Sr. Manager, Packaging & Labeling

Scorpion Therapeutics; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Manager, Packaging & Labeling to design, qualify, and transfer packaging and labeling processes for both clinical and commercial autologous cell therapies, ensuring compliance with global regulatory standards.

You will lead the development of patient-specific labeling strategies, review packaging specs, and oversee cryogenic and temperature-controlled packaging validation, supporting scale-up and network expansion.

Qualifications

• Bachelor's degree in Engineering, Supply Chain, or Packaging Science.
• 5-7 years in labeling, packaging, or artwork management within regulated GMP biopharma environments, ideally with cell/gene therapy experience.
• Knowledge of FDA, EMA, Annex 13, and validation practices (IQ/OQ/PQ).
• Familiarity with cryogenic cold-chain logistics.
• Strong project management and cross-functional collaboration skills.

Responsibilities

• Develop standardized patient-specific labeling strategies.
• Review and validate packaging specifications.
• Oversee validation of cryogenic and temperature-controlled packaging systems.
• Support scale-up and network expansion.

Skills

Labeling

Packaging

Artwork management

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Supply Chain, or Packaging Science

Tools

IQ/OQ/PQ

Job description

Role: Senior Manager, Packaging & Labeling responsible for designing, qualifying, and transferring packaging and labeling processes for clinical and commercial autologous cell therapies, ensuring compliance with global regulatory standards.

Responsibilities

• develop standardized patient-specific labeling strategies
• review and validate packaging specifications
• oversee validation of cryogenic and temperature-controlled packaging systems
• support scale-up and network expansion

Requirements

• Bachelor's degree in Engineering, Supply Chain, or Packaging Science
• 5-7 years in labeling, packaging, or artwork management within regulated GMP biopharma environments, ideally with cell/gene therapy experience
• knowledge of FDA, EMA, Annex 13, and validation practices (IQ/OQ/PQ)
• familiarity with cryogenic cold-chain logistics
• strong project management and cross-functional collaboration skills

High Value

• autologous cell/gene therapy
• cryogenic packaging
• clinical-to-commercial transition
• global regulatory compliance
• GMP validation

Work Setup

remote; no travel specified.