Principal Scientist, Mixed Modalities, Sterile Product Development

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Unknown
Base: $169,700.00 - $267,200.00; bonus/equity: eli...
Hybrid
Parenteral formulation and process development
Sterile product development expertise
Cross-functional team leadership
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

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 must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment and provide strategic and technical leadership on program development teams.
  • We offer a comprehensive package of benefits including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and compassionate and sick days.

Matching 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.

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 holidays, vacation, and sick days

Skills & Requirements

Must-have

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

Nice-to-have

  • Experience with intermediate modalities
  • Knowledge of non-conventional sterile dosage forms
  • Influencing regulatory strategies
  • Large capital project experience
  • Strong interpersonal and collaboration skills
  • Innovative thinking and initiative
  • Professional networking

Key Requirements

  • Ph.D. with 8+ years industry experience or equivalent
  • Experience with cGMP industrial background
  • Demonstrated scientific leadership with publications and patents
  • Strong knowledge of FDA, ICH regulatory requirements
  • Experience authoring regulatory filings
  • Mentorship experience of junior scientists
  • U.S. work authorization required

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter