80 jobs found in Waltham

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development. This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders. The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional...

Alkermes, Inc. Responsibilities Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs). Approve validation deliverables including initial implementation and operational changes. Change ownership, including initiating and managing change through completion. Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS. Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues. Lead and manage ongoing meetings with the vendor/IT as necessary. Report status and issues to governance committees/senior leadership. Communicate milestones and planned changes to user community promoting use of QMS. Responsible for representing owned QMS...

Alkermes, Inc. Responsibilities Responsible for all quality systems in scope from the Global Process Function/Operational process standpoint. Report to the Director of Quality Systems and Compliance. Responsible for initial implementation and validation support, periodic review and operational support to maintain systems in a validated state. Facilitate development, maintenance, and reporting of Quality System metrics to senior leadership on a periodic basis. Facilitate development and implementation of Global SOPs/Standards/Guidelines with respect to Quality Systems Management in-line with Alkermes Quality philosophy, regulations, and industry best practices. Evaluate and lead initiatives on harmonization of Quality Systems management. Facilitate and lead continuous improvement of approach to quality systems and processes by identifying, proposing and implementing systemic changes. Coordinate with other impacted Quality groups and Site Process Owners to gather...

Alkermes, Inc. The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight, for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives. Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with the cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently...

Alkermes, Inc. Position: Director, Process Development Position Summary: An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities at the Waltham site, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This position is responsible for leading and empowering the Process Development Team in taking Alkermes' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities and Requirements: Lead process development strategy for...

Alkermes, Inc. We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting CNS therapeutic area as a key member of Clinical Pharmacology, DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams. This position will have a core scientific responsibility of selecting optimal doses and dosage regimens in patients, and will integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). This role will provide the opportunity to support multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable. Essential Areas of Responsibility: Contributing to clinical program design, trial protocols,...

Alkermes, Inc. KEY AREAS OF JOB ACCOUNTABILITY: Provides process and technical leadership and assumes accountability for Quality System applications as assigned and will be ultimately responsible for ensuring that the quality system is compliant, and its operations are fit for intended use in accordance with applicable global procedures. Spearhead the improvement and management of DMS/QMS applications, as assigned, including harmonization of processes across sites. Responsible for defining the directional course of quality systems implementation and upgrade projects, ensuring comprehensive consultation and communication with impacted teams, individuals, and stakeholders. Responsible for requirements - authoring and on-going maintenance by leading and facilitating meeting/workshops with Site Process Owners and Key Users (Business SMEs) Lead development of and approve validation deliverables as a Global Process Owner as assigned- initial implementation and...

Alkermes, Inc. Job Title Senior System Analyst III - Clinical Manufacturing Suite Location Waltham, MA (Hybrid Office Schedule) Position Summary The IT Senior System Analyst III for Clinical Manufacturing Suite will lead all technology implementation, production support, and maintenance activities within the Clinical Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding and validating new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS. Partnering closely with CMC, quality, and regulatory teams, the IT Senior System Analyst III ensures alignment with FDA and global regulatory standards while fostering continuous improvement, operational excellence, and strong collaboration across the organization. The role requires deep...

CSL CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Director, Epidemiology? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three...

CSL CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager US Advertising and Promotion Lead? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Head, Global Advertising & Promotional Position Purpose Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties. Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products. Review, approve, or reject promotional...

Repligen Overview Responsible for performing the physical tasks involved in the shipping, receiving, storing, and distributing of products, materials, parts, supplies and equipment. Unpacks and checks goods received against purchase orders or invoices, maintains records of received goods, rejecting unsatisfactory items where necessary. Pulls and fills orders. May use (but not limited to) power equipment such as a forklift, hand tools, and other devices operated in a warehouse environment. This position is not responsible for operating delivery trucks which require a Commercial Drivers License. Prepares and maintains records of merchandise shipped. Posts weights and shipping charges and prepares goods for final shipment. Examines stocks and distributes materials in inventory and on manufacturing lines. May prepare kitting packages for assembly production. This position is a 1st shift role at our Waltham, MA warehouse facility. Responsibilities Loads and unloads product to...

Alkermes, Inc. Position: Senior Director, New Product Planning (NPP) - Neuroscience This position offers a candidate the opportunity to significantly contribute to the long-term commercial success of the portfolio. This position is responsible for leading clinical development stage programs towards commercial success through market assessments and effective interactions across multiple functions. This is role will work a hybrid weekly office schedule in our Waltham location. Responsibilities Key Responsibilities: Lead development of forward-looking strategies, market positioning and product profiles for neuroscience pipeline products by synthesizing primary and secondary inputs that inform the development and lifecycle plan Co-lead (with development colleague) product teams through clinical development phases, working in conjunction with internal business partners (e.g. clinical, translational medicine, regulatory, research, commercial, CMC) to optimize the market...

Alkermes, Inc. The Associate Director of Consumer Marketing will be responsible for developing and implementing tactical marketing programs, primarily for consumers and caregivers, supporting the bipolar 1 disorder and schizophrenia indications of LYBALVI. This includes Direct-to-Consumer (DTC) strategy, media plan, content development, and analysis. The position requires an experienced and highly motivated individual with strong strategic and leadership capabilities. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. Responsibilities Key Responsibilities: Manages the execution of consumer promotional campaigns for LYBALVI Crafts actionable assignment briefs for creative agencies Manages the development of the consumer media plan, channel allocation, targeting and measurement required to deliver on business and...

Alkermes, Inc. Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases IIV of development. Responsibilities Clinical project team member: works closely with the Sr. CTM and/or Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations. Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing Oversees and works directly with CROs, vendors, field monitors and other partners. Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation,...

CSL The AI/ML Advanced Analytics, Automation & Digital Agent CoE Lead is responsible for shaping and executing the AI and automation strategy across R&D. This role integrates advanced analytics, machine learning, intelligent automation, and digital agents to drive scientific and operational excellence. The leader oversees capability building, governance, technical standards, and external engagement to deliver innovation at scale while ensuring compliance and measurable business value. Main Responsibilities & Accountabilities *Define and implement integrated AI/ML and automation strategy across R&D, aligned with business priorities.*Oversee development and deployment of advanced analytics models, automation tools, and digital agents to streamline R&D processes.*Lead governance and establish standards for responsible AI, ML Ops, and automation toolkits.*Collaborate with internal stakeholders (e.g., Digital Business Partners, I&T, lab owners) and...

Alkermes, Inc. We are seeking a highly motivated, experienced hands-on Associate Director of Information Security (Cloud and Emerging Technology) to take a leadership role in shaping and executing the organizations security strategy in advanced technologies. Reporting to the Director of Information Security, this position will oversee a small team of security professionals and act as a trusted advisor across IT, and business units. This role will be responsible for developing, implementing, and enforcing security frameworks and guardrails for cloud environments (primarily AWS), AI/ML platforms, Large Language Models (LLMs), and DevSecOps practices. In this role, the Associate Director will lead efforts to secure cloud and emerging technologies, ensuring compliance with regulatory requirements and alignment with organizational risk appetite. Responsibilities Essential Duties and Responsibilities Lead, mentor, and manage a small team of security professionals, fostering...

Repligen Overview Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us! A fast-growing and acquisitive global public company is looking for a strong, experienced, and detail-oriented Senior Director of Finance reporting directly to the Vice President of FP&A. This represents an opportunity to work in a key finance leadership role with significant levels of executive visibility. This role must pay great attention to detail, deliver results, and operate cross-functionally in a rapidly changing environment. This role is a critical business...

National Grid About us National Grid is hiring a Senior Reporting Analyst for our Kraken Transformation department. This is a Hybrid Role - Must live within a commutable distance to any of the following locations: Albany, NY, Syracuse, NY, Brooklyn, NY, Hicksville, NY, or Waltham, MA. Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the energy they need for the lives they live. The pace of change in society and our industry is accelerating and our expertise and track record puts us in an unparalleled position to shape the sustainable future of our industry. To be successful we must anticipate the needs of our customers, reducing the cost of energy delivery today and pioneering the flexible energy systems of tomorrow. This requires us to deliver on our promises and always look for new opportunities to grow, both ourselves and our business. Job Purpose As a Senior...

National Grid About us Superpowered. Meaningful work. Human impact. A story we're proud to tell. This is what matters to us at National Grid. In a world of complexity and unanswered questions, there is one thing we're certain about: the power of our people. National Grid is hiring a Lead Project Manager (Electricity), Capital Project Delivery for Massachusetts. This is a Onsite Role - Must live within a commutable distance to Waltham, MA. Job Purpose We are seeking a dedicated individual to oversee and execute the planning, delivery, management, and governance of our Electric Capital Projects. In this pivotal role, you will be responsible for ensuring that these projects are developed in a cost-effective and purposeful manner, while also improving long-term project robustness, requirements, costs, and timelines. Opportunities * Collaborate with a diverse and expanding team, sharing accountability for the timely delivery of capital infrastructure essential to...

National Grid About us Superpowered. Meaningful work. Human impact. A story we're proud to tell. This is what matters to us at National Grid. In a world of complexity and unanswered questions, there is one thing we're certain about: the power of our people. National Grid is hiring a Senior Project Manager (Electricity), Capital Project Delivery for Massachusetts. This is a Onsite Role - Must live within a commutable distance to Waltham, MA. Job Purpose We are seeking a dedicated individual to oversee and execute the planning, delivery, management, and governance of our Electric Capital Projects. In this pivotal role, you will be responsible for ensuring that these projects are developed in a cost-effective and purposeful manner, while also improving long-term project robustness, requirements, costs, and timelines. Opportunities: * Collaborate with a diverse and expanding team, sharing accountability for the timely delivery of capital infrastructure essential to...