Cell Therapy QC Analytics Specialist (4x10h on-site)

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

Avantages offerts par ce poste

Short-term incentive bonuses

Equity-based awards

Retirement programs

Paid time off

Résumé du poste

AstraZeneca plc in Rockville, MD is seeking a Specialist, QC Analytical, to support cGMP lot release and stability for cell therapy products. You will execute approved methods such as flow cytometry, ELISA, PCR, and cell-based assays with a focus on data integrity.

The role is 4 days per week, 10 hours per day, Sunday through Wednesday, on-site in a lab. You will maintain documentation, contribute to investigations, support CAPAs, and collaborate cross-functionally to ensure on-time product

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 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, and maintain a positive, solutions-oriented attitude to drive outcomes.
• Ability to work on-site in a lab-based role for the assigned shift.

Responsabilités

• Analytical testing: Execute QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell based assays, 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: Maintain accurate, contemporaneous records in relevant electronic systems and forms; author/review SOPs and test methods, ensure readiness for internal/external audits and regulatory inspections.
• Quality systems: Participate in 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 and maintain analyst proficiency; 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.

Connaissances

Flow cytometry

ELISA

PCR

Cell counting

Viability

Cell culture

Formation

Bachelor’s degree in Biological Sciences / Chemistry / Biochemistry

Description du poste

AstraZeneca plc in Rockville, MD is seeking a Specialist, QC Analytical, to support cGMP lot release and stability for cell therapy products. You will execute approved methods such as flow cytometry, ELISA, PCR, and cell-based assays with a focus on data integrity.

The role is 4 days per week, 10 hours per day, Sunday through Wednesday, on-site in a lab. You will maintain documentation, contribute to investigations, support CAPAs, and collaborate cross-functionally to ensure on-time product