Showing 4 jobs
Position Overview
We are seeking a well-versed, highly motivated and detail-oriented Automation Service Engineer to join our team to provide hardware automation expertise and provide the first line of defense to production and engineering teams. In this role, you will be responsible for all instrumentation operating at the highest level of quality and complying with Good Laboratory Practices (GLP).
The successful candidate will be the subject matter expert on all laboratory automation hardware platforms we are building out at Dash. This candidate will be the first line of defense in providing support and troubleshooting together with production automation lead, scientists and technicians as well as the engineering team. You will champion instrument qualifications (plan, execute and document) to ensure all laboratory equipment is best fit-for-purpose and is operating at the highest level required for GxP compliance. This individual will develop and run monthly QCs to ensure instrument’s in-spec performance and to the IQ/OQ standards. You will work with vendors and the quality team to oversee instrument reliability, up time and high operational quality. During periods of increased sample demand, production coverage might be requested.
General Responsibilities:
- Serve as the primary "first line of defense" for real-time automation hardware troubleshooting, error recovery, and system maintenance across production runs.
- Partner with Production Automation Lead, scientists, technicians and engineers to diagnose hardware-software integration issues and minimize operational downtime.
- Coordinate vendor-executed preventive maintenance on all equipment. Collaborate with facilities to ensure up-to-date service contract coverage.
- Author and update automation equipment Standard Operating Procedures and Work Instructions.
- Champion instrument qualifications (draft, execute, and document IQ/OQ/PQ protocols) within a GLP-compliant laboratory.
- Develop the methodology and routinely perform QC on liquid handling platforms to ensure proper instrument performance
- Provide occasional production run coverage and operational support during high-demand processing periods.
Qualifications & Skills
- Automation Platform Expertise: Hands-on technical proficiency with common liquid handling platforms (specifically Hamilton STAR/Vantage instrumentation), alongside Agilent/BioTek devices (i.e.EL406 washer, Synergy NEO) and Thermo Fisher peripherals (i.e. KingfisherFlex and others).
- Biological Workflow Fluency: Familiarity with common laboratory applications and assay preparation, including but not limited to ligand binding assays (ELISA/MSD), genomics (NGS/qPCR/ddPCR), and LCMS.
- Technical Aptitude & Troubleshooting: Strong intuitive grasp of hardware-software integration, logic-based liquid handler tasks, and physical error recovery protocols on active production lines.
- Process & Quality Mindset: Exceptionally structured, detail-oriented, and process-driven. You thrive in regulated (GLP/GxP) environments where data integrity and system uptime are paramount.
- Adaptability & Communication: Clear written and verbal communication skills. Proven ability to prioritize tasks, adapt to shifting priorities, and collaborate effectively across cross-functional science, automation, and software teams.
- Education & Experience: Bachelor’s or Master’s degree in Bioengineering, Biotechnology, Biology, or a related field with 5+ years of hands-on industry experience combined with proven experience managing, configuring, or troubleshooting lab automation in a fast-paced production or clinical setting.
In accordance with Massachusetts pay transparency requirements, the base salary range for this role is $100,000 – $174,000. Actual compensation will vary based on experience, skills, scope, responsibilities, and internal equity. |
On-Site
Full Time
Intermediate or Experienced
$100,000 to $174,000 a year
Job Description
Dash is seeking a qualified, board-certified Laboratory Director on a fractional (contract) basis to direct the laboratory through initial CLIA certification (COC) and maintain compliance thereafter for the High Complexity work completed by the Dash team.. The Director will hold overall responsibility for the laboratory's operation and administration under 42 CFR Part 493, Subpart M, and will be named as Laboratory Director on the CMS-116 application.The Director will delegate specific duties in writing to qualified personnel but remains accountable for every delegated function.
Key Responsibilities
Duties follow the director standards in 42 CFR 493.1445 (high complexity).
Certification phase (pre-inspection)
- Review and sign the CMS-116 application; serve as the named Laboratory Director with the State Agency or accrediting organization (CAP, COLA, or The Joint Commission).
- Confirm test menu and complexity categorization; identify the specialties and subspecialties to be listed.
- Approve the laboratory's physical plant, environmental conditions, and safety program as appropriate for the testing performed.
- Establish and approve the procedure manual, including the written policy for director on-site visits and how each visit is documented.
- Approve method verification (moderate-complexity FDA-cleared tests) or full validation (modified tests and LDTs) before any patient testing begins.
- Enroll the laboratory in HHS-approved proficiency testing for every regulated analyte.
- Verify personnel qualifications; appoint technical consultant/supervisor, clinical consultant, general supervisor, and testing personnel in writing with defined duties.
- Approve training and initial competency assessment for all testing personnel.
- Lead the laboratory through the initial survey and sign the plan of correction for any cited deficiencies.
Ongoing compliance (post-certification)
- Be on-site at least once every 6 months, with at least 4 months between the two minimum visits, and document each visit with evidence of director activities performed.
- Remain accessible by phone or electronic means to provide consultation as needed.
- Oversee the quality control and quality assessment programs; review QC, calibration, and corrective actions.
- Review proficiency testing results and attestations; direct investigation and corrective action for unsatisfactory results.
- Ensure competency assessment is performed semiannually in the first year and annually thereafter for each testing employee.
- Ensure test reports contain required information and that results are reported promptly and accurately.
- Review and sign new or revised procedures, and complete periodic procedure reviews.
- Ensure the laboratory is prepared for biennial inspections and maintains records for required retention periods.
- Provide clinical consultation to ordering providers on test selection and result interpretation, directly or through a qualified clinical consultant.
Duties may be delegated in writing to qualified personnel; the Director remains responsible for their proper performance. A director may direct no more than five non-waived laboratories.
Qualifications
Candidates must meet at least one pathway below for the laboratory's complexity level, under the personnel rules effective December 28, 2024.
Pathway | High complexity (493.1443) |
Pathologist | Board-certified in anatomic and/or clinical pathology |
MD / DO / DPM | 2 yrs directing or supervising high-complexity testing + 20 hrs director Continuing Education (CE) |
Doctoral degree (chemical, biological, or clinical lab science) | HHS-approved board certification + 2 yrs clinical lab experience + 2 yrs supervising high-complexity testing + 20 hrs director CE |
All experience and training must have been obtained in a CLIA-certified laboratory. Director Continuing Education must cover the director responsibilities and be completed before qualifying.
Accepted HHS-approved boards for doctoral-level directors include ABB, ABCC, ABMM, ABMLI, ABMGG, ACHI, ASCP BOC, and doctoral-level ABFT or NRCC certifications.
Candidates must also:
- Currently direct no more than four other non-waived laboratories, so this role does not exceed the five-laboratory limit.
- If qualifying through the physician pathway, hold an active, unrestricted medical license in Massachusetts.
- Have no CLIA sanctions or exclusions, including the two-year prohibition after directing a laboratory whose certificate was revoked.
Time Commitment
Phase | Est. effort | On-site | Key deliverables |
Certification (approx. months 1–4) | 15 hrs/month | At least one documented visit before the survey; present for the survey if requested | Signed CMS-116, approved procedure manual, verification/validation reports, and delegation letters |
Ongoing compliance | 6 hrs/month | At least once every 6 months, 4+ months apart | Monthly QC/QA review, PT review and sign-off, competency records, visit reports |
Survey and inspection years | As needed | During biennial survey when feasible | Survey readiness review, plan of correction if cited |
The Director will be reachable by phone or email during testing hours, with a response time of 3 business days for routine issues and <1 business day for critical issues such as failed QC or PT.
Hybrid
Part Time
Middle Management
Associate Director Information Technology - Biotech/Pharma
Dash Bio
Job Description
We are seeking an Associate Director of Information Technology to lead Dash's IT function. You will set the strategy for the technology Dash runs on, decide how it is built and supported, and be accountable to the CEO and leadership team for the reliability, security, and compliance of our IT environment: the workstations, networks, and identity infrastructure that connect our employees and our instruments. This is a senior leadership role without direct reports. You will lead through our MSP and vendor partners and through influence across the business, operating at the director level on strategy, budget, governance, and risk while remaining hands-on in the work that matters most.
The reason this matters more here than at a typical company of our size is that Dash is a tech-first bioanalytical CRO, and the coupling between our lab instruments and the Windows workstations that control them is tight. When a workstation drifts out of its qualified state, a study is affected. When identity provisioning breaks, a scientist cannot get to the data they generated. The systems in this role's scope are not conveniences; they are part of how the science gets done and how the record of that science holds up under inspection.
Our IT landscape is currently supported in significant part by an outsourced managed service provider (MSP). As our first full-time IT leader, you will be the single accountable owner for IT at Dash. You will manage the MSP as your execution arm, own the IT roadmap, budget, and vendor portfolio, and set the standards, metrics, and processes that let a lean IT function keep pace with lab expansion, new customers, and increasing regulatory scrutiny. There is no internal IT team today and none is planned in the near term, so success in this role means getting outsized leverage from partners, automation, and strong cross-functional relationships.
Operating in a GxP-regulated environment shapes all of this. Deep familiarity with 21 CFR Part 11 and related expectations for change control, documentation, computerized system validation, and data integrity is a requirement, not a nice-to-have. You will define how IT meets those expectations, partner with Quality to govern them, and represent IT confidently in regulatory inspections and customer audits.
Key Responsibilities
- IT Strategy & Leadership: Lead Dash's IT function and serve as the senior technology advisor to the CEO and leadership team. Build and maintain a multi-year IT strategy and 12 to 18 month roadmap aligned with company growth, lab expansion, and customer requirements. Own the IT budget and forecast, including hardware, software, licensing, and services spend, and report regularly to leadership on IT health, risk, metrics, and progress against plan.
- MSP & Vendor Leadership: Lead our outsourced MSP as Dash's IT execution team, and own the broader IT vendor portfolio, including network, security, and key SaaS providers. Define scope, set SLAs and KPIs, run QBRs, lead negotiations and renewals, and drive accountability. Continuously evaluate the outsourced model and adjust scope and partners as the business scales.
- IT Operations & Service Management: Establish the IT operating model for a lean, partner-delivered function, including intake, prioritization, SLAs, runbooks, and an internal knowledge base. Build documentation and automation that keep Dash from depending on any single person or provider.
- GxP Governance & Change Control: In partnership with Quality, define and govern IT's GxP-aligned change control, documentation, and computerized system validation practices. Ensure IT records and controls support data integrity, regulatory inspections, customer audits, and qualification requirements. Represent IT in inspections and audits, and own remediation of IT-related findings.
- Lab Workstation & Instrument Infrastructure: Set the strategy, standards, and lifecycle approach for the Windows machines that drive our lab instruments and robotics. Partner with Science, Automation, and Quality leadership to qualify, patch, and maintain these systems without disturbing their validated state, and to plan infrastructure for new instruments and lab space. Remain hands-on for complex issues and critical changes.
- Cybersecurity & Risk Management: Own the corporate IT security program, including EDR, patch and vulnerability management, email security, backup and restore testing, and security awareness training. Define IT policies and standards, maintain an IT risk register, and lead incident response planning. Lead IT's role in customer security reviews and audits, and mature the program toward recognized frameworks (e.g., NIST CSF, SOC 2) as customer requirements evolve.
- Infrastructure & End-User Computing: Own the direction of the corporate and lab network (segmentation, VPN, redundant ISP, firewalls, wireless), the Mac and Windows fleet and MDM, and SSO and identity infrastructure, including the IdP, SCIM provisioning, and directory sync. Set standards that make provisioning and offboarding fast, complete, and auditable, and lead major initiatives such as identity platform migrations and network expansions.
- Business Continuity & Disaster Recovery: Own IT business continuity and disaster recovery planning for corporate and lab systems. Define recovery objectives with business stakeholders, ensure backups and failover are tested on a regular schedule, and keep plans current as the environment grows.
- Productivity & SaaS Portfolio: Own the strategy for Google Workspace, Slack, and the broader productivity and SaaS stack. Manage licensing, configuration, integrations, and SaaS spend, and drive automation of repetitive IT processes.
- Cross-Functional Partnership: Partner closely with Engineering, Science, Automation, Quality, and Operations leaders to align IT priorities with business needs. Collaborate with Engineering on cloud (AWS) and lab data infrastructure where it touches IT systems, identity, and security.
Qualifications
- Experience: 12+ years in IT and infrastructure roles, including at least 5 years leading an IT function or site as the senior IT leader. Experience as the first or founding IT leader at a growing company is a strong plus.
- Strategic & Executive Leadership: Proven ability to own an IT function end to end, including strategy, roadmap, budget, policies, and vendor portfolio. Skilled at advising executive leadership, translating technical risk into business terms, and leading through influence with cross-functional peers and external partners rather than direct authority.
- MSP & Vendor Management: Proven track record managing MSPs and IT vendors, including defining scope, setting SLAs, negotiating contracts, and holding partners accountable to their commitments.
- Industry & Regulatory: Experience in biotech, pharma, or a comparably regulated setting governed by GMP, GLP, or GCP requirements. Working knowledge of 21 CFR Part 11, data integrity principles, and computerized system validation (e.g., GAMP 5). Experience leading IT through regulatory inspections or customer audits.
- Technical Depth: Strong technical credibility across the IT stack, with deep Windows workstation expertise required and not substitutable. Experience with mixed Mac and Windows fleets, modern MDM, SSO and identity platforms (Entra experience directly relevant), and segmented networks, VPN, and firewalls. This remains a hands-on role, so you should be comfortable doing the work yourself when it matters most.
- Lab or Instrument Systems: Experience supporting instrument-attached or otherwise specialized workstations is strongly preferred. Comparable experience with production systems where downtime and configuration drift carry real consequences will also be considered.
- Security & Risk: Experience owning a corporate security program, including EDR, patching, vulnerability management, backup and recovery, incident response, and IT policy. Familiarity with frameworks such as NIST CSF or SOC 2, and experience leading responses to customer security questionnaires and audits.
- Cloud: Familiarity with AWS sufficient to partner effectively with Engineering on infrastructure, identity, and security.
- Operating Style: Pragmatic, organized, and biased toward action. A builder who sets direction, gets results through partners, and improves the systems they inherit, while staying close enough to the work to make sound technical calls.
- Education: Bachelor's degree in a technical field preferred; equivalent experience considered. Certifications in security, networking, IT service management, or project management (e.g., CISSP, ITIL, PMP) are welcome but not required.
In accordance with Massachusetts pay transparency requirements, the salary range for this role is $144,000– $244,000. Actual compensation will vary based on experience, skills, scope, responsibilities, and internal equity. |
On-Site
Full Time
First Management
$144,000 to $244,000 a year
We are seeking a mid to Senior level Software Engineer (Full Stack) to develop and maintain software solutions for lab automation and bioanalysis workflows. This role is on-site in Waltham, MA, offering a unique opportunity to work at the intersection of software and physical lab systems. You will work alongside senior engineers to build tools that directly impact drug development, progressing from guided tasks to independently owning end-to-end features.
Key Responsibilities:
- Feature Development: Develop, test, and maintain robust software features across the full stack (Node.js/React).
- Learning & Integration: Understand our lab operations to effectively integrate software solutions with real-world lab instruments and automation hardware.
- API & Backend Support: Architect, implement, and optimize APIs and services to support complex data processing and lab workflows.
- Front-End Execution: Build and refine responsive, intuitive user interfaces for lab scientists using React, ensuring a seamless user experience.
- Data Entry & Integrity: Work with relational databases to ensure data is captured accurately, stored efficiently, and is highly accessible.
- Code Quality: Actively participate in code reviews, write clean and documented code, and contribute comprehensively to unit and integration testing.
- Collaborative Troubleshooting: Independently debug and resolve technical issues in a fast-paced environment, assisting peers when needed.
Qualifications:
- Education: Bachelor’s degree in Computer Science/Engineering or other science/engineering discipline with demonstrated software development experience.
- Experience: 4-10 years of professional software development experience.
- Technical Foundation: Fundamental knowledge of TypeScript and JavaScript.
- Web Frameworks: Exposure to React and Node.js (or similar).
- Database Basics: Familiarity with SQL and relational database concepts.
- Problem-Solving: Strong desire to troubleshoot complex problems and learn new technologies quickly.
- Communication: Desire to work on-site with a cross-functional team of scientists and engineers.
On-Site
Full Time
Entry Level