The Role:

ElevateBio is looking for a Senior Associate Process Engineer within Manufacturing Technology and Sciences organization. As a Senior Associate Process Engineer in Manufacturing Science and Technology, you will provide technical support for GMP manufacturing including support for Visual Inspection (VI) Program, Deviation and Investigation, Change Control and CAPA implementations and continuous improvement projects within a highly matrixed cross functional team for Base Camp programs. As part of support, you will write protocols, product impact assessments, root-cause analysis reports, technical reports. You will support data collection and charting for non-GMP and GMP batches.

Here’s What You’ll Do:

• Work cross-functionally across Manufacturing, Quality and Supply Chain to provide support for cGMP manufacturing for both clinical and commercial stage programs across modalities including cell and gene therapy, mRNA and viral vector.
• This individuals focus areas would include support for Visual Inspection program.
• Own and maintain VI related documents
• Maintain VI qualification program including kits and training.
• Monitor and analyze VI related data and own data review meeting and annual data report.
• Own VI related deviations, investigations, product impact statement and related CAPAs
• Work closely with Tech Transfer teams to implement VI program for new program introductions
• Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, work instructions, SOPs.
• Own and support quality events such as deviations, investigations, CAPA, Change Control.

Requirements:

• Bachelor’s Degree in Life Sciences, Engineering, or a related technical discipline, or equivalent experience
• 3+ years of experience in a MSAT, manufacturing or process development role
• Experience in cell and gene therapy, aseptic processing, or parenteral drug product inspection preferred
• Strong communication skills and ability to work cross-functionally with technical and quality teams
• Familiarity with electronic systems used in GMP environments such as Veeva, or electronic batch records

The budgeted range for this position is $90,000-$120,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. 

The Role:

ElevateBio is looking for a Specialist I, People and Culture to help launch and support our new facility in Pittsburgh, PA. This is an exciting opportunity to join as an early team member and play a pivotal role in shaping the foundation for both our People & Culture programs and Office Administration at the site.

In this role, you’ll be a key contributor in driving and supporting our company culture initiatives, while ensuring smooth day-to-day office operations. As our Pittsburgh site grows, so will your impact—making this an ideal position for someone who thrives in a dynamic and evolving environment.

Partnering closely with our broader People and Culture team based in Massachusetts, you’ll serve as the key resource on-site leading local initiatives, coordinating internal events, and ensuring an exceptional employee experience. You’ll collaborate across all teams and levels, helping to foster connection, communication, and a strong sense of community with the broader company.

Here’s What You’ll Do:

• Partner closely with the broader People & Culture team to drive alignment on various initiatives and projects throughout the year. Examples being: facilitation of company/team outings, site town hall meetings, support of annual open enrollment and engagement initiatives
• Serve as a trusted point of contact for employee concerns, workplace issues, and policy questions
• Collaborate with cross-functional teams by participating in training sessions, facilitating employee engagement, and promoting company culture
• Partner with Talent Acquisition, People Experience, and HR Business Partners to coordinate on-site candidate interviews, employee on/off boarding and internal company events
• Oversee day-to-day office operations and procedures, including the employee badging, facility floorplan/seating, and visitor management system(s)
• Support the facilities department in managing food & beverage/office supply programs
• Provide coordination support for meetings, as needed, including catering and conference room calendar management
• Provide ad hoc front desk coverage and liaise with site security as needed

Requirements:

• Bachelor’s degree in Human Resources, Business Administration, or related field
• 3+ years’ experience in Human Resources, Office Administration or related role
• Experience working in a biotechnology or manufacturing setting preferred; an emphasis on supporting a scaling site/office/company encouraged
• Experience with Human Resources systems such as Workday, Greenhouse, CultureAmp preferred
• Ability to work independently, exercising sound judgement and professional maturity.
• Utilize strong communication, organizational and problem-solving skills to manage multiple priorities while interfacing with colleagues at all levels.
• Ability to work onsite in Pittsburgh, PA

The Role:

ElevateBio is seeking an experienced Facilities Technician II to join the team. The successful candidate will be detailed oriented, organized, and have a strong desire to learn. Key responsibilities will be performing or overseeing vendor performed maintenance/calibrations on GMP Utility systems, process equipment and clean room infrastructure in a highly regulated cGMP environment. The candidate must be willing to support on-call rotation and support additional shift coverage as needed including annual shutdown support. The shift coverage for this role is Wednesday-Saturday.

Here’s What You’ll Do:

• Utilizes CMMS to manage the completion of all maintenance assignments.
• Comply with Good Manufacturing Practices (GMP) requirements to include detailed documentation of work performed in both electronic and written form.
• Reports any maintenance failure or issues immediately to management.
• Evaluates equipment performance and makes recommendations to maintenance performance or system design.
• Seeks to continuously improve maintenance practices.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications to plan and perform maintenance and repair activities.
• Provides support during annual shutdowns.
• Routine performance of preventative maintenance on process support systems and equipment including but not limited to: Pumps, Valves, Autoclaves, Centrifuges, Reactors, BSC's, Isolators, WFI Generation/Distribution, Clean Steam, compressed gases, HVAC equipment
• Conducts rounds of GMP and non-GMP equipment and systems.
• Inspect, operate, or test machinery or equipment to diagnose machine malfunctions.
• Perform routine maintenance, such as inspecting drives, motors, or belts, checking fluid levels, replacing filters, or doing other preventive maintenance actions.
• Diagnose mechanical problems and determine how to correct them, checking blueprints, repair manuals, or parts catalogs, as necessary.
• Repair machines, equipment, or structures, using tools such as hammers, hoists, saws, drills, wrenches, or equipment such as precision measuring instruments or electrical or electronic testing devices.
• Maintain or repair specialized equipment or machinery located in cafeterias, laundries, hospitals, stores, offices, or factories.
• Assemble, install, or repair wiring, electrical or electronic components, pipe systems, plumbing, machinery, or equipment.
• Maintains all spaces clean and orderly.
• Coordinating and escorting contractors and vendors for the performance of preventative maintenance and repairs on process support systems.
• Supports quality systems for CAPA, Deviations and Change Management. Dismantle machines, equipment, or devices to access and remove defective parts, using hoists, cranes, hand tools, or power tools.
• Support Annual Shutdown, On-Call rotation and shift coverage.
• Commitment to perform all work in a safe manner. The ability and desire to excel in a fast paced, inclusive team environment which prides itself on providing the highest level of service to our internal customers. Desire to interact in a professional, helpful manner with staff at all levels within the organization on a regular basis.

Requirements:

• High School diploma, GED, or equivalent required
• Trade school or undergraduate education is preferred
• Professionally Licensed in any of the following areas desirable: Wastewater Treatment, Plumbing, Electrical, Refrigeration.
• 1 + years of applicable experience in a GMP environment is preferred
• Ability to multitask and always maintain professionalism
• Proficient in Microsoft Office products (Outlook, Word, Excel, etc.)
• Experience working with Blue Mountain RAM or other CMMS programs preferred
• Experience with DeltaV PCS System or other control system is a plus
• Ability to read, understand, and follow SOP, P&ID's and work instructions.
• Strong communication skills in both oral and written reports

The budgeted range for this position is $48.08 - $62.50. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. 

The Role:

ElevateBio BaseCamp is looking for a collaborative leader to drive meaningful changes and implement end-to-end supply chain strategies, operational plans, KPIs and objectives at the BaseCamp Waltham site. This role will partner closely with functional leadership to drive Planning, Master Production Scheduling, Forecasting, Inventory, Material Planning, and other supply chain capabilities for global clinical and commercialization plans in a multi-modality advanced therapy manufacturing site. The Supply Chain director will have direct responsibility for site incoming demand plans, supply plans, and operational assessments.  role is a critical part of the Waltham Site Leadership Team and reports directly to the Site Head.

Here’s What You’ll Do:

• Provide operational leadership for BaseCamp Waltham’s Planning, Materials Management, and GMP Warehousing functions, including:
  • Site production scheduling, forecasting, and planning processes (e.g. Shop Floor Control/Tiered Meeting structure etc.)
  • Site-level Sales and Operations Planning (SOP) processes including Demand Planning, Production Planning, and Operational Planning for all products and product stages, including partnering with external accounts for joint-S&OP. Executes capacity modeling for existing partners and new potential partner demand forecasting including direct labor, suite modeling, and batch run scenarios. Supports Long Range Planning for suite utilization.
  • Material planning for products from tech transfer through routine clinical and commercial production. Establishment and refinement of planning BOMs and lifecycle management of BOMs for all manufacturing processes. Partner with technical teams to create standard BOM materials and functional equivalent assessments to streamline inventory, where applicable.
  • GMP warehouse activity and third party storage oversight including all aspects of site inventory across labs and manufacturing. Includes oversight of offsite cold chain and ambient storage and management/forecast of third party utilization and spend.
• Ensure consistent, reliable, timely and compliant supply of products in accordance with the forecast and inventory requirements, the planning assumptions, and supply budget. Manage all site incoming and outgoing shipments, including drug product distribution and logistics.
• Develop short- and long-term goals for the department in accordance with overall corporate and site objectives. Create, measure , trend, and report supply related KPIs as a basis to drive continuous improvement.
  • Partner with Quality to conduct risk assessment and supplier audit / qualification in support of site materials management program(s).
• Management of drug product packaging, artwork, and labeling function.

Requirements:

• Minimum Bachelor’s Degree in Engineering, Biotech, Supply Chain, or related field
• At least 10 years of experience in a Manufacturing, Technical Operations, or Supply Chain environment supporting complex products. Experience in autologous gene or cell therapy a plus.
• Direct experience in global demand/supply planning and/or S&OP required.
• Experience working within a contract manufacturing or client service organization strongly preferred
• Expertise in supply chain architectures and systems (e.g. SAP, MRP, planning software)
• Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.

The budgeted range for this position is $190,000 - $260,000. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. 

The Role:

We are seeking an exceptional candidate to join the ElevateBio Finance team. The Finance team at ElevateBio serves as a key stakeholder in every strategic decision the business makes, including cost analysis, pricing, revenue, and line of business profitability analysis.  The Associate Director, Billing and Revenue Accounting will collaborate with multiple teams to manage billings, account receivables, revenue recognition for customer contracts, visionary in initiating and driving enhancement and improvements in the order-to-cash process that will better support the scaling of the business, enhance management reporting and support financial planning and analysis.  This person will be a key member of the Finance team and will work very closely with the Vice President, Corporate Controller to interface regularly with company senior leadership to help the continued growth of the Company.

Here’s What You’ll Do:

• Perform month-end close responsibilities for revenue accurately and in line with closing schedules
• Ensure revenue recognition for customer contracts is in compliance with company policies
• Responsible for building and maintaining a revenue model to support revenue recognition for all major contracts
• Work closely with relevant groups to review contract milestones, pricing, timelines, and related project forecasts
• Prepare monthly management reporting package to highlight key results and provide explanations to senior leadership and business partners
• Oversee the billing and accounts receivable functions, including managing client relationship and communications on all billings related matters.
• Drive improvements/enhancements of the overall billing and revenue cycle by working cross-functionally with the commercial, program management and operations groups
• Partner with FP&A team in the annual budgeting process for all revenue generating activities
• Support the short-term and long-term forecast process including revenue analysis at the company, service, and contract level
• Establish and maintain analysis and support for standalone selling prices and the allocation of transaction prices
• Collaborate with the technical accounting team to document revenue policies and procedures as well as deal specific accounting memos
• Assist with interim reviews and annual external audits
• Key player on SOX implementation team focusing on risk assessment, key controls, documentation, and testing

Requirements:

• Bachelor’s degree in Accounting/Finance/Business required
• Current CPA certification and/or MBA, while not required, will be considered a plus
• Strong knowledge of ASC 606 and the percentage of completion method
• Approximately 8+ years of revenue recognition accounting experience
• Superior oral and written communication skills, including the ability to present complex concepts in a clear and concise manner to all levels of the organization
• Experience in biotechnology and the manufacturing service business
• Successful candidate will be a self-motivated individual, able to achieve high impact in a fast-growing biotech startup

The budgeted range for this position is $170,000 - $210,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. 

The Role:

ElevateBio is looking for a MES Engineer II to join our dynamic team. Reporting to the Associate Director of Operational Technology, this role will be instrumental in supporting our Manufacturing Execution System (MES) and optimizing related processes. The MES Engineer II will be an experienced member of the MES team, supporting our role as a Contract Development and Manufacturing Organization (CDMO). Position is expected to have some supervision responsibilities as needed upon delegation.

Here’s What You’ll Do:

• Supporting the MES Team, plus Manufacturing Operations:
• Support the MES team as one of the more experienced team members, ensuring effective support for all the activities described below.
• Support the Senior MES Engineer(s) in MES-related initiatives and projects.
• Identify opportunities for MES team efficiency and efficacy, and as applicable implement those improvements.
• Provide technical support for manufacturing operations, including on-call support and troubleshooting MES-related issues with software vendors.
• Perform administration support duties for MES system as needed, including user access management, system configurations, and security settings.
• As an experienced technical MES engineer, support more junior MES engineers and enable a safe environment for collaboration, growth & development, transparent & respectful discussions, and innovative solutions.
• Perform other duties as assigned.
• Logbook & Batch Record Templates, plus Tech Transfer Support:
• Design, build, and test templates for use as Electronic Batch Records (EBRs) and/or Electronic Logbooks (eLogs).
• Develop template design best practices in partnership with Manufacturing and Science Technology (MSAT), Manufacturing (MFG), and Quality Assurance (QA), with the goal of creating well-designed, consistent EBR templates.
• Support improvements to the template design, build, and test strategy.
• Assist business stakeholders & clients in understanding MES requirements during tech transfer projects, including change management, template build timelines, and client involvement.
• As needed, participate in both internal and external meetings as a technical subject matter expert (SME) and representative for the MES team.
• System Governance & Upgrades/Maintenance:
• Support the TSO (Technical System Owner) for Apprentice Tempo MES.
• As needed, support the drafting and development of business use cases, feasibility studies, project charters, and plans.
• Help business users (end users) comprehend the required involvement and workload that will enable a successful project. These projects can include implementation of new functionality such as additional system integrations with Apprentice.
• Support Apprentice upgrade(s) each year for multiple sites.
• Quality Culture & Documentation:
• Create and update documentation associated with MES activities, including but not limited to: SOPs and training content in Veeva, knowledge articles & standard change templates in ServiceNow, checklist templates & test protocols in Kneat, QMS activities such as deviation investigations, CAPA implementations, & change control implementations.

Requirements:

• 4-6 years direct experience working on MES in Life Science GxP Manufacturing.
• Proven experience working within MES teams, which can include a mix of both full-time employees and consultants.
• Strong technical writing, communication, and presentation skills.
• Direct experience supporting project managers develop realistic project plans and timelines.
• Self-motivated, self-managing, detail-oriented; proven capability to work independently on multiple projects and manage priorities.
• Direct experience writing and executing CAPAs, initiating and investigating deviations, and executing or supporting change controls.
• Experience designing, building, and testing EBRs and eLogs.
• Experience supporting MES system upgrades and integrations, which includes taking on technical lead functions for areas within the project.
• Direct experience with troubleshooting MES-SAP interface issues and a strong understanding of how most MES-SAP interfaces are designed, especially for batch and material inventory management.
• Understanding of biologics manufacturing, or batch manufacturing, operations and how MES supports manufacturing operations.

 Nice-to-Haves (Preferred Qualifications):

• Experience supporting Apprentice Tempo MES system upgrades and integrations.
• Experience with designing, building, and testing Apprentice Tempo MES batch and procedure templates.
• Experience with MES integrations with CMMS, LIMS, EDMS, QMS, PCS or SCADA, and historian.
• Experience with using Veeva, Kneat, and ServiceNow.
• Familiarity with ITSM and SDLC principles and methodologies.

The budgeted range for this position is $125,000-$165,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. 

The Role:

ElevateBio is seeking an Automation Engineer II to play a key role in owning the BaseCamp facilities controls and automation systems. This role develops support models to ensure reliable operations, manages vendor and software support contracts, and provides technical support for manufacturing, quality, and research automated systems. The Automation Engineer II supports capital projects and facility expansions, ensures new assets are integrated into the automation infrastructure, troubleshoots manufacturing equipment, and partners closely with Quality and Validation to ensure compliance and system readiness.

Success in this role requires strong system ownership, collaboration, and a customer focused mindset. The ideal candidate brings strong technical expertise in facility controls and infrastructure such as BMS, BAS, BacNet, and MTPS; automation systems including SCADA, PLCs, HMIs, and data historians; and regulatory requirements such as 21 CFR Part 11, Annex 11, and data integrity. A passion for learning, attention to detail, and hands on problem solving are essential. Robust, lean automation and data collection are critical to supporting ElevateBio’s strategy to rapidly launch next generation cell and gene therapies for patients.

 Here’s What You’ll Do:

• Manage control and automation systems projects through the entire project life cycle and ensure that systems are maintained in compliance state after go live.
• Work hand in hand with Facilities, Engineering, MSAT and Operations teams to support their projects and operational needs
• Troubleshoot issues with facilities control systems, automation systems or related infrastructure to ensure and improve manufacturing performance (e.g. yield improvements, etc.) while maintaining all those systems in compliance with cGMPs.
• Provide configuration, development, and break/fix day-to-day support of automation systems.
• Manage automation system documentation and SOPs, prepare technical and user documentation, and conduct system training
• Lead automation-related investigations into Quality Event Reports and implement the necessary corrective actions.
• Lead system maintenance and manage automation life cycle (review application patching, document test plans, and execute test scripts)
• Coordinate with business users for development of reports (batch, material, audit trails, etc.) to support efficient operations.
• Manage automation contractors supporting projects, day-to-day systems operations, planned and unplanned maintenance activities and ensure they comply with safety and quality systems.

Requirements:

• Bachelor’s degree in Engineering, Science, or related technological field
• 6+ years’ experience in life-science regulated environment (e.g. FDA) with working knowledge of the regulatory requirements for pharmaceutical applications  
• 4+ years’ experience integrating/interfacing equipment to control systems via OPC, Ethernet IP, etc.
• Experience with PLCs (e.g. Allen Bradley & Siemens), SCADA (e.g. Ignition), Batch Operations (S88/S95), OSI Soft Pi Historian, BMS/BAS (e.g. Siemens Desigo)
• Control panel and automation hardware and infrastructure design experience
• Demonstrated knowledge of 21CFR Part 11, Annex 11, and GAMP5
• Requires working in an pharmaceutical industrial manufacturing environment including gowning, desired with experience in aseptic operations.