Eyecare Formulation & Process Leader, Senior Scientist

University of Georgia- FACS

Irvine, Northern (CA, KY)

Hybrid

USD 180,000 - 240,000

Full time

7 days ago
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Benefits offered by this job

Paid time off
Medical/dental/vision insurance
401(k) plan
Long-term incentive programs

Job summary

AbbVie is seeking a Principal Research Scientist II / Associate Director to lead the formulation and process development for sterile eyecare products, guiding projects from early research through commercialization. You will manage a team of scientists in formulation, process development, and analytical-method development, ensuring compliance with GLP/GMP and global CMC requirements.

Responsibilities include directing development strategies, coordinating with CROs/CMOs, and delivering robust

Qualifications

  • Bachelor/Master/PhD with extensive related work experience.
  • Experience in sterile liquid dosage-form development and regulatory readiness.
  • Knowledge of global CMC regulatory requirements, GLP/GMP.

Responsibilities

  • Provide scientific and technical leadership for sterile eyecare product development.
  • Plan and direct formulation and process-development strategies for clinical and commercial products.
  • Develop knowledge of CMC submissions and regulatory expectations; author technical documents.
  • Advance scientific excellence and publish findings; contribute to regulatory filings and patents.
  • Collaborate with CROs/CMOs; manage outsourced development activities and timelines.
  • Represent the department in cross-functional teams; align with regulatory and quality functions.
  • Interpret current global CMC requirements and respond to health-authority questions.
  • Lead, coach, and develop direct reports; promote safety, rigor, and collaboration.

Skills

Leadership
Regulatory knowledge
Quality by Design
Statistical design
Technology transfer
Team collaboration

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 is seeking a Principal Research Scientist II / Associate Director to lead the formulation and process development for sterile eyecare products, guiding projects from early research through commercialization. You will manage a team of scientists in formulation, process development, and analytical-method development, ensuring compliance with GLP/GMP and global CMC requirements.

Responsibilities include directing development strategies, coordinating with CROs/CMOs, and delivering robust

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