Engineering Structures Elsevier Jobs in Brighton, MA

Harness is the AI Software Delivery Platform company, led by technologist and entrepreneur Jyoti Bansal (founder of AppDynamics, acquired by Cisco for $3.7B). Harness has raised approximately $570M in funding and is valued at $5.5B, backed by leading investors including Goldman Sachs, Menlo Ventures, IVP, Unusual Ventures, Citi Ventures, and more. As AI accelerates code creation, the real bottleneck has shifted to everything after the code testing, deployments, application security, reliability, compliance, and cost optimization. Harness brings AI and automation to this \"outer loop,\" helping teams ship software faster while maintaining security and governance throughout the entire software delivery lifecycle.

Powered by Harness AI and the Software Delivery Knowledge Graph, the Harness Platform applies deep context and intelligent automation across the software delivery lifecycle with governance and policy-driven controls embedded throughout the platform.

Over the past year, Harness powered over 185M deployments, 82M builds, 18T flag evaluations, 8M security scans, 9.1B optimized tests, 3T protected API calls, and helped manage $2.8B in cloud spend enabling customers like United Airlines, Morningstar, and Choice Hotels to accelerate releases by up to 75%, reduce cloud costs by up to 60%, and achieve 10x DevOps efficiency.

With a global team across 14 offices and 25 countries, Harness is shaping the future of AI software delivery and we're looking for exceptional talent to help us move even faster.

Harness is looking for sales champions and leaders who are as passionate about building the next great software company as they are about blowing out their numbers every quarter.

• Exceeding your number- Winning new logos
• Forecasting correctly, communicating clearly, aligning brilliantly with the rest of the team
• Not being afraid of being data driven - including using Salesforce and other tools to track your progress
• Managing full sales cycle from prospect to close
• Collaborating with other teams, including sales engineering and sales development

• A proven track record of driving and closing deals
• Account planning and execution skills
• Ability to sell C-Level and across both IT and business units
• Consistent overachievement of quota and revenue goals with a strong W2 track record
• Understands the value of utilizing a strong sales methodology such as MEDDIC when building pipeline and qualifying opportunities
• Proven consultative sales solution skills, including the ability to articulate a clear, concise return on investment value statement
• Ability to maintain a high level of productivity, manage multiple competing priorities, and work effectively under the pressure of time constraints in a fast-paced, complex, collaborative, and team-oriented environment
• Bachelors Degree or equivalent

This role is based in our Boston, MA office.

• Competitive salary
• Comprehensive healthcare benefits
• Flexible Spending Account (FSA)
• Employee Assistance Program (EAP)
• Flexible Time Off and Parental Leave
• Quarterly Harness TGIF-Off / 4 days
• Monthly, quarterly, and annual social and team-building events
• Recharge & Reset Program
• Monthly internet reimbursement
• Commuter benefits

The OTE for this position is $220,000. Factors that may be used to determine your actual pay rate include your specific skills, experience, qualifications, location, and comparison to other employees already in this role. In addition to the base salary, certain roles may qualify for a performance-based incentive and/or equity, with eligibility depending on the position. These rewards are based on a combination of company performance and individual achievements. A valid authorization to work in the U.S. is required.

Boston, Massachusetts

Capital Planning Construction Administration

Full-Time Hybrid

Project Manager 1 - Construction Administration

Capital Planning

Reports To: Project Manager 3 Construction Administration

Exempt

Grade: 10

This Project Manager 1 position is a member of the MSBA's Construction Administration Team that manages MSBA-funded capital projects from design development through bidding, contract award, construction, commissioning, and project close-out. The Project Manager 1 works with a motivated team reporting to a Project Manager3 for major projects and repair projects. The Project Manager 1 works with public school districts and consultants as part of a MSBA team to ensure conformance with MSBA's policies, agreements, and practices for major projects and repair projects through design development, construction and final audit. The Project Manager 1 will also review district submittals that establish grants for the repair program.

• Monitor project schedules, budgets and scope for major construction and repair projects to ensure compliance with MSBA guidelines and funding agreements, and to track construction progress.
• Review monthly reimbursement requests for major construction and repair projects and recommend eligibility of project costs for reimbursement.
• Report on changes to the schematic design budget through the design development and bidding phases, process budget revisions, and review project cash flow for accuracy and variances.
• Review design development documents and prepare and issue review comments for major projects, identifying any variances to the agreed upon scope identified in the funding agreement.
• Review cost estimates, project scope and budget submittal to establish the grant for repair projects.
• Prepare and review change order documentation including recommendation of change order eligibility on major construction and repair projects.
• Review monthly project reports to understand submittal status, contract compliance, construction progress and identify variances. Utilize this information as well as lead site visits to inform MSBA reporting to the Board of Directors.
• Collaborate with the project team to review and make recommendations to improve MSBA processes and inform best practices for school construction.
• Lead in project meetings addressing project status, funding agreements, amendments and change orders.
• Collaborate with the project team to develop a schedule for the timely submittal of all final documents required for final audit of major construction and repair projects. Coordinate with the project team to resolve any outstanding items required and reconcile and approve the final payment.
• Participate in Capital Planning and Construction Administration subcommittees and procurement committees, on an as needed basis.
• Participate in the preparation, coordination and presentation of materials required for MSBA subcommittee, roundtables and Board of Director Meetings.

• Bachelor's degree in one of the following: project management, construction, architecture, engineering, or a related field.
• Two-to-five years of experience associated with construction, project management, building design or other applicable disciplines.
• Knowledge of construction project administration, contract compliance monitoring, change orders and construction methods.
• Proficiency in Microsoft Office software applications, including Excel, Word, PowerPoint and Outlook.
• Ability to effectively manage multiple tasks, involving complex and varying problems.
• Strong verbal and written communication skills.
• Demonstrated ability to gather, analyze, and present complex technical information in a clear, concise, and understandable manner.
• Ability to work both independently and as part of a team.
• Ability and willingness to travel occasionally to project sites.

$78,425 - $86,267 a year

This job description is intended to be general and will evolve over time. The description is subject to periodic updating. At management's discretion, the employee may be assigned different or additional duties from time to time.

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radio antibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radio antibodies precisely target cancer cells with potent, localized radiation.

In addition to the roles and responsibilities outlined below, we value team members who are eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Location: 50 Milk Street, Boston, MA

Reporting to: Caitlyn Harvey, SVP of Technical Operations

Responsibilities

• Create a strategy and lead the MSAT function through CPI, Phase 3 IND submission, PPQ and CPV (this includes API, Drug Substance, and Drug Product).
• Lead technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Collaborate with the Development Lead to learn and document the process as well as co-author development protocols and development technical reports.
• Responsible for authoring key IND updates and justifications
• Responsible for authoring MVP
• Provide onsite support at the CDMO, develop a training plan for manufacturing operators, and oversee process execution
• Lead investigations to troubleshoot process execution challenges including RCA
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Requirements

• BS and/or MS in Chemical, Biological, or Biomedical Engineering
• 10+ yrs or equivalent combination of education and work experience
• Experience authoring IND sections
• Previous experience with antibody based drug substances and antibody-drug-conjugates
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
• Working knowledge of statistical design of experiments (DoE) and RCA.
• Excellent technical writing skills
• Ability to travel up to 25% of the time
• This is a Hybrid role, in office 2 to 3 days a week
• We are considering Greater Boston based candidates only

Nice to haves:

• Knowledge of radiochemistry
• Understanding of analytical methods such as HPLC, SPR, and cell based assays.
• Experience developing scale down models

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.

About the Role

We’re looking for a Quality Director to lead and evolve our quality function as we scale regulated medical devices that incorporate AI/ML software. This role sits at the intersection of hardware, software, and data science and will be critical in ensuring our products meet regulatory requirements while maintaining development velocity.

You’ll report to the VP of Quality & Regulatory and work closely with Engineering, Regulatory, Clinical, and Operations. The right person for this role is comfortable in a fast-moving environment and knows how to build practical, right-sized quality systems.

What You’ll Do

Lead the Quality Function

• Own and continuously improve our Quality Management System (QMS)
• Lead and develop a small but growing quality team
• Establish KPIs and reporting for executive leadership
• Serve as the quality voice at the leadership table

Ensure Regulatory Compliance

• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR
• Prepare for and lead FDA inspections, ISO surveillance audits, and notified body audits
• Support regulatory submissions from a quality perspective
• Monitor evolving FDA guidance on AI/ML-enabled devices and ensure alignment

Support Product Development

• Embed Design Controls into hardware and software development processes
• Ensure compliance with IEC 62304 for software lifecycle processes
• Oversee risk management activities (ISO 14971), including FMEA and hazard analysis
• Partner with Data Science teams on AI model lifecycle controls (training data management, model updates, change control, performance monitoring)

Post-Market & CAPA

• Oversee complaint handling, MDR reporting, and CAPA processes
• Drive investigations and ensure root cause analyses are thorough and actionable
• Use data trending to proactively identify quality risks

Supplier & Manufacturing Quality

• Establish and maintain supplier qualification and audit processes
• Oversee incoming inspection and production quality controls
• Partner with Operations to ensure scalable manufacturing processes

What you'll do

Experience

• 10+ years in quality roles within medical devices or regulated healthcare software
• At least 3–5 years in a leadership capacity
• Direct experience with FDA inspections and ISO 13485 audits
• Experience supporting both hardware and software products
• Familiarity with AI/ML in a regulated environment strongly preferred

Technical Knowledge

• Deep understanding of:
• FDA QSR (21 CFR 820) and ISO 13485
• ISO 14971 risk management
• IEC 62304 software lifecycle requirements
• Working knowledge of Agile/Scrum environments
• Comfort reviewing technical documentation and working closely with engineers and data scientists

Leadership Style

• Hands-on and pragmatic
• Comfortable operating in ambiguity and growth environments
• Able to push back when needed
• Strong communicator with auditors, executives, and technical teams

Nice to Have

• Experience with Software as a Medical Device (SaMD)
• Background in AI/ML model governance or data quality controls
• ASQ certification (CQE, CMQ/OE, etc.)
• Prior experience in venture-backed or scaling organizations

*2nd shift, 3-11pm*

Job Summary

The Manufacturing Supervisor provides hands-on leadership of second shift GMP manufacturing operations for microbiome Live Biologic Products. This role supervises four contract associates and ensures safe, compliant, and efficient execution of fermentation, harvest, lyophilization, media/buffer preparation, packaging, and suite readiness activities. The Supervisor serves as the primary on-site manufacturing leader during second shift and actively supports floor operations.

Responsibilities

• Supervise second shift GMP manufacturing activities, including fermentation and downstream processing.
• Lead and support four contract manufacturing associates; assign tasks and provide coaching.
• Ensure production suites, equipment, and materials are ready and compliant.
• Enforce cGMP, safety, and quality standards.
• Review batch records and documentation for accuracy and completeness.
• Execute shift schedules to meet production timelines.
• Escalate and support resolution of manufacturing issues, deviations, CAPAs, and change controls.
• Support new processes, SOP implementation, and technology transfers.
• Provide clear shift handovers and communicate production status and risks.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Engineering, or related field preferred.
• 3–6 years of GMP manufacturing experience; prior supervisory or lead experience preferred.
• Experience with fermentation, microbial processing, aseptic techniques, or lyophilization preferred.
• Strong knowledge of cGMP regulations and documentation practices.
• Experience reviewing batch records and supporting deviation management.

W-2 employees only. No 3rd parties.

• 8+ years in Technical Program Management, Digital Transformation, or Engineering Program Delivery.
• 3+ years leading AI/ML or advanced analytics initiatives.
• Experience in regulated industries (Pharma, Biotech, Medical Devices).
• Strong understanding of AI/ML lifecycle and data governance.
• Experience working with enterprise platforms (LIMS, MES, SAP, Veeva, etc.).
• Strong stakeholder management and executive communication skills.

Salary Range: 65k-95k

Title: Materials Management Specialist/Senior Materials Management Specialist

Location: Woburn, MA (on-site 5 days per week)

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role: 

Works under the operations team and in coordination with the Quality Assurance (QA) team to oversee the entire flow of materials, from procurement and inventory control to receipt to storage and distribution. Ensure all materials meet defined specifications and are available for intended use and quantities to support user needs. Provide continuous improvement efforts in purchasing, planning, and warehousing. Key responsibilities include strategic sourcing, inventory optimization, demand forecasting, supplier negotiation, and managing logistics for clinical distribution while reducing waste and costs.

Responsibilities: 

• Develop material strategies, forecasts demand, plans production and inspection schedules, and aligns material flow with business goals.
• Maintains optimal inventory levels, conducts physical counts, investigates discrepancies, and implements lean manufacturing principles.
• Supervises purchasing, inventory, and warehouse activities in a manner consistent with cGMPs.
• Assists Quality Assurance to assign and document the status for all materials used in the development of Vaxess products.
• Implements initiatives to reduce waste, cost efficiencies, and improve financial performance.
• Sources, negotiates, and purchases goods and services, building strong supplier relationships and ensuring quality and reliability.

Qualifications: 

• 2 to 5 years in Material Management or Shipping and Receiving in the Pharmaceutical or Medical Device Industries working in a cGMP Environment.
• Strong understanding of supply chain, logistics, and inventory principles.
• Experience with ERP Systems/SAP preferred.
• Experience with standard cGMP storage requirements for Quarantine, Release and Rejected materials.
• Experience with the receipt, storage, distribution, and shipping of temperature-controlled materials.
• Bachelor’s Degree in a relevant field (Logistics, Biomedical Engineering or Health Care Management and certifications (APICS, ISM) preferred.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to   

Salary range: 60k - 80k

Title: Operations Associate, Facilities

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

Research & development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and

chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to the global vaccine and therapeutic market. Vaxess Manufacturing Tour

Responsibilities

• Provide support for the overall lab environment, ensuring proper functioning of utilities, lab equipment and life
• safety systems
• Perform facility & safety inspections including chemical, biological and universal waste consolidation
• Perform equipment installations, qualifications and calibrations for lab & facility equipment/casework
• Provide support to various facilities administration duties including but not limited to external vendor
• coordination, landlord services, HVAC, plumbing, etc.
• Provide support to consumable, chemical and off-site storage inventories
• Collaborate closely with cross-functional teams to support product development and manufacturing activities
• Maintain necessary certifications DOT, RCRA, Bloodborne Pathogens, etc.

Qualifications

• 2-4 years’ experience as on-site technician working in an industrial R&D, Quality Control or Manufacturing lab
• Highschool Diploma/GED is required, BS in STEM degree is a plus
• Ability to lift 50 Lbs. & work across multiple sites
• Familiarity with Lab standards, compressed gas and laboratory utilities, generators, HVAC, IT & access control
• Familiarity or experience working in GxP, a cleanroom and/or a biomedical laboratory environment
• Excellent time and project management skills and proven ability to meet goals and deadlines
• Demonstrated ability to build, repair and maintain equipment, fixtures and furniture
• Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think
• independently, and work collaboratively in diverse multidisciplinary teams
• Entrepreneurial spirit and drive to positively impact global human health

Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you’re interested in joining the Vaxess team, please submit your CV/resume to

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role

We are seeking a motivated and detail-oriented Research Associate with strong hands-on experience in chromatographic analysis to support QC release and stability testing. The successful candidate will perform routine cGMP QC testing using HPLC methods (RP-HPLC, SEC, IEX), Agilent HPLC systems, and additional supporting assays in a fast-paced, collaborative environment. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Perform routine QC release and stability testing using HPLC methods including RP-HPLC, SEC, and IEX.
• Prepare samples, operate Agilent HPLC systems, verify system suitability, and ensure analyses meet method and specification requirements.
• Execute complementary analytical assays such as UV-Vis, pH, surface tension, and mechanical tests.
• Maintain complete, accurate documentation in compliance with cGMP, ALCOA+, and data integrity requirements.
• Conduct routine instrument care (solvent flushes, column care, daily checks) and assist troubleshooting under supervision.
• Process and review chromatographic data in Agilent OpenLab CDS.
• Support method qualification, validation, and transfer activities by executing protocols and recording observations.
• Maintain calibration, maintenance, and service records for analytical instrumentation.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field with 1–3 years of experience; or a master’s degree with relevant laboratory experience.
• Hands-on experience operating HPLC systems; Agilent systems and OpenLab CDS experience strongly preferred.
• Practical experience with chromatographic techniques including RP-HPLC, SEC, and IEX.
• Experience supporting QC release or stability testing in a GMP/GLP environment.
• Strong attention to detail and ability to follow SOPs precisely.
• Excellent documentation practices and understanding of data integrity.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to

Immediate need for a talented Scientist I. This is a 12+ Months contract opportunity with long-term potential and is located in Waltham, MA, USA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-08545

Pay Range: $ 46-$56 /hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Lead and conduct viral/non-viral vector purification process development and process analytics
• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development
• Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies
• Perform troubleshooting experiments and communicate findings with appropriate working groups
• Maintain industry knowledge and keep abreast of new and relevant technologies
• Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations
• Lead scale-up activities to implement a manufacturing process based on DSP development knowledge
• Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
• Mentor and support junior staff and build a culture of support and collaboration

Key Requirements and Technology Experience:

• Key skills: - Purification experience/ Protein Purification Chromatography
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, - Late-stage purification experience such as design space mapping and process robustness studies
• PhD in Biotechnology, Biochemistry, Chemical Engineering or related discipline or master’s degree with a minimum of 4 years of relevant experience or a bachelor’s degree with a minimum of 6 years of relevant experience
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS
• Significant experience, knowledge and understanding of purification technologies and operations such as:
• Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.
• Protein purification chromatography
• Virus clearance and inactivation
• Familiarity with advanced purification technologies and process analytical technologies
• Familiarity with analytical method transfer, analytical method bridging across organizations
• Experience with process technology transfers and performing gap analyses and risk assessments
• Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development
• Expertise in technical report writing
• Experience in AAV and/or non-viral purification development
• Experience in writing CMC components of regulatory dossiers
• Knowledge of product comparability, target product profile and quality risk assessment activities
• Viral clearance study design and execution
• Late-stage purification experience such as design space mapping and process robustness studies
• Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
• Ability to work under minimal supervision and function within a collaborative, team-oriented environment
• Excellent organization and communication skills
• Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems
• Experience with biophysical characterization
• Experience in continuous manufacturing and process analytical technology
• Experience in mentoring junior staff
• Ability to build and nurture cross-functional relationships
• Ability to communicate and represent group in diverse, multi-functional meetings

Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

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