FULL-TIME
Job Description
About the position
As a QC Analyst II on our Cell Therapy Analytical team, you are a vital link in the chain of patient care. You will perform high-precision testing—such as Flow Cytometry and Molecular assays—that confirms the safety and potency of personalized medicines. This role is designed for a detail-oriented scientist who is ready to take more ownership of laboratory operations and provide reliable, high-quality data in a fast-paced environment that bridges the gap between our day and night operations. This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.
Responsibilities
• Perform complex analytical assays to support in-process, lot release, and stability testing. At the Level II stage, you will be expected to perform these tasks with increasing independence.
• Maintain the highest standards of sterility when handling sensitive human biological samples to ensure 100% data integrity and prevent contamination.
• Document results in real-time following Good Documentation Practices (GDP). You will participate in the initial review of data and help ensure the lab remains in a constant state of audit-readiness.
• Identify and escalate results that deviate from expected ranges. You will assist senior analysts and supervisors in "root cause" investigations when technical variances occur.
• Support the lifecycle of the lab by assisting with equipment qualifications, reagent preparation, and the maintenance of a safe, cGMP-compliant workspace.
• Act as a critical communication bridge between day and night operations, ensuring seamless handovers to maintain production momentum.
Requirements
• 1–2 years of experience in a regulated lab environment (GMP/GLP).
• Associate’s or Bachelor’s degree in a Scientific Discipline (Biology, Microbiology, Biochemistry, or related field) is required.
• Familiarity with laboratory computer systems (LIMS) and a strong desire to master complex analytical instrumentation.
• Ability to consistently work the 2nd Shift, 11:00 AM – 9:30 PM, Sunday-Wednesday Schedule. This shift requires a self-motivated individual who can maintain high energy and focus through the afternoon hours.
• An uncompromising commitment to following Standard Operating Procedures (SOPs) and maintaining meticulous records.
Nice-to-haves
• Recent college graduates who have demonstrated exceptional technical aptitude in their academic labs and are eager to launch their careers in a fast-paced industrial setting.
Benefits
• Medical, dental, vision, 401(k), and performance-based incentives.
As a QC Analyst II on our Cell Therapy Analytical team, you are a vital link in the chain of patient care. You will perform high-precision testing—such as Flow Cytometry and Molecular assays—that confirms the safety and potency of personalized medicines. This role is designed for a detail-oriented scientist who is ready to take more ownership of laboratory operations and provide reliable, high-quality data in a fast-paced environment that bridges the gap between our day and night operations. This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.
Responsibilities
• Perform complex analytical assays to support in-process, lot release, and stability testing. At the Level II stage, you will be expected to perform these tasks with increasing independence.
• Maintain the highest standards of sterility when handling sensitive human biological samples to ensure 100% data integrity and prevent contamination.
• Document results in real-time following Good Documentation Practices (GDP). You will participate in the initial review of data and help ensure the lab remains in a constant state of audit-readiness.
• Identify and escalate results that deviate from expected ranges. You will assist senior analysts and supervisors in "root cause" investigations when technical variances occur.
• Support the lifecycle of the lab by assisting with equipment qualifications, reagent preparation, and the maintenance of a safe, cGMP-compliant workspace.
• Act as a critical communication bridge between day and night operations, ensuring seamless handovers to maintain production momentum.
Requirements
• 1–2 years of experience in a regulated lab environment (GMP/GLP).
• Associate’s or Bachelor’s degree in a Scientific Discipline (Biology, Microbiology, Biochemistry, or related field) is required.
• Familiarity with laboratory computer systems (LIMS) and a strong desire to master complex analytical instrumentation.
• Ability to consistently work the 2nd Shift, 11:00 AM – 9:30 PM, Sunday-Wednesday Schedule. This shift requires a self-motivated individual who can maintain high energy and focus through the afternoon hours.
• An uncompromising commitment to following Standard Operating Procedures (SOPs) and maintaining meticulous records.
Nice-to-haves
• Recent college graduates who have demonstrated exceptional technical aptitude in their academic labs and are eager to launch their careers in a fast-paced industrial setting.
Benefits
• Medical, dental, vision, 401(k), and performance-based incentives.
Benefits
- Dental insurance
- Health insurance
Additional Details
- City
- Portsmouth
- State
- New Hampshire
- Country
- US
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