Director, Analytical Development & QC (Remote Eligible)

Kailera Therapeutics; Waltham (MA); Hybrid; USD 192,000 - 235,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Wellness stipend

Tuition reimbursement

Commuter benefits

Job summary

Kailera Therapeutics in Waltham, MA seeks a Director, Analytical Development and Quality Control to provide strategic leadership for analytical method development, validation, and lifecycle management supporting sterile parenteral products.

This role drives regulatory submissions and product launch readiness, translating complex data into regulatory strategies and ensuring compliance with FDA and global guidelines.

Qualifications

• 8+ years in pharma/biotech with NDA/MAA experience.
• Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC.
• Knowledge of cGMP, ICH, USP/EP/JP/ CHP regulatory requirements.
• Experience managing CROs/CMOs and external analytical activities.
• Proven leadership and staff development skills.

Responsibilities

• Lead analytical development, control strategy, and lifecycle management for sterile products from development through commercialization.
• Define and execute analytical CMC strategies, regulatory submissions, and NDA Module 3 content.
• Ensure scientifically sound, regulatory-compliant analytical programs and issue resolution.
• Provide analytical leadership for product characterization, stability, and manufacturing support.
• Establish and maintain robust analytical methods and lifecycle management.
• Lead stability and specification strategies across the product lifecycle.
• Integrate analytical, formulation, process, and manufacturing knowledge for technology transfer and oversight of external labs.

Skills

Analytical methods

HPLC/UPLC

LC-MS

cGMP knowledge

Regulatory filings

CRO/CMO management

Leadership

Education

Bachelor's in Analytical Chemistry

MS/PhD in related field

Job description

Kailera Therapeutics in Waltham, MA seeks a Director, Analytical Development and Quality Control to provide strategic leadership for analytical method development, validation, and lifecycle management supporting sterile parenteral products.

This role drives regulatory submissions and product launch readiness, translating complex data into regulatory strategies and ensuring compliance with FDA and global guidelines.