# Manager Quality Control Analytical (Wednesday - Saturday)

**Company**: Quality Control, Cell Therapy Facility
**Location**: Rockville, Maryland
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Salary**: The annual base pay (or hourly rate of compensation) for this position ranges from $112,604.80 - $168,907.20.
**Category**: Scientific Research
**Industry**: Biotechnology

**Apply**: https://astrazeneca.eightfold.ai/careers/job/563877690605264?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f624d67e-645

## Description

Manager, Quality Control Analytical, Cell Therapy

The Manager, QC Analytical, provides managerial, operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability testing. The role focuses on right-first-time analytical assay execution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) and end-to-end laboratory readiness, including people and equipment oversight.

Responsibilities:

- Laboratory operations oversight: Manage a QC laboratory team and day-to-day lab activities including sample intake, scheduling, testing flow and data review.

- Analytical testing: Perform and oversee QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell based assays, cell count/viability) per approved methods, ensuring adherence to cGMP, GDP, and data integrity expectations (ALCOA+).

- Documentation and compliance: Maintain accurate, contemporaneous records in relevant electronic systems and forms; author/review SOPs, test methods, and certificates of analysis; ensure readiness for internal/external audits and regulatory inspections.

- Training and mentoring: Train and coach junior team members on methods, cGMP/GDP, safety, and data integrity; support qualification of analysts and ongoing proficiency assessments.

- Planning and communication: Coordinate testing schedules, sample logistics, and material controls; communicate status and risks; escalate issues proactively to meet lot release timelines.

- Continuous improvement and LEAN: Drive 5S, visual management, standard work, and deviation trend reviews; improve flow and increase right-first-time performance.

Minimum Requirements:

- Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline; advanced degree (MS/PhD) preferred.

- At least 5 years' experience in pharmaceutical/biotech QC with emphasis on laboratory operations/management in a cGMP setting.

- Demonstrated experience operating a QC laboratory in a regulated environment with knowledge of cell therapy specific considerations (e.g., chain of identity/chain of custody, rapid turnaround for patient supply, phase-appropriate controls).

- Proven ability to plan and coordinate laboratory operations, manage competing priorities, and communicate status, risks, and mitigations to cross-functional stakeholders; experience presenting in audits/inspections.

- Hands-on experience with qualification and maintenance of key QC instruments and with lab informatics (LIMS/ELN/LES, instrument data systems); strong command of data integrity controls and computerized systems compliance.

- Ability to design and deliver effective training; mentor analysts on safe, compliant, and efficient lab practices; cultivate a culture of quality and continuous improvement.

- Effective cross-functional partner with Manufacturing, MSAT/AD, QA, Supply Chain, Facilities, and EHS; comfortable operating in a fast-changing environment and adjusting plans to meet patient-critical timelines.

- Ability to work on-site in a lab-based role for the assigned shift.

The annual base pay (or hourly rate of compensation) for this position ranges from $112,604.80 - $168,907.20.

## Skills

### Required
- Cell therapy
- Flow cytometry
- ELISA
- PCR
- Automated cell counting
- Lab informatics
- Data integrity
- cGMP
- GDP
- Regulatory compliance

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Source: [Apply at astrazeneca.eightfold.ai](https://astrazeneca.eightfold.ai/careers/job/563877690605264?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)