Principal Scientist, Mixed Modalities, Sterile Product Development

Newyorkbioconnect

Unknown
Base: $169,700.00 - $267,200.00; bonus/equity: eli...
Hybrid
Parenteral formulation and process development
Cgmp industrial background
Drug product composition and process scale-up
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 will provide strategic and technical leadership on program development teams and collaborate across functions to drive defined milestones.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, 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 if applicable; Benefits: Comprehensive medical, dental, vision, retirement, paid holidays, vacation, and sick days

Skills & Requirements

Must-have

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

Nice-to-have

  • Experience with intermediate modalities
  • Alternate delivery technologies knowledge
  • Influencing regulatory strategies
  • Large capital project experience
  • Strong interpersonal and collaboration skills
  • Innovative thinking
  • Professional networking

Key Requirements

  • Ph.D. with 8+ years industry experience or M.S. with 10+ years or B.S. with 14+ years in relevant disciplines
  • Experience developing sterile products for IV, IM, and/or SC routes
  • Demonstrated scientific leadership and external publications/patents
  • Experience with FDA, ICH, and other regulatory requirements for CMC
  • Experience in process scale-up and technology transfer to GMP production
  • Ability to mentor junior scientists
  • US and Puerto Rico residency required

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter