Principal Scientist, Mixed Modalities, Sterile Product Development

539

Base: $169,700.00 - $267,200.00; bonus/equity: eli...
**
Parenteral formulation and process development
Drug product development expertise
Cgmp industrial background
** The Principal Scientist position at 539 focuses on the development of parenteral dosage forms, requiring a highly experienced candidate to lead and collaborate in a multidisciplinary team. The role involves strategic leadership in drug product development across various modalities and offers competitive benefits as well as a hybrid work 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 studies to commercialization.
  • The successful candidate will provide strategic and technical leadership, collaborate across multidisciplinary teams, and mentor a small group of scientists.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, and vacation.

Matching Summary

Match Score: 75

** The Principal Scientist position at 539 focuses on the development of parenteral dosage forms, requiring a highly experienced candidate to lead and collaborate in a multidisciplinary team. The role involves strategic leadership in drug product development across various modalities and offers competitive benefits as well as a hybrid work 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 holidays, vacation

Skills & Requirements

Must-have

  • Parenteral formulation and process development
  • Drug product development expertise
  • cGMP industrial background
  • QbD principles and DOE studies
  • Regulatory filings and compliance
  • Cross-functional team leadership
  • Process scale-up and technology transfer

Nice-to-have

  • Mentorship of junior scientists
  • Experience with intermediate modalities
  • Knowledge of sterile dosage forms
  • Influencing regulatory strategies
  • Large capital project experience
  • Strong interpersonal and collaboration skills
  • Innovative thinking and initiative

Key Requirements

  • Ph.D. with 8+ years industry experience or M.S. with 10+ years or B.S. with 14+ years
  • Degree in Chemical/Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related discipline
  • Experience developing sterile products for IV, IM, and/or SC routes
  • Strong knowledge of FDA, ICH, and regulatory requirements for CMC
  • Experience authoring regulatory filings
  • Demonstrated scientific leadership and publication record
  • U.S. work authorization required

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter