Sr. Specialist, QC Microbiology (PCR, endotoxin and sterility)

Scorpion Therapeutics; Harvard (MA); On-site; USD 125,619,000 - 152,211,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

Disability insurance

Paid time off

Vacation/holidays

Job summary

Scorpion Therapeutics in Devens, MA is seeking a QC Senior Specialist to support QC microbiology testing for release of clinical and commercial cell therapy products. You will interface with multiple groups, independently perform tasks, interpret results, troubleshoot, and assist with assay transfer.

The role may lead projects, train analysts, and support CAPA, investigations, and deviations; on-call or weekend coverage may be required.

Qualifications

• Bachelor's degree in Science or related field.
• 4+ years in a regulated GMP environment.
• Experience in a GMP laboratory, preferably with cell therapy products.
• Aseptic technique knowledge and practice required.
• Hands-on microbiology experience incl. PCR, endotoxin and sterility testing.

Responsibilities

• Perform compendial verification, method transfer/validation, and routine testing of in-process, final product, and stability samples.
• Apply scientific principles and proper lab equipment use for Sterility, Bioburden, Endotoxin, and Environmental monitoring.
• Anticipate and troubleshoot problems.
• Train new analysts; become a qualified trainer on assigned assays and document training per procedural and cGMP requirements.
• Support document revision, project, CAPA, and investigation/deviation tasks; perform assigned tasks within CAPA/deviation/project.
• May lead projects and continuous improvement efforts.
• Support QC/manufacturing operations, including possible on-call/shift/weekend coverage.

Skills

GMP lab experience

Aseptic technique

Microbiology testing

PCR

Endotoxin testing

Sterility testing

Technical writing

Cross-functional teamwork

Education

Bachelor's degree

Tools

LIMS

Job description

Job Summary

QC Senior Specialist for QC Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. Supports Quality Control microbiology testing for release of clinical and commercial cell therapy drug product, including interfacing with multiple groups, independently performing tasks, interpreting results, troubleshooting, assisting with training and assay transfer.

Shift/Days/Hours

Sunday to Wednesday, 2:00 p.m. to 12:00 a.m.

Job Responsibilities

• Perform compendial verification, method transfer/validation, and routine testing of in-process, final product, and stability samples.
• Apply scientific principles and proper lab equipment use for Sterility, Bioburden, Endotoxin, and Environmental monitoring.
• Anticipate and troubleshoot problems.
• Train new analysts; become a qualified trainer on assigned assays and document training per procedural and cGMP requirements.
• Support document revision, project, CAPA, and investigation/deviation tasks; perform assigned tasks within CAPA/deviation/project.
• May lead projects and continuous improvement efforts.
• Support QC/manufacturing operations, including possible on-call/shift/weekend coverage.

Qualifications

• Bachelor's degree required (preferably Science).
• 4+ years relevant experience (preferably regulated environment).
• Experience in a GMP laboratory (preferably with cell therapy products).
• Knowledge of aseptic technique.
• Hands-on microbiology experience incl. PCR, endotoxin, and sterility testing.
• Ability to follow/apply Global Regulatory and cGMP requirements.
• Strong technical writing, problem-solving, and communication skills.
• Ability to represent the group on cross-functional teams.
• Working knowledge of LIMS and data analysis systems highly desirable.

Benefits/Compensation

• Devens, MA: $43.84-$53.12 per hour (plus potential discretionary incentive cash/stock).
• Comprehensive benefits (medical, dental, vision, life, disability); FTO (exempt) or vacation/holidays (non-exempt), plus other time-off benefits as eligible.