Head of QC Analytics & 7-Day Lab Operations

ElevateBio; Waltham (MA); On-site; USD 165,000 - 225,000; Full time

Job summary

ElevateBio in Waltham, MA seeks an Associate Director, QC Analytics to lead seven-day GMP analytical testing operations. You will drive release and in-process testing, ensure lab excellence, and deliver timely, compliant results while partnering with QCAT for method transfer and lifecycle improvements.

You will manage a team of managers, align capacity, and promote safe, inspection-ready lab practices with right-first-time performance and data integrity at the core of every decision.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Chemistry, Molecular Biology, Pharmaceutical Sciences, or related discipline; advanced degree preferred.
• At least 10 years of GMP Quality Control or analytical lab leadership experience.
• Proven leadership of routine GMP testing supporting product release in biotech/pharma.
• Ability to improve schedule reliability, laboratory flow, and capacity via daily management and problem solving.
• Strong knowledge of cGMP controls, data integrity, investigations, CAPAs, and change control.
• Experience with analytical technologies used in advanced therapies (molecular methods, flow cytometry, immunoassays, chromatography, cell-based assays).
• Experience interfacing routine testing with analytical lifecycle or tech teams (transfer, qualification, validation, equipment qualification, digital lab).
• Experience with LIMS, CDS, ELN, SDMS, QMS, CMMS, ERP or related systems.

Responsibilities

• Own seven-day release, in-process, characterization, and other GMP testing plans.
• Control sample readiness, analyst qualification, instrument availability, testing, review, and result reporting.
• Prioritize and rapidly execute STAT in-process samples with Manufacturing.
• Align sample plans, receipt, and stability pulls with testing schedules.
• Lead safe, compliant lab operations with clear work allocation and standard procedures.
• Drive right-first-time execution and reduce errors through structured problem solving.
• Monitor scheduling adherence, turnaround time, and backlog health.
• Define readiness for operational handoff with QCAT and ensure lifecycle readiness.

Skills

Leadership

GMP knowledge

Quality assurance

Project management

Data integrity

Cross-functional

Problem solving

Education

Bachelor’s degree in Biology or related

Advanced degree preferred

Tools

LIMS

ELN

QMS

CMMS

Job description

ElevateBio in Waltham, MA seeks an Associate Director, QC Analytics to lead seven-day GMP analytical testing operations. You will drive release and in-process testing, ensure lab excellence, and deliver timely, compliant results while partnering with QCAT for method transfer and lifecycle improvements.

You will manage a team of managers, align capacity, and promote safe, inspection-ready lab practices with right-first-time performance and data integrity at the core of every decision.