Director, Analytical Development & QC - Hybrid
OpenKrill
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Job summary
Kailera Therapeutics, Inc. is seeking a Director of Analytical Development and Quality Control to lead analytical strategies for sterile parenteral products.
The role requires deep experience in method development, validation, regulatory submissions, and cross-functional leadership to enable NDA approvals and product launches. The position offers on-site hub work in Waltham, MA or remote/home-based work with periodic in-person presence, with a strong emphasis on regulatory science and
Qualifications
- 10+ years in pharmaceutical/biotech with CMC regulatory filings experience.
- Strong analytical chemistry knowledge including method development and validation.
- Experience leading CROs/CMOs and external analytical activities.
Responsibilities
- Lead analytical development, control strategy, and lifecycle management for sterile injectable products.
- Define NDA Module 3 content and analytical data packages for regulatory submissions.
- Ensure compliant analytical programs per FDA, ICH, USP/EP/JP/CHP expectations.
- Provide analytical leadership for product characterization, stability, and QA collaborations.
- Oversee external laboratories and partners, drive analytical readiness for milestones.
- Collaborate across manufacturing, regulatory, quality, and CDMOs for tech transfer.
- Lead risk assessment, issue resolution, and continuous improvement of methods.
Skills
Education
Job description
Kailera Therapeutics, Inc. is seeking a Director of Analytical Development and Quality Control to lead analytical strategies for sterile parenteral products.
The role requires deep experience in method development, validation, regulatory submissions, and cross-functional leadership to enable NDA approvals and product launches. The position offers on-site hub work in Waltham, MA or remote/home-based work with periodic in-person presence, with a strong emphasis on regulatory science and
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