Associate Principal Scientist, Engineering- Biologics, Sterile Drug Product Commercialization

med-in.at

Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid
Drug product process development
Process scale-up and technology transfer
Sterile drug product manufacturing
The Sterile Drug Product Commercialization group provides technical leadership and laboratory capabilities for late-stage and commercial biologics drug product processes, including process scale-up, technology transfer, and process validation

Job Summary

  • The Sterile Drug Product Commercialization group provides technical leadership and laboratory capabilities for late-stage and commercial biologics drug product processes, including process scale-up, technology transfer, and process validation.
  • The Associate Principal Scientist will drive excellence in process characterization, scale-up, transfer, and validation activities while leading cross-functional teams and supporting regulatory submissions and manufacturing investigations.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, vacation, and supports a hybrid work model for office-based U.S. employees.

Matching Summary

The Sterile Drug Product Commercialization group provides technical leadership and laboratory capabilities for late-stage and commercial biologics drug product processes, including process scale-up, technology transfer, and process validation.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation

Skills & Requirements

Must-have

  • drug product process development
  • process scale-up and technology transfer
  • sterile drug product manufacturing
  • process validation and characterization
  • regulatory submission authoring
  • cross-functional team leadership
  • commercial biologics product launch

Nice-to-have

  • mentorship and technical oversight
  • innovation and continuous process optimization
  • experience with Quality by Design principles
  • data analytics and computer modeling
  • diversity and inclusion culture
  • excellent oral and written communication

Key Requirements

  • B.S. with 10 years or Master's with 8 years or Ph.D. with 4 years relevant experience
  • experience in biologics drug product manufacturing and fill finish
  • knowledge of cGMP and ICH quality norms
  • experience with regulatory filings and CMC sections
  • ability to travel up to 25%
  • U.S. work authorization or visa sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter