Lead Scientist, Sterile Eyecare Formulations

Actox

Irvine, Northern (CA, KY)

Hybrid

USD 180,000 - 240,000

Full time

7 days ago
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Job summary

AbbVie seeks a Principal Research Scientist II / Associate Director to lead the sterile eyecare formulation and process development from early research through commercialization. You will guide a team of scientists, apply QbD and regulatory insight, and coordinate with CROs/CMOs to ensure robust development and timely submissions.

You will oversee global CMC programs, develop technical documentation, and contribute to strategic lifecycle management.

Qualifications

  • Bachelor's Degree in Science with 16+ years of related work experience.
  • PhD in Science or related field with 8+ years of related work experience.
  • Master’s Degree in Science or PharmD with 14+ years of related work experience.

Responsibilities

  • Provide scientific and technical leadership for sterile liquid dosage-form development and eyecare products.
  • Plan, direct, and execute formulation and process-development strategies for clinical trials and commercialization.
  • Develop and maintain knowledge of global CMC submission requirements and GLP/GMP expectations.
  • Advance scientific excellence through reports, publications, regulatory filings, and patents.
  • Collaborate with CROs/CMOs and manage outsourced development activities.
  • Represent the department on CMC and project teams to achieve objectives.
  • Interpret global CMC regulatory requirements for development programs and submissions.
  • Lead, coach, and develop direct reports and promote safety and collaboration.

Skills

Scientific leadership
Quality by Design
Experimental design
Statistical analysis
Regulatory knowledge
CRO/CMO coordination
Team leadership

Education

Bachelor’s Degree in Science related field
Master’s Degree in Science or PharmD
PhD in Science or related field

Tools

JMP

Job description

AbbVie seeks a Principal Research Scientist II / Associate Director to lead the sterile eyecare formulation and process development from early research through commercialization. You will guide a team of scientists, apply QbD and regulatory insight, and coordinate with CROs/CMOs to ensure robust development and timely submissions.

You will oversee global CMC programs, develop technical documentation, and contribute to strategic lifecycle management.

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