasses and LN2 are commonly used in manufacturing operations * Human tissue (e.g. apheresis) and cellular materials are commonly used Pay Range: $160,000 - $240,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

A global biotechnology firm is seeking a Technology focused Chief of Staff to support the Chief Digital and Information Officer in leading the digital transformation and IT strategy. This key role requires strong expertise in program management, operational excellence, and technology leadership. The ideal candidate will facilitate strategic planning, oversee key initiatives, and enhance collaboration within an innovative environment. Experience in IT strategy and biotech regulatory standards is essential, along with strong interpersonal skills. #J-18808-Ljbffr

A leading biotechnology company in Boston seeks a Senior Director of Global Development FP&A to spearhead financial planning and analysis for clinical trials. The ideal candidate has deep expertise in clinical trial finance, project management, and cross-functional collaboration. Responsibilities include managing complex budgets and providing strategic insights to senior leadership. This hybrid-eligible role offers a competitive salary and benefits package. #J-18808-Ljbffr

Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you'll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We're passionate about innovation, inclusion, and supporting your growth-inside and outside the lab. Why Vertex? Real Projects: You'll work on assignments that make a real impact, not just busy work. Mentorship & Networking: Connect with leaders and peers who want to see you succeed through professional networks, connections, and collaborations that will shape your longer-term career. Flexible & Supportive: We offer flexible work options with Flex @ Vertex and prioritize your wellbeing. Inclusive Culture: Collaboration and inclusion are embedded in everything we do. Career Launchpad: Build skills, explore career paths, and get guidance for your future career. Ready to apply? Submit your application and let's turn possibilities into reality! Your Impact The Vertex Research internship program is a multi-week experiential training program for students currently working towards an undergraduate degree in Chemistry, or a related field of study. If you are passionate, collaborative, and growth-minded, an internship at Vertex will help you gain meaningful experience in our Drug Substance Development functional areas and serve as a launchpad for your career. Important Notice Regarding Internship and Co-op Inquiries At Vertex Pharmaceuticals, we are committed to providing a fair and structured recruitment process for all students interested in internship and co-op opportunities. To ensure consistency and equity, all student applications must go through our Early Talent Acquisition Team. Due to the high volume of interest, we are unable to respond to individual solicitation. Direct solicitation to Vertex employees- including senior leaders via email will result in removal from the recruiting process. We appreciate your enthusiasm and interest in Vertex. To be considered for internship or co-op roles, please apply directly through our official application channels. (************************************************************************** Thank you for respecting our process and helping us maintain a fair experience for all candidates. What you will be doing: As part of Drug Substance Development Team, we apply synthetic organic chemistry and process chemistry principles and techniques in the development of practical processes for Active Pharmaceutical Ingredients (APIs) amenable for mass production. The summer Intern will gain professional hands-on experience working in a pharmaceutical company. An understanding of synthetic organic chemistry with laboratory experience is expected. As a Process Chemistry Intern, you will have the opportunity to Work closely with an experienced process chemist to learn the fundamental knowledge and laboratory techniques on process development and optimization, synthesis and characterization of small molecule organic compounds, developing analytical thinking and problem-solving skills. Maintains a well-written and organized notebook Involves in group discussion, present work and communicate with other team members What you will need to succeed: This position is fully onsite at our Boston MA location Must be pursuing a Bachelor's degree in chemistry Undergraduate student with completion of a minimum of one year of university studies Completed college coursework for General Chemistry and Organic Chemistry and associated laboratory work Excellent communication, collaboration and interpersonal skills Legal authorization to work in the United States, now and in the future. Please note that Vertex does not provide sponsorship for internships or entry level roles within this part of the organization. You must be enrolled in an advanced degree program if graduating before August 2026 You must be available to work full-time, 40 hours per week from May - August 2026 Program Details: Full-time, paid internship $20.00 - 27.00 USD/hour Program Dates: May - August 2026 At Vertex, we believe that when you feel your best, you can perform at your best. That's why our US benefits and global well-being resources are designed to support you. • Free 24/7 onsite gym access and free access to group exercise classes • Subsidized commuter benefits- transit and parking • Provided meals-free breakfast daily! • Career development opportunities and events, including C Suite engagement • Social events-both intern-only and company-wide • Location-specific perks and extras! • Recognition of National Intern Day Equal Opportunities Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Vertex is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accessibility & Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Vertex is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role, Vertex is unable to sponsor non-U.S. persons to apply for an export control license. This job posting is for a temporary role with a third-party agency partner that provides services to Vertex. The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer. For any questions or concerns, please contact early_***************. Pay Range: $0 - $0 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers For a full list of our comprehensive benefits, see our website: ******************************* The Importance of the Role The responsible individual will play a critical role in supporting, leading and development of the department of Medical Information & Review within the Medical Affairs function reporting to the Head of Global Medical Information & Review. This individual will work closely and effectively with key members of internal departments including Marketing, Legal/Compliance, Regulatory, PV, Medical Affairs and Clinical Development to assure that all materials, both promotional and medical, meet the rigorous standards of scientific accuracy, objectivity, and fair balance. This person will also serve on cross functional teams, representing medical affairs. The Opportunity to Make a Difference Develop and implement global medical information strategies aligned with biotech innovation and patient-centric values. Create and maintain scientifically rigorous Standard Response documents based on emerging data and publications. Manage external vendors and call center operations to ensure high-quality, timely responses to inquiries from healthcare professionals and patients Serve as a key member of MRC & PRC review committees Provide timely, medically relevant, scientifically sound, and fair-balanced medical/scientific reviews of materials submitted to medical and promotional reviews Responsible for providing oversight of the review of promotional and medical materials for scientific/medical validity across Sarepta's Portfolio. Represent medical affairs in global cross-functional team meetings Critically review and provide solutions to complex promotional and medical pieces to ensure balance of the messages, medical accuracy, and appropriateness of the content of the materials/activities in accordance to scientific communication and with relevant guidance across Sarepta. Proactively cultivate and grow strong relationships with cross-functional leads and other stakeholders to provide medical guidance in the development of scientific materials and resolve issues or concerns in promotional and medical review Leverage defined metrics and other tools to improve team performance and ensure adequate resource allocation Determine acceptability of data/references used to support promotional claims and provide expert guidance as well as effective negotiation leading to resolution for approval of pieces Address any scientific decision support needs from inquiries coming into Sarepta. Maintains in-depth understanding of the disease state, product, competitors, marketplace, related medical areas, and regulatory guidelines Participate in the creation of, and ensure adherence to, departmental and corporate policies and SOPs and constantly look for places where process improvements would enhance the workflow Support commercial planning and launch planning activities including training materials, and medical information to provide scientific and medical support for publications and presentations Monitor the medical literature for Sarepta product(s) and relevant competitor data; analyzes the information for accuracy and relevance and appropriately synthesizes the data for inclusion in materials under review. Collaborate with commercial operations, marketing, and regulatory operations to support the creation and submission of marketing materials and documentation to regulatory agencies Collaborate with Global Medical Communications and Medical Information to align with scientific information, establishing consistent communication Assist in driving consistency in medical information and communications, establishing one medical voice internally and externally Participate in internal and external meetings (training, educational and others, including medical congresses) to remain current on ever changing regulations, relevant new medical/scientific information and commercial strategy More about You Advanced clinical/scientific degree: PharmD, PhD with 3 to 5 years of experience in medical affairs Scientific expertise in rare disease and gene therapy a plus Prior knowledge of the medical information and review process Excellent interpersonal, written, and verbal communications skills are essential to establish cross functional relationships. High degree of accuracy; eye for detail, fastidious Ability to effectively manage time while balancing numerous high priority projects with a sense of urgency Must be a strong team player and be willing to work in an environment where individual initiative and accountability to the team are required Self-motivated with exceptional follow through Demonstrates flexibility in response to changing needs and competing demands Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion. What Now? We're always looking for solution-oriented, critical thinkers. So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid#LI-CM1This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.