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

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

Résumé du poste

Regulatory Jobs in Rockville, Maryland seeks a QC Analytical Specialist to perform routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (flow cytometry, ELISA, PCR, automated cell counting) with high quality and data integrity.

The position is on-site, four days per week, ten hours per day (Sunday through Wednesday).

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-based assays, 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 escalate 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 culture

Cell counting / viability

Instrument software

Formation

Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline

Outils

LIMS

SOP/documentation software

Description du poste

Job Description

Role Overview

Rockville, Maryland

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,Sunday through Wednesday.

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 **escalate** 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.

Minimum Requirements

• 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, andmaintainsa 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.

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.