Radiopharmaceutical QC Lab Supervisor - Lead & Develop Team

SOFIE; Totowa (NJ); On-site; USD 115,000 - 125,000; Full time

Job summary

SOFIE in Totowa, NJ, seeks a hands-on QC Laboratory Supervisor for Radiopharmaceutical Contract Manufacturing. The role oversees the QC lab and chemist team, ensuring timely analyses of radiopharmaceuticals under 21 CFR 211 and Eudralex Volume 4, aligned with SOFIE's QA program.

You will train staff, manage performance, and collaborate with production and project groups to prioritize work, while maintaining safety and regulatory compliance across shifts.

Qualifications

• Bachelor's degree in chemistry or natural science; 8+ years in analytical chemistry and instrumentation.
• Master's degree with 6+ years preferred and 2-4 years supervision experience.
• Experience in GMP manufacturing environment is highly preferred.
• Knowledge of cGMP requirements, aseptic processing and equipment qualification.
• Excellent organizational and communication skills.

Responsibilities

• Lead laboratory and team with emphasis on Safety, Quality, and Right First Time for product release.
• Train new hires and existing staff on testing methods and instruments.
• Conduct performance reviews and mentor team members.
• Coordinate priorities with production and project management to meet timelines.
• Perform QC analytical tests and batch record review for radiopharmaceuticals.
• Lead analytical method validation activities and QMS-related projects.
• Audit readiness through internal, customer, and regulatory audits.

Skills

Leadership

Quality assurance

GMP knowledge

Lean Six Sigma

Training / mentoring

Safety focus

Team management

Education

Bachelor's degree in chemistry or natural science

Master's degree (preferred)

Tools

Thin layer chromatography

GC

HPLC

Preparative HPLC

Radiometric detectors

Endotoxin testing

MS Office

Job description

SOFIE in Totowa, NJ, seeks a hands-on QC Laboratory Supervisor for Radiopharmaceutical Contract Manufacturing. The role oversees the QC lab and chemist team, ensuring timely analyses of radiopharmaceuticals under 21 CFR 211 and Eudralex Volume 4, aligned with SOFIE's QA program.

You will train staff, manage performance, and collaborate with production and project groups to prioritize work, while maintaining safety and regulatory compliance across shifts.