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Director, Analytical Development and Quality Control at kaileratherapeutics - ApplyBlast

Director, Analytical Development and Quality Control

kaileratherapeutics

5 days ago

Waltham, Massachusetts, United States

Hybrid

Full Time

Director

0 applicants

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About this role

The Director, Analytical Development and Quality Control provides strategic and technical leadership for the analytical development, qualification, validation, and lifecycle management of analytical methods for sterile parenteral drug products. This role leads activities to enable successful regulatory submissions, approval, and product launch while ensuring scientific and regulatory rigor. The position requires cross-functional collaboration with internal teams and external partners to support clinical and commercial milestones.

Responsibilities

Lead analytical development and lifecycle management for sterile parenteral products
Define and execute analytical CMC strategies and regulatory submissions
Ensure regulatory compliance and lead technical issue resolution

Skills

Qualifications

Bachelor's degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related fieldAdvanced degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field