Senior Scientist, Injectables Formulation

Hikma Pharmaceuticals

Cherry Hill Township (NJ)

On-site

USD 67,000 - 134,000

Full time

4 days ago
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Job summary

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ is seeking a Sr. Scientist, Formulation - Injectables to lead formulation and process development for drug products under QbD.

You will design robust DoE studies and guide technical decisions within cross-functional teams to meet project timelines. The role emphasizes collaboration with R&D, Regulatory Affairs, and Operations, with responsibility for staff development, data-driven problem solving, and timely transfer of products to manufacturing

Qualifications

  • Bachelor's or Master's in Pharmacy or related field with 10+ years of experience.
  • Extensive knowledge of parenteral formulation platforms and scale-up of sterile injectables.
  • Strong understanding of FDA regulations and ICH guidelines.
  • Proven leadership and ability to work cross-functionally.

Responsibilities

  • Develops product development strategies aligned to regulatory processes and QbD/QbR requirements.
  • Designs formulation development and associated technical decision making.
  • Develops and executes robust DoEs and interprets statistical data.
  • Collaborates with Operations to incorporate feedback into formulation development.
  • Ensures high-quality submission documents with Regulatory Affairs and RD&E.
  • Leads departmental staff, manages budgets, and reports progress to management.

Skills

Parenteral formulation
Regulatory knowledge
Analytical techniques
Leadership and project management

Education

Bachelor's or Master's in Pharmacy or Pharmaceutical Sciences
PhD preferred

Tools

Microsoft Office

Job description

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ is seeking a Sr. Scientist, Formulation - Injectables to lead formulation and process development for drug products under QbD.

You will design robust DoE studies and guide technical decisions within cross-functional teams to meet project timelines. The role emphasizes collaboration with R&D, Regulatory Affairs, and Operations, with responsibility for staff development, data-driven problem solving, and timely transfer of products to manufacturing

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