--- title: 'Project Specialist I, Manufacturing at ElevateBio' canonical: 'https://feeny.ai/job/project-specialist-i-manufacturing-elevatebio-waltham-eszjmk3ff7x7' type: 'job' last_seen: '2026-10-16' --- # Project Specialist I, Manufacturing at ElevateBio - **Company:** ElevateBio - **Location:** Waltham, MA - **Posted:** 2026-09-29 - **Last confirmed live:** 2026-10-16 - **Apply:** https://elevate.bio/about/jobs/6211078004?gh_jid=6211078004 ## Job description ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. ## The Role ElevateBio is looking for a Project Specialist I, Manufacturing that will support aspects of technical documentation, quality records, training, improvement projects and compliance for our manufacturing team and broader facility. In addition to core project specialist responsibilities, this role will own short-term manufacturing scheduling and resource planning, ensuring manufacturing teams are appropriately staffed, trained, and aligned to execute production schedules efficiently. The ideal candidate is detail-oriented, collaborative, and thrives in a fast-paced GMP manufacturing environment. Here’s What You’ll Do Technical Documentation & Quality Support: - Support of quality and technical documentation for manufacturing including Discrepancies and/or Deviations, CAPAs and Change Controls (including initiation, investigation, root cause analysis with cross functional groups and closure) - Generate and revise Standard Operating Procedures (SOPs), batch records and other documents to support manufacturing processes and programs - Support cleanroom operations including cleanroom maintenance and cleaning, and executed batch record and document review, as applicable Scheduling & Resource Planning - Develop and maintain short-term manufacturing schedules, assigning technicians and resources to batch production activities across teams - Partner with the Supply Chain Planner to align on batch schedules, translating production plans into daily and weekly technician assignments - Monitor resource availability and proactively adjust assignments to accommodate schedule changes, absences, and shifting priorities - Maintain visibility into staffing levels across manufacturing teams, identifying gaps and escalating resource constraints as needed - Serve as the primary scheduling point of contact within Manufacturing Technical Operations, ensuring alignment between production schedules and workforce availability Training Coordination & Oversight - Own and maintain the manufacturing training matrix, ensuring technician training records are current and aligned with role requirements - Coordinate onboarding schedules for new manufacturing technicians in partnership with supervisors, ensuring timely completion of required training - Track training completion and qualification status, flagging gaps that may impact scheduling or production readiness - Support delivery of technical and quality training to the manufacturing team and support supervisors in planning requalification and continuing education activities Operational Excellence & Continuous Improvement - Support implementation of Operational Excellence programs driving efficiencies in execution and across the site - Track and report on scheduling adherence, resource utilization, and training completion metrics - Develop and maintain scheduling tools and reports to improve visibility into workforce planning and resource allocation - Identify opportunities to improve scheduling processes, training coordination workflows, and cross-team communication Cross-Functional Coordination - Facilitate communication between manufacturing supervisors, the Supply Chain Planning team, and other stakeholders regarding schedule updates and resource changes - Participate in scheduling and planning meetings, providing input on resource capacity and technician availability - Proactively identify and resolve scheduling conflicts, working collaboratively with supervisors and planners to maintain production continuity - Support project team environment with project deliverables ## Requirements - Bachelor’s degree and at least 3 years of related experience, OR Master’s degree with at least 1 years of related experience. - Experience in a Manufacturing, Technical Operations, or GMP environment. Experience in autologous gene or cell therapy is a plus. - Experience with manufacturing scheduling, resource planning, or workforce coordination - Proficiency in Microsoft Office Suite, especially Excel, for scheduling, tracking, and reporting - Experience working in autologous gene or cell therapy and within a contract manufacturing or client service organization is strongly preferred - Familiarity with manufacturing/quality architectures and systems (e.g. SAP, electronic batch records, Veeva) - Strong attention to detail, time management skills, and ability to work in a fast-paced environment Physical and Environment Requirements: - Ability to stand, walk, bend and stretch for extended period of time - Ability to lift 25-50 lbs - Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE. - Ability to perform routine repetitive motions with use of arms, wrists and hands The budgeted range for this position is $42/hour - $57/hour. 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. ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. ## About ElevateBio ## Company Overview - **One-liner**: ElevateBio is a technology-driven contract development and manufacturing organization (CDMO) that powers the creation of genetic medicines by providing integrated gene editing, process development, and cGMP manufacturing capabilities. - **Entity Type**: Private (Series D – raised $401M in November 2025; total capital raised ~$1.3B) - **Headquarters**: Waltham, Massachusetts, United States - **Founded**: 2017 - **Founders**: Not publicly available ## Core Business - Primary industry: Biopharmaceutical CDMO (cell and gene therapy, gene editing, mRNA therapeutics) - Target customers: Biopharmaceutical innovators (B2B, enterprise) - Mission: “To be the world’s most indispensable advanced therapy technology company, changing how companies operate, how products are created, and how disease is treated.” ## Products & Services - **Gene Editing Tools & Discovery Services**: One of the world’s largest toolboxes of gene editing technologies (e.g., CRISPR enzymes), enabling flexible editing and broad access to the genome. Includes discovery services to move from target to optimized therapeutic candidate. - **Process Development**: Scalable, robust manufacturing process design from preclinical through commercial scale. - **Manufacturing (cGMP)**: Viral vectors, cell therapies, mRNA therapeutics, and lipid nanoparticles (LNP). Multi-modality capabilities with 98% batch success rate. Automated cell therapy manufacturing platform. - **Regulatory Support & Commercialization**: Navigate CMC regulatory strategy from IND through BLA. - **Next-Generation Sequencing / Rapid Analytics**: In-house analytics for quality and characterization. ## Market Standing - **Valuation/Market Cap**: Not disclosed (private company) - **Key Metric**: Total funding ~$1.3 billion (as of Series D close in November 2025) - **Notable Investors/Partners**: Novo Nordisk (multi-target R&D collaboration worth up to ~$1.9B), Amazon Web Services (generative AI for CRISPR discovery), Sartorius (automated cell therapy platform), University of Pittsburgh / Richard King Mellon Foundation ($100M grant for biomanufacturing facility) - **Growth Signals**: CNBC Disruptor 50 in 2021, 2023, 2024, 2025; Fast Company’s 2024 Most Innovative Companies; Boston Globe Top Place to Work (2022, 2023); first genetic medicines manufacturer to achieve ICMC multi-modality certification; opened flagship purpose-built biomanufacturing facility in Waltham, MA; achieved 98% manufacturing batch success rate across cell therapy, viral vector, and mRNA batches. ## Competitive Advantages - **Integrated Model**: Science, process development, manufacturing, and quality operate under one roof – no hand-offs between stages. - **Continuous Technology Investment**: Automation, AI-assisted design, and process innovation embedded as a permanent operating principle to reduce costs and timelines. - **Multi-Modality Expertise**: Covers viral vectors, cell therapies, mRNA, LNP delivery, and gene editing – enabling partners to switch modalities without restarting. - **Proprietary Gene Editing Toolbox**: Acquired Life Edit Therapeutics, adding one of the largest collections of gene editing enzymes and patents. - **Industry-Leading Quality**: ICMC certification across multiple modalities and 98% batch success rate exceed industry standards. ## Strategic Focus - Expand gene editing capabilities and delivery technologies (e.g., LNP in vivo delivery for nuclease editing). - Scale manufacturing capacity through new facilities (Waltham flagship, Pittsburgh site). - Deepen collaborations with pharma (Novo Nordisk) and tech (AWS) to accelerate therapy development. - Apply generative AI to broaden CRISPR discovery for complex monogenic and polygenic diseases. - Establish manufacturing blueprints for novel modalities such as base-edited therapies. ## Why Work Here - **Culture**: Described as a group of “explorers” passionate about constant discovery, new technology, and progress in life-transforming therapies. - **Benefits**: Medical, vision, and dental covered at 90%; low deductible; employer-paid life insurance and disability; 401(k) with 4% match (no vesting); 12 weeks parental leave; competitive PTO; commuter reimbursement; monthly cell phone stipend; fitness reimbursement; access to wellness apps. - **Development**: LinkedIn Learning access, Insights Discovery training, ongoing professional development and manager training. - **Work Environment**: Roles primarily based in Waltham, MA (on-site for manufacturing and lab positions). Hybrid/remote not explicitly stated but likely limited for operational roles. - **Recognition**: Boston Globe Top Place to Work; named to CNBC Disruptor 50 multiple years. ## Sources 1. [elevate.bio](https://elevate.bio/) 2. [elevate.bio/about](https://elevate.bio/about/) 3. [elevate.bio/about/careers](https://elevate.bio/about/careers/) 4. [elevate.bio/about/our-journey](https://elevate.bio/about/our-journey/) 5. [LinkedIn](https://www.linkedin.com/company/elevatebio) ## Other roles at ElevateBio - [Associate I-II, Materials Management (Contract, Multiple Openings)](https://feeny.ai/job/associate-i-ii-materials-management-contract-multiple-openings-elevatebio-7ab57ygke1r8) — Waltham, MA - [Associate Director, Commercial Operations](https://feeny.ai/job/associate-director-commercial-operations-elevatebio-waltham-r8n0qy392tf2) — Waltham, MA - [Validation Engineer I](https://feeny.ai/job/validation-engineer-i-elevatebio-waltham-f3fg51tn31g7) — Waltham, MA - [Engineer II, Facilities](https://feeny.ai/job/engineer-ii-facilities-elevatebio-waltham-5zrypa86rt3a) — Waltham, MA - [Lead Specialist, QA Validation](https://feeny.ai/job/lead-specialist-qa-validation-elevatebio-waltham-hnsk1tcfycb8) — Waltham, MA - [Senior Specialist II, Quality Control Validation](https://feeny.ai/job/senior-specialist-ii-quality-control-validation-elevatebio-waltham-yzs796krkpvh) — Waltham, MA - [Manager, Materials Management](https://feeny.ai/job/manager-materials-management-elevatebio-waltham-aedqw9k69be1) — Waltham, MA - [Production Planner](https://feeny.ai/job/production-planner-elevatebio-waltham-jn17rxf4zmjv) — Waltham, MA - [Associate II, Biomanufacturing](https://feeny.ai/job/associate-ii-biomanufacturing-elevatebio-waltham-r1d6pe26ep73) — Waltham, MA - [Specialist I, QC Logistics (Contract)](https://feeny.ai/job/specialist-i-qc-logistics-contract-elevatebio-waltham-a2dpe7dnxthw) — Waltham, MA