Director of Supply Chain Operations at elevatebio | Waltham

Role Overview elevatebio is hiring a Director of Supply Chain Operations in Waltham, Massachusetts. This leadership role guides the strategic planning and daily execution of supply chain activities. The position focuses on building efficient processes, maintaining operational integrity, and supporting the company's mission in biotechnology. Key Responsibilit…

About ElevateBio ElevateBio supports partners in advancing therapies from early development through commercialization. The team combines advanced technologies, broad services, and deep manufacturing know-how to help bring new therapies to market efficiently. Role Overview: Facilities Technician II This Facilities Technician II position is based in Waltham, Massachusetts. The role focuses on maintaining and supporting GMP utility systems, process equipment, and cleanroom infrastructure in a regulated cGMP setting. The schedule runs Wednesday through Saturday. Participation in an on-call rotation and occasional extra shift coverage, especially during annual shutdowns, is required. Key Responsibilities Complete maintenance tasks using a Computerized Maintenance Management System (CMMS). Document all work according to Good Manufacturing Practices (GMP), both electronically and in writing. Report maintenance failures or issues to management promptly. Assess equipment performance and recommend improvements to maintenance practices or system design. Look for ways to improve maintenance methods. Interpret P&IDs, equipment and system layouts, wiring diagrams, and specifications to plan and perform maintenance or repairs. Support facility operations during annual shutdowns. Perform routine preventative maintenance on process support systems and equipment, including (but not limited to): pumps, valves, autoclaves, centrifuges, reactors, biosafety cabinets, isolators, WFI generation/distribution, clean steam, compressed gases, and HVAC systems. Conduct rounds on both GMP and non-GMP equipment and systems. Inspect, operate, or test machinery and equipment to identify malfunctions. Handle routine maintenance tasks such as checking fluid levels, replacing filters, and inspecting motors and drives. Diagnose mechanical issues and determine corrective actions using blueprints, repair manuals, or parts catalogs as needed. Repair machinery, equipment, or structures using a variety of tools and precision instruments.

Role Overview elevatebio is seeking an Associate Director of Billing and Revenue Accounting in Waltham, Massachusetts. This role leads a team focused on accurate billing and revenue recognition. The position centers on refining financial processes and applying industry best practices to improve efficiency. Key Responsibilities Oversee billing operations and revenue accounting activities Guide and support a dedicated accounting team Ensure accuracy in billing and revenue recognition Implement process improvements to strengthen operational workflows About elevatebio elevatebio works to advance cell and gene therapies. The Associate Director of Billing and Revenue Accounting will help support this mission by maintaining high standards in financial operations.

ElevateBio develops and manufactures advanced therapies, working with partners from early stages through to commercialization. The company combines a range of technologies, services, and manufacturing expertise to help advance new therapies efficiently. Role overview The Quality Assurance Validation Specialist I will join the QA Validation Group and focus on Commissioning and Qualification (CQV) activities for quality control laboratories, manufacturing suites, and related equipment. This position supports quality assurance within a cGMP environment. Main responsibilities Oversee QA activities for CQV processes in cGMP manufacturing facilities and quality control labs. Manage QA oversight for periodic reviews and requalification programs. Review Computerized Maintenance Management System (CMMS) records for asset management, including asset release, database requests, and work orders. Provide QA oversight for quality events related to validation and engineering, such as deviations and CAPAs. Contribute feedback as part of cross-functional teams on inspection readiness activities. Author and review Standard Operating Procedures (SOPs) in Veeva. Requirements Strong understanding of Commissioning and Qualification processes for laboratory and manufacturing environments, including equipment and instrumentation. This role is based in Waltham, Massachusetts.

ElevateBio is a pioneering technology company dedicated to advancing the biotechnology landscape. We empower our partners to unlock the full potential of their therapies, guiding them from initial design through to successful commercialization. Our unique blend of innovative technologies, comprehensive services, and top-tier manufacturing expertise allows us to expedite the development of advanced therapies with remarkable efficiency.About ElevateBioAs a leader in the biotech industry, ElevateBio integrates cutting-edge technologies and unparalleled services to enhance the therapeutic development journey. Our mission is to transform the potential of therapies into reality, ensuring faster and more effective solutions for patients worldwide.The Role:We are in search of a dynamic and results-oriented Director of Commercial Excellence to spearhead the optimization of our comprehensive commercial operations. Reporting directly to the Chief Commercial Officer, this pivotal role is responsible for enhancing sales effectiveness, refining go-to-market strategies, and fostering alignment among sales, marketing, and cross-functional teams. The ideal candidate will possess strong analytical skills, operational leadership experience, and a fervent commitment to developing scalable processes, high-performing teams, and data-informed strategies.Key Responsibilities:Design and continuously refine the end-to-end sales process to boost efficiency and expedite the sales cycle, incorporating innovative solutions such as AI-driven proposal generation.Lead the strategy for our commercial technology stack, taking full ownership of the CRM system to ensure data integrity, user engagement, and system enhancements that align with sales and marketing goals.Transform raw CRM data into actionable insights, crafting informative dashboards and reports that track sales performance trends, enable accurate forecasting, and provide strategic recommendations to senior management.Develop and implement a comprehensive onboarding program for all new sales and commercial team members, instilling our company culture, values, and core sales methodologies from the outset.Establish and promote an ongoing learning initiative for the commercial team, providing regular training on new product features, evolving value propositions, competitive landscape, and best practices.Oversee the planning and execution of strategic Go-to-Market (GTM) initiatives, ensuring seamless collaboration between a well-equipped sales team, marketing, and product development to maximize market impact.

ElevateBio is a pioneering technology firm that accelerates the advancement of the biotechnology sector by enabling partners to unlock the full potential of their therapies, from conception through to market launch. Our unique combination of cutting-edge technologies, comprehensive services, and top-tier manufacturing expertise allows us to develop advanced therapies more efficiently and effectively.The Role:We are seeking a detail-oriented and analytics-driven CRM Manager to take charge of our HubSpot platform, enhancing both marketing and sales effectiveness. This pivotal role will involve managing marketing automation efforts, ensuring data integrity, and delivering actionable insights that promote revenue growth. The ideal candidate will possess strong technical skills along with a strategic mindset, coupled with a fervent commitment to optimizing processes and empowering teams through proficient CRM utilization.Key Responsibilities:Act as the primary system administrator and expert for the HubSpot platform, overseeing user roles, system configurations, and daily operations to guarantee peak performance.Design, implement, and manage multi-step lead nurturing campaigns and marketing automation workflows in HubSpot, effectively guiding prospects through the buying journey and providing marketing-qualified leads to the sales team.Proactively oversee the health and integrity of the HubSpot database, conducting regular data cleansing, deduplication, and enrichment to maintain the accuracy of all commercial data.Create and manage dashboards and reports to meticulously track and analyze campaign performance, delivering clear insights on open rates, click-through rates, conversion, and pipeline influence to the Director of Commercial Excellence.Develop dynamic and static contact lists to facilitate precise audience segmentation for targeted email campaigns, sales outreach, and event invitations.Collaborate closely with the sales team to develop and refine HubSpot assets that enhance efficiency, including email templates, sales sequences, and lead scoring models that prioritize outreach efforts.Generate comprehensive documentation for HubSpot processes and provide ongoing support and training to sales and marketing teams, ensuring adherence to best practices and fostering platform adoption.

This Associate II, Quality Control role at elevatebio focuses on maintaining rigorous quality standards for products and processes. The position is located in Waltham, Massachusetts and supports the company's commitment to compliance and operational excellence. Key Responsibilities Perform quality assessments to ensure both compliance and consistency across operations. Implement established quality control procedures throughout daily activities. Collaborate with colleagues from various departments to address regulatory requirements. Identify opportunities for process improvement and contribute to strengthening quality systems. Requirements Strong analytical skills for reviewing data and evaluating processes. Close attention to detail when handling quality documentation and procedures. Background in regulated environments is considered valuable.

Oruka Therapeutics develops biologic treatments for chronic skin conditions, including plaque psoriasis. The company’s approach centers on infrequent dosing and proprietary antibodies designed to address dermatologic and inflammatory disorders. Oruka is headquartered in Waltham, Massachusetts, and operates as a publicly traded company (Nasdaq: ORKA). Role overview The Senior Manager, Clinical Supply Chain (Biologics) leads supply chain operations for clinical trials spanning early to late development stages. This hybrid role is based in Waltham, MA, with an on-site presence required three days per week. The position reports to the head of Clinical Supply Chain and supports multiple trials in the US, Canada, and the EU. Key responsibilities include managing labeling, packaging, distribution, inventory, forecasting, and handling supply expiration. The Senior Manager also oversees IRT (Interactive Response Technology) initiation and maintenance. Collaboration with CMC, Clinical, Program Management, Regulatory, and Quality teams is central to the work, as is helping to establish supply chain best practices and processes. The scope covers global activities, with particular attention to supplies such as vials and pre-filled syringes. Key responsibilities Carry out clinical supply chain tasks, including labeling, packaging, and inventory management. Oversee distribution, forecasting, and supply expiration for clinical trials. Initiate and maintain IRT systems to support trial operations. Work closely with cross-functional teams to ensure alignment and compliance. Support development and implementation of supply chain processes and best practices. Requirements Experience managing clinical supply chain operations for biologics, ideally across multiple regions. Strong communication skills and a results-oriented approach. Ability to work effectively with cross-functional teams and external partners. Familiarity with clinical trial supply needs, especially for vials and pre-filled syringes. Hybrid work schedule: in-office presence in Waltham, MA, three days per week. For more about Oruka Therapeutics, visit www.orukatx.com.

About Anduril Industries Anduril Industries builds technology to strengthen U.S. and allied defense capabilities. The company combines technical expertise with a modern approach to designing, producing, and delivering military systems. Its family of products runs on Lattice OS, a platform that brings together large volumes of data into a real-time, 3D command and control center. Anduril focuses on delivering autonomy, artificial intelligence, computer vision, sensor fusion, and networking solutions to military partners quickly, often in months rather than years. Role Overview: Demand Planner This Waltham-based role centers on planning for Anduril’s Battlespace Awareness products. The Demand Planner will work closely with teams across the company, including Leadership, Business Development, Supply Chain, Procurement, Production, Finance, and Operations. Success in this position means structuring complex planning problems and adapting to shifting priorities to keep product demand aligned with business goals. What You'll Bring Experience collaborating with a wide range of internal stakeholders Skill in organizing and solving complex planning challenges Comfort working in environments where priorities and conditions change rapidly Adaptability to ensure demand for Battlespace Awareness products stays on track

Role Overview:The Director of Clinical Operations plays a pivotal role in ensuring that clinical stage programs meet both strategic and operational objectives in compliance with set timelines, budgets, and quality standards. This leadership position is vital in guiding the Clinical Operations team, shaping clinical program strategies, and fostering collaboration and transparency across multiple functions. The Director will work closely with both internal stakeholders and external partners to facilitate high-quality clinical trial execution within the dynamic landscape of a small-to-midsize biotech organization.Key Responsibilities:Program Strategy & Leadership (35%)Formulate and implement clinical program strategies that are aligned with corporate objectives. Lead the Clinical Operations team to optimize the allocation of resources across various programs.Clinical Trial Oversight (25%)Ensure that clinical trials are meticulously defined, planned, and executed in accordance with GCP, ICH, and FDA regulations. Monitor study timelines, budgets, and quality metrics to drive operational excellence.Regulatory & Documentation Support (15%)Assist in drafting key regulatory documents, ensuring that clinical program outputs meet submission requirements and regulatory standards.Vendor & CRO Management (15%)Oversee and manage Contract Research Organizations (CROs), vendors, and external partners to ensure that performance, deliverables, and financial accountability align with expectations.Team Development & Collaboration (10%)Cultivate a collaborative environment within Clinical Operations and exemplify leadership values. Encourage transparent communication, accountability, and operational discipline across the department.Other duties as assigned.

Xometry (NASDAQ: XMTR) is at the forefront of empowering the industries of today and tomorrow by connecting visionary thinkers with manufacturers capable of turning their ideas into reality. Our digital marketplace equips manufacturers with essential resources for business growth while facilitating effortless access to global manufacturing capabilities for buyers at Fortune 1000 companies.We are on the lookout for a highly motivated and experienced Program Manager, Operations to become a vital part of our dynamic and innovative team. This role is pivotal in managing cross-functional initiatives aimed at improving operational efficiency, enhancing scalability, and propelling our growth in advanced manufacturing. Candidates with a background in the automotive or manufacturing industry will be given priority.

Join our dynamic team at Biocytogen, a rapidly expanding company in the Pharmacology and Contract Research Organization (CRO) sectors. We are looking for a dedicated Laboratory Operations Associate who possesses robust laboratory management experience and a background in biotechnology process development. The ideal candidate is a self-motivated and organized individual who thrives in a collaborative scientific environment, adept at understanding the study and technical requirements of our researchers.Key Responsibilities:Oversee the daily operations to ensure seamless functioning of the laboratories and animal facility.Manage multiple laboratory workflows, including equipment and device upkeep, adherence to lab safety protocols, and meticulous record-keeping.Maintain digital organization and routine updates of lab inventories, including cell stock banking and sample storage in various locations.Procure essential lab supplies promptly from certified vendors while maintaining accurate transaction records.Conduct supplier research to explore alternative options and obtain competitive quotes for logistics and pricing.Build and lead the lab operations team as necessary.Provide project support as required.Act as the emergency coordinator for troubleshooting lab equipment issues.

Xometry (NASDAQ: XMTR) is at the forefront of innovation, bridging the gap between visionary thinkers and manufacturers capable of transforming ideas into reality. Our cutting-edge digital marketplace equips manufacturers with essential tools to expand their operations, while facilitating seamless access to global manufacturing capabilities for Fortune 1000 companies.We are currently in search of a dynamic and results-oriented Senior Operational Excellence Manager to become an integral part of our expanding team. This role is tailored for an analytical strategist and proactive executor, adept at scrutinizing operational and customer service data, pinpointing inefficiencies and performance gaps, and converting insights into tangible enhancements. In collaboration with cross-functional teams including Customer & Partner Support and Partner Network Management, you will spearhead scalable process improvements and establish standards that boost efficiency, elevate customer and partner satisfaction, and enhance financial outcomes.

At ElevateBio, we are a pioneering technology company at the forefront of advancing the life sciences. We empower our partners to unlock the full potential of their therapies, guiding them from initial design through to successful commercialization. Our unique blend of innovative technologies, comprehensive services, and unparalleled manufacturing expertise enables us to accelerate the development of cutting-edge therapies efficiently and effectively. The Opportunity:We are seeking a talented Manufacturing Execution System (MES) Engineer II to join our dynamic team. Reporting directly to the Associate Director of Operational Technology, you will play a crucial role in supporting and optimizing our Manufacturing Execution System. As an experienced member of the MES team, you will help us enhance our capabilities as a Contract Development and Manufacturing Organization (CDMO). This position may involve some supervisory responsibilities as delegated.Your Responsibilities:Collaborate with the MES team and Manufacturing Operations:Provide expert support to the MES team, ensuring the successful execution of all related activities.Assist Senior MES Engineers with MES initiatives and projects.Identify and implement process improvements for MES team efficiency and effectiveness.Deliver technical support for manufacturing operations, including on-call assistance and troubleshooting MES issues with software vendors.Manage administrative duties for the MES system, including user access, system configurations, and security settings.Mentor junior MES engineers and foster a collaborative, innovative, and respectful work environment.Perform additional duties as assigned.Logbook & Batch Record Templates and Tech Transfer Support:Design, develop, and test templates for Electronic Batch Records (EBRs) and Electronic Logbooks (eLogs).Establish best practices for template design in collaboration with Manufacturing and Science Technology (MSAT), Manufacturing (MFG), and Quality Assurance (QA).Enhance the template design and testing strategy.Assist stakeholders and clients in understanding MES requirements during tech transfer projects, including change management and template development timelines.

Oruka Therapeutics is developing biologics designed to change the treatment landscape for chronic skin conditions such as plaque psoriasis. The company focuses on long-lasting relief for patients, aiming for outcomes like disease clearance with infrequent dosing. Their pipeline includes proprietary antibodies created by Paragon Therapeutics, targeting the underlying causes of dermatologic and inflammatory diseases. More details about their work can be found at www.orukatx.com. Role overview The Associate Director of Clinical Operations will manage the setup and execution of clinical trials, supporting the Director of Clinical Operations within a specific therapeutic area. This position oversees multiple studies, combining strategic planning with day-to-day operational involvement to keep clinical programs on track and within budget. Responsibilities include handling operational details, anticipating challenges, and implementing solutions to ensure trial progress. The role requires someone who can move between leadership and hands-on work, maintaining a player/coach mindset throughout. What you will do Oversee all phases of clinical trial setup and execution across several studies Support the Director of Clinical Operations in a designated therapeutic area Balance strategic planning with direct, hands-on involvement in daily operations Identify and resolve operational challenges to maintain study timelines and budgets Requirements Demonstrated integrity and sound judgment in clinical operations Ability to shift between high-level oversight and direct involvement as needed Strong commitment to study goals and a collaborative approach Adaptability and resourcefulness in a biotech setting This hybrid role is based in Waltham, Massachusetts, with an expectation of three days onsite each week. The team values learning, growth, and a positive, inclusive culture.

Join Biocytogen as a dedicated Administrative Assistant, where you will play a pivotal role in supporting our HR department and enhancing operational efficiency. We seek an individual who is organized, reliable, and proactive in contributing to a positive workplace culture. If you have the necessary skills and a passion for excellence, we invite you to apply!Key Responsibilities:Handle various administrative tasks including phone management and appointment scheduling.Assist in enforcing company policies and standards to support operational effectiveness.Coordinate logistics for trade shows, seminars, conferences, and other events.Maintain and update company databases accurately.Facilitate communication with internal and external stakeholders.Provide general administrative support to operations and HR as needed, including photocopying, filing, scanning, and data management.Perform additional tasks as assigned.

At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the development of potentially groundbreaking treatments, whether as standalone interventions or in combination therapies targeting various solid tumors. For more insights into our mission and vision, visit our website and connect with us on LinkedIn and X.We are currently in search of an Associate Director or Director of Analytical & GMP Quality Assurance Operations. In this pivotal role, you will oversee and guide the QA functions related to analytical development, quality control operations, and GMP quality activities across our clinical-stage biologics and ADC programs. Collaboration with cross-functional teams, including CMC, Analytical Sciences, Quality Control, and Technical Operations, as well as external manufacturing and testing partners, will be key to ensuring compliance with phase-appropriate GMP standards, maintaining data integrity, and ensuring inspection readiness within a dynamic outsourced operational framework. Your strategic vision will be instrumental in shaping Crescent's analytical quality strategy and driving the disciplined execution of core quality systems that align with our aggressive development timelines.

Join ServiceNow as the Director of Monetization Strategy, where you will spearhead innovative approaches to maximize our revenue streams and enhance customer satisfaction. In this pivotal role, you will collaborate with cross-functional teams to develop strategic frameworks and drive our monetization initiatives. Your expertise will ensure that our products not only meet market demands but also exceed our financial targets.

Join our dynamic team as a Retail Merchandiser at CROSSMARK in Waltham, Massachusetts. In this role, you will be responsible for enhancing product visibility in retail environments, ensuring that displays are attractive and aligned with marketing strategies. You will collaborate with various stakeholders to optimize product placement, monitor inventory levels, and provide exceptional service to our clients.

About Us:Oruka Therapeutics (Nasdaq: ORKA) is pioneering innovative biologic therapies aimed at transforming the treatment landscape for chronic skin conditions. Our mission is to empower individuals suffering from chronic skin diseases, such as plaque psoriasis, by providing unprecedented freedom from their ailments through treatments administered as infrequently as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies developed by Paragon Therapeutics, targeting the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory disorders. For more details, visit www.orukatx.comAs we fortify our core team, we are on the lookout for exceptional talent across various domains. We seek individuals who are not just looking for employment, but are eager to contribute to a larger purpose. If you are passionate about making a significant impact and are keen on fostering an engaged, inclusive, and positive workplace culture, we want to hear from you.Job Title: Associate Director/Director of Analytical Development and Validation - Tech Operations (Biologics)Location: Hybrid – Waltham, MA. Candidates are expected in the office 3 days a week. Remote considerations may apply.Role Overview:The Associate Director/Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities that support the development, validation, and lifecycle management of biologic drug products, particularly monoclonal antibodies. This position will oversee method validation and comparability initiatives essential for BLA/MAA submissions, process modifications, and commercial readiness, collaborating closely with CMC, Quality, Regulatory Affairs, and external partners.The ideal candidate is a proactive leader with extensive experience in analytical method validation, device functional testing, and regulatory frameworks for late-stage biologics. You will guide teams through intricate technical and compliance milestones, making this a highly visible role within the CMC team. Join our expanding organization and play a crucial part in supporting multiple programs’ analytical activities, facilitating the release of supplies for clinical trials, and preparing for commercialization in the US, Canada, and EU.