Director, Analytical Development & QC - Parenteral Drugs

Kailera Therapeutics, Inc.

United States

Híbrido

USD 192.000 - 235.000

Jornada completa

Hace 5 días

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Health coverage

Flexible time off

401(k) match

Tuition reimbursement

Annual bonus opportunities

Descripción de la vacante

Kailera Therapeutics, Inc. is seeking a Director of Analytical Development and Quality Control to provide strategic and technical leadership across analytical development, qualification, validation, and lifecycle management for sterile parenteral products.

This role will drive regulatory submissions and readiness for NDA, partnering with QA, Regulatory Affairs, Manufacturing, and external CDMOs. The successful candidate will have 10+ years in pharma/biotech analytics, with strong cGMP knowledge,

Formación

10+ years of experience in pharmaceutical/biotech with involvement in IND/NDA/MAA filings
Strong knowledge of cGMP, quality systems, ICH guidelines, USP/EP/JP/CHP
Experience managing external analytical development and QC activities
Proven leadership with mentoring and developing staff
Excellent communication and cross-functional collaboration skills
Experience supporting NDA submissions and regulatory readiness for sterile parenteral products

Responsabilidades

Lead analytical development, control strategy, lifecycle management for sterile injectables
Define and execute analytical CMC strategies and NDA content
Ensure regulatory-compliant analytical programs and issue resolution
Provide leadership for product characterization, stability, and quality attributes
Oversee external labs and CDMOs, ensuring regulatory readiness for milestones
Support technology transfer, comparability assessments, and change management