Remote Director of External QC & Stability

Centessa

Boston, Northern (MA, KY)

Hybrid

USD 150,000 - 210,000

Part time

2 days ago
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Benefits offered by this job

401(k)
Medical insurance
Dental insurance
Vision insurance
Life insurance
Paid time off
Wellness program

Job summary

Centessa Pharmaceuticals, based in the US, seeks a Director of External Quality Control & Stability to lead analytical testing, stability programs, and specification management supporting clinical and commercial development.

The role requires 10+ years in quality control/analytical development, with a strategic vision for quality control and a track record of regulatory-facing work. This remote US position offers a competitive base salary and comprehensive benefits.

Qualifications

  • BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
  • 10+ years quality control and analytical development experience.
  • Experience developing strategic vision as well as providing tactical support for quality control programs.

Responsibilities

  • Develop and lead analytical quality control strategy across multiple programs.
  • Review analytical methods, specifications, and validation activities for adequacy and collaborate on updates.
  • Support analytical method transfer and supplier qualification activities.
  • Oversee the stability program design and execution across multiple programs.
  • Monitor and report on stability trends and product quality attributes.
  • Ensure regulatory compliance of stability activities and documentation.
  • Provide tactical support for regulatory submissions and inspections.

Skills

Analytical QC strategy
Method transfer
Stability leadership
Regulatory compliance
Regulatory submissions
Audits & inspections

Education

BS in Chemistry
MS in Analytical Chemistry
PhD in Pharmaceutical Sciences

Job description

Centessa Pharmaceuticals, based in the US, seeks a Director of External Quality Control & Stability to lead analytical testing, stability programs, and specification management supporting clinical and commercial development.

The role requires 10+ years in quality control/analytical development, with a strategic vision for quality control and a track record of regulatory-facing work. This remote US position offers a competitive base salary and comprehensive benefits.

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