Senior Director, Drug Product MSAT - Secondary Packaging

TG Therapeutics, Inc.; Morrisville (NC); Remote; USD 130,000 - 160,000; Full time

Job summary

A biotechnology company is seeking an Associate Director, DP MSAT to oversee secondary packaging and labeling activities. The ideal candidate will have 10-15 years of experience in the biopharmaceutical industry, particularly in managing CDMO relationships and ensuring compliance with cGMP standards. This remote position offers opportunities for collaboration with various internal teams and partners. Candidates must possess strong organizational and communication skills and be willing to travel for partnership engagements.

Qualifications

• 10-15+ years of direct industry experience.
• Demonstrated on-floor experience in secondary packaging operations.
• Understanding of Quality System requirements.

Responsibilities

• Provide technical oversight for labeling & packaging of vials.
• Lead serialization activities according to DSCSA requirements.
• Own artwork change management for new and revised labels.

Skills

Direct industry experience

On-floor experience in secondary packaging

Knowledge of serialization systems

Quality System requirements understanding

Managing CDMO relationships

cGMP requirements understanding

Technology transfer leadership

Regulatory CMC authoring skills

Troubleshooting ability

Communication skills

Education

Bachelor’s Degree in engineering or science

Tools

TraceLink

Job description

A biotechnology company is seeking an Associate Director, DP MSAT to oversee secondary packaging and labeling activities. The ideal candidate will have 10-15 years of experience in the biopharmaceutical industry, particularly in managing CDMO relationships and ensuring compliance with cGMP standards. This remote position offers opportunities for collaboration with various internal teams and partners. Candidates must possess strong organizational and communication skills and be willing to travel for partnership engagements.