Specialist, Quality Control Analytical, Cell Therapy (Wednesday -Saturday)

AstraZeneca; Rockville (MD); Sur place; USD 81 000 - 121 000; Plein temps

Avantages offerts par ce poste

Short-term incentive bonuses

Equity-based awards

Health, dental, and vision coverage

Paid time off

Résumé du poste

AstraZeneca plc in Rockville, MD is seeking a Specialist, Quality Control Analytical for a 4x10 hour shift (Wed-Sat). You will perform routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products, using flow cytometry, ELISA, PCR, and cell-based assays.

You will operate instruments, maintain documentation, participate in investigations, and contribute to CAPAs.

Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, or related discipline.
• Minimum of 3 years' experience with laboratory techniques relevant to cell therapy or biologics.
• Hands-on experience with flow cytometry, ELISA, PCR, cell culture, cell count/viability, and related assays.
• Ability to work on-site in a lab-based role for the assigned shift.
• Strong cross-functional collaboration and flexible in evolving environment.

Responsabilités

• Execute QC testing for cell therapy products per approved methods and SOPs.
• Operate, calibrate, and maintain instruments; document activities.
• Maintain accurate records; write/review SOPs and test methods; support audits.
• Participate in laboratory investigations and CAPAs.
• Provide peer training and maintain analyst proficiency.
• Coordinate daily testing priorities and communicate testing status.

Connaissances

Flow cytometry

ELISA

PCR

Cell culture

Cell counting

Viability assays

Formation

Bachelor's degree in Biological Sciences

Outils

Flow cytometer

ELISA reader

PCR machine

Description du poste

Specialist, Quality Control Analytical, Cell Therapy

Wednesday - Saturday(4x 10 hour day shift)

Role Overview

Rockville, MD

The Specialist,QCAnalytical, performs routine and non-routine analytical testing to supportcGMP lotrelease and stability of cell therapy products. The role executes approved methods (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high quality and data integrity,maintainsaccuratedocumentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross-functional partners to meet testing timelines and ensure compliant operations.

This positionisfora4days per week, 10 hoursper day shift,Wednesday through Saturday.

Role Responsibilities

Analytical testing:Execute QC testing for cell therapy products (flow cytometry, ELISA, PCR,cell basedassays, cell count/viability) per approved methods and SOPs, meeting cGMP, GDP, and ALCOA+ expectations.

Instrument operation and maintenance:Operate, calibrate, and perform routine maintenance and troubleshooting on relevant instruments; document activities and elevate issues promptly.

Documentation and compliance:Maintainaccurate, contemporaneous records in relevant electronic systems and forms; author/review SOPsandtest methods,ensure readiness for internal/external audits and regulatory inspections.

Quality systems:Participatein laboratory investigations (e.g., OOS/OOT, deviations) by gathering data, performing preliminary assessments, and documenting findings; support implementation of CAPAs and change controls.

Training and knowledge sharing: Complete method qualifications andmaintainanalystproficiency; provide peer training on established procedures as qualified.

Planning and teamwork:Coordinate daily testing priorities, sample receipt, and material control with the team; communicate testing status and risks to ensure on-time lot release.

MinimumRequirements

• Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, or related discipline.

• Minimum of 3years' experiencewithlaboratory techniques relevant to cell therapy or biologics

• Hands-on experience with analytical methods for cell therapy or biologics, including flow cytometry, ELISA, PCR, cell culture, cell count/viability, and functional cell-based assays; familiarity with associated instrumentation and software.

• Demonstrate effective cross-functional collaboration, embrace flexibility in a constantly evolving environment, andmaintains a positive,solutions-orientedattitude to drive outcomes.

• Ability to work on-site in a lab-based rolefor the assigned shift.

The annual base pay (or hourly rate of compensation) for this position ranges from $80,909.60 - $121,364.40.Our positions offer eligibility for various incentives - an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

27-Oct-2026

Closing Date

26-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.