Senior Scientist - OINDP Formulation & Process Development

Kenox Pharmaceuticals, Inc

Princeton (NJ)

On-site

USD 120,000 - 180,000

Full time

2 days ago
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Job summary

Kenox Pharmaceuticals, Inc in Monmouth Junction, New Jersey is seeking a Senior Scientist II to lead complex pharmaceutical product-development activities across OINDP platforms. The role focuses on nasal sprays, soft-mist inhalation products, nebulized products, DPIs, and drug-device combinations.

You will develop phase-appropriate strategies, mentor staff, and drive cross-functional workstreams through pre-IND to commercial-readiness milestones, ensuring quality and regulatory alignment.

Qualifications

  • Advanced degree in pharmaceutical sciences, chemistry, or engineering is preferred.
  • 7+ years of progressive pharmaceutical-development experience is typical.
  • Expertise in blending and spray-drying for OINDP formulations.
  • Experience with DPIs, nasal sprays, and inhalation products is strongly preferred.
  • Knowledge of QbD, cGMP, GLP, ICH guidance, and FDA expectations.
  • Ability to lead studies, mentor staff, and communicate with senior leadership.

Responsibilities

  • Lead complex product-development programs from concept through tech transfer.
  • Design and optimize blending and spray-drying for peptide-containing formulations.
  • Develop phase-appropriate study plans and risk assessments.
  • Apply QbD to define CPPs, CQAs, and control strategies.
  • Interpret data, identify risks, and propose scientifically sound solutions.
  • Author and review development plans, protocols, reports, and regulatory content.

Skills

OINDP formulation & development
Blending & spray-drying
QbD & risk assessment
Analytical development
Process development
Product performance testing
Technical problem solving
Cross-functional leadership
Regulatory documentation

Education

Advanced degree in pharmaceutical sciences or related field
Bachelor's degree with substantial industry experience
7+ years pharma development experience

Job description

Kenox Pharmaceuticals, Inc in Monmouth Junction, New Jersey is seeking a Senior Scientist II to lead complex pharmaceutical product-development activities across OINDP platforms. The role focuses on nasal sprays, soft-mist inhalation products, nebulized products, DPIs, and drug-device combinations.

You will develop phase-appropriate strategies, mentor staff, and drive cross-functional workstreams through pre-IND to commercial-readiness milestones, ensuring quality and regulatory alignment.

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