Jobs in the United States

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Warmwater Fish Biologist - Fish & Wildlife Biologist 3 (In-Training) - Permanent - 2026-09192
State of Washington
Ephrata, WA
- $4,746 to $7,592 USD / month
WDFW Program- Fish Program – Fish Management Division
Added 4 mins ago
Advancement Business Operations Coordinator
Auburn University
Auburn University, AL
…identifying trends and opportunities for improvement to inform future planning and departmental…
Added 4 mins ago
Lead Engineer - Airports
Olsson
Lincoln, NE · Omaha, NE
Bachelor’s degree in engineering, sciences, construction, planning, landscape architecture or a related area preferred. In lieu of a bachelor’s degree, an associate degree with equivalent…
Added 5 mins ago
Senior Product Manager, Value realization
Humana
Lincoln, NE
…Action (NBA) and to assist with measurement tracking across the program. This is a hands-on execution role that turns the measurement strategy into shipped, trusted reporting by partnering…
Added 7 mins ago
Director, Transformation & Performance Management
RJW Logistics Group
Romeoville, IL
…operational change across the Logistics network. Reporting to the VP Planning & Performance Management, this Director turns executive priorities into initiatives that are delivered,…
Added 9 mins ago
Registered Nurse Clinical Specialty Lead
Ascension
Miramar Beach, FL
Financial security & retirement: employer-matched 403(b), planning and hardship resources, disability and life insurance
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Registered Nurse Cardiovascular
Ascension
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Coordinate seamless care transitions by managing discharge planning and providing specialized education on heart health, medication adherence, and post-procedural recovery.
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Registered Nurse Clinical Lead Specialist Burn ICU
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Managing Director, Healthy Children and Families
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Added 15 mins ago
Senior Director, Community Planning, Real Estate Strategy and Investment Estate and
Robert Wood Johnson Foundation
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Added 21 mins ago
GC
Part Time Instructional Program Specialist - Math Lab
Gavilan College (CA)
Gilroy, CA
- $28.47 to $35.3 USD / hour
- Part-time
This paraprofessional classification provides instructional program support in a variety of areas, primarily in learning-assistance related settings, such as learning labs, study labs,…
Added 22 mins ago
Process Improvement Lead
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Remote, United States
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Added 31 mins ago
Advanced Nuclear Lead Project Manager
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United States
The Advanced Nuclear Lead Project Manager will focus on deployment and execution projects related to GE Vernova’s small modular reactors (SMR). This role will report to the Project…
Added 31 mins ago
Assistant Store Manager
TJX Companies
Atlanta, GA
Benefits include Associate discount; 401(k) match; medical/dental/vision; HSA; health care FSA; life insurance; short/long-term disability; paid holidays/vacation /sick/bereavement/parental…
Added 42 mins ago
Sr. Principal Public Affairs & Advocacy Specialist
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Added 49 mins ago
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Added 1 hour ago
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Financial Planning Associate - Walnut Creek/Alamo/San Luis Obispo (Hybrid)
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- $70,000 to $93,500 USD / year
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Added 1 hour ago
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Added 1 hour ago
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Associate Director of Development Operations
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The Associate Director of Development Operations will build and lead the systems, processes, data infrastructure, and operational practices required to support a high-performing, integrated…
Added 1 hour ago
Manager, Strategic Initiatives & Business Operations
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Added 1 hour ago
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- $39.96 USD / hour
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ElevateBio

Associate Director, QC Analytics

Waltham, MA, United States

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Job details

Experience: At least 10 years of relevant experience in a GMP Quality Control or analytical laboratory environment, including progressive people and operational leadership responsibility.
Posting language: English
Posted: Nov 2, 2026

Original 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

The Associate Director, QC Analytics provides operational leadership for routine GMP analytical testing at ElevateBio’s Waltham site and leads a team of managers responsible for seven-day laboratory operations. This role is accountable for predictable execution of product release and in-process testing, laboratory excellence, right-first-time performance, and timely, compliant reporting of results. The Associate Director leads the testing organization through disciplined capacity planning, daily management, schedule control, performance management, and rapid resolution of operational barriers across the full operating week. The role partners closely with Quality Control Analytical Technologies (QCAT), which provides technical enablement and analytical lifecycle leadership, to ensure new or changed methods, equipment, controls, critical reagents, and digital capabilities transition into stable, sustainable routine operations.

Here’s What You’ll Do

Release Testing Execution

Own the integrated plan for routine release, in-process, characterization, and other assigned GMP testing; align capacity, staffing, instruments, and seven-day coverage to demand.
Use tiered daily management and clear escalation to control sample readiness, analyst qualification, instrument availability, testing, review, and result reporting.
Partner with Manufacturing to prioritize and rapidly execute STAT in-process samples within required decision windows; immediately escalate delays or risks.
Partner with QC Logistics to align sample plans, receipt and chain of custody, contract laboratory dependencies, and stability pulls with testing schedules.

Laboratory Excellence

Lead safe, compliant, inspection-ready laboratory operations with clear work allocation, standard work, trained personnel, and available equipment, reagents, and consumables.
Drive right-first-time execution and reduce repeat work, documentation errors, queue time, and schedule variability through structured problem solving and continuous improvement.
Monitor schedule adherence, turnaround time, right-first-time performance, repeat testing, investigation aging, review cycle time, capacity utilization, and backlog health.

QCAT Interface and Operational Readiness

Partner with QCAT on method transfer, qualification and validation, equipment qualification, controls and critical reagents, lifecycle changes, and Digital QC initiatives.
Define and confirm readiness for operational handoff, including approved methods and specifications, trained analysts, qualified equipment and systems, data workflows, troubleshooting guidance, materials, and sustainable capacity.
Implement QCAT-enabled changes through controlled deployment and post-implementation monitoring, and provide routine-use data and feedback for lifecycle improvement.
Maintain clear accountability: QCAT leads technical enablement and analytical lifecycle activities; QC Analytics owns routine execution and delivery after handoff.

Quality, Compliance, and Investigations

Ensure testing, records, review, and reporting meet cGMP, approved procedures, specifications, quality agreements, data-integrity expectations, and program commitments.
Lead operational response to laboratory events, deviations, atypical or out-of-specification results, CAPAs, change controls, and risks; partner with QCAT and Quality Assurance when technical lifecycle expertise is required.
Represent QC Analytics during audits, inspections, governance meetings, release-readiness reviews, and operational escalations.

People and Organizational Leadership

Lead and develop a team of managers responsible for seven-day laboratory operations and the broader testing organization, with clear objectives, decision rights, coverage expectations, and accountability.
Build qualification, cross-training, succession, resource, and capability plans that support demand and reduce single points of failure.
Create an inclusive, high-accountability culture grounded in safety, quality ownership, transparent communication, and continuous learning.

Requirements

Bachelor’s degree in Biology, Biochemistry, Chemistry, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline; an advanced degree is preferred.
At least 10 years of relevant experience in a GMP Quality Control or analytical laboratory environment, including progressive people and operational leadership responsibility.
Demonstrated leadership of routine GMP testing supporting product release in biotechnology, pharmaceutical, biologics, cell therapy, gene therapy, or another regulated environment.
Demonstrated ability to improve schedule reliability, laboratory flow, right-first-time performance, and capacity utilization through daily management, standard work, metrics, and structured problem solving.
Strong working knowledge of cGMP laboratory controls, data integrity, method execution, specifications, laboratory investigations, deviations, CAPAs, change control, and inspection readiness.
Experience with analytical technologies relevant to advanced therapies, such as molecular methods, flow cytometry, immunoassays, chromatography, and cell-based assays, is preferred.
Experience operating at the interface between routine testing and analytical lifecycle or technical teams, including method transfer, qualification, validation, equipment qualification, and digital laboratory implementation.
Experience with laboratory systems such as LIMS, CDS, ELN, SDMS, QMS, CMMS, ERP, or related platforms.
Strong capacity-planning, prioritization, risk-management, communication, and stakeholder-management skills in a multi-program or CDMO environment.
Proven ability to develop leaders and teams, manage competing priorities, make timely decisions, and communicate clearly with clients, technical partners, Quality Assurance, Manufacturing, and senior leadership.

Physical and Environment Requirements:

Ability to stand, walk, bend and stretch for extended period of time
Ability to lift 15-20 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 $165,000 - $225,000. 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. 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.

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More about this job

Skills

Leadership
Good manufacturing practices
Reporting
Performance management
Quality control
Logistics
Inspection
Documentation
Problem solving
Process improvement
Troubleshooting
Regulatory compliance
Quality assurance
Molecular biology
Biotechnology
LIMS
CMMS
ERP
Prioritization
Risk management
Communication skills
Stakeholder management

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