Principal Scientist, Mixed Modalities, Sterile Product Development

39med

Base: $169,700.00 - $267,200.00; bonus/equity: eli...
Hybrid (3 days on-site, 1 day remote)
Parenteral formulation and process development
Drug product development under cgmp
Cross-functional team leadership
39med is seeking a Principal Scientist to join their Mixed Modalities team, which develops sterile parenteral drug products. The ideal candidate will have extensive experience in drug product development, particularly in formulation and process development, and will work in a collaborative, multidisciplinary environment

Job Summary

  • The Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms for small, intermediate, and large molecules from preclinical toxicology studies to commercialization.
  • The successful candidate will provide strategic and technical leadership, collaborate across functions to drive milestones, and mentor a small group of scientists.
  • We offer a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, vacation, and sick days.

Matching Summary

Match Score: 85

39med is seeking a Principal Scientist to join their Mixed Modalities team, which develops sterile parenteral drug products. The ideal candidate will have extensive experience in drug product development, particularly in formulation and process development, and will work in a collaborative, multidisciplinary environment.

Salary

Base: $169,700.00 - $267,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive medical, dental, vision, retirement, paid time off

Skills & Requirements

Must-have

  • Parenteral formulation and process development
  • Drug product development under cGMP
  • Cross-functional team leadership
  • Regulatory filings and compliance
  • Process scale-up and technology transfer
  • Quality by Design (QbD) application
  • Mentorship of junior scientists

Nice-to-have

  • Experience with intermediate modalities
  • Knowledge of sterile standards and equipment design
  • Influencing regulatory strategies
  • Strong interpersonal and collaboration skills
  • Innovative thinking and initiative
  • Experience with alternate delivery technologies
  • Global regulatory filing support

Key Requirements

  • Ph.D. with 8+ years industry experience or equivalent
  • Experience developing sterile products for IV, IM, and/or SC routes
  • Strong knowledge of FDA, ICH, and other regulatory requirements
  • Demonstrated scientific leadership and publication record
  • Experience authoring regulatory filings
  • Mentorship experience
  • U.S. work authorization required

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter