Analytical Development & QC Lead — Clinical & Commercial

Kailera Therapeutics, Inc.; United States; Remote; USD 155,000 - 190,000; Full time

Benefits offered by this job

Health coverage

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics, Inc. is seeking an Associate Director, Analytical Development and Quality Control to lead analytical development and QC activities for Kailera’s pipeline compounds.

The role emphasizes collaboration with cross-functional teams to ensure end-to-end drug development and GMP-compliant manufacturing timelines. The ideal candidate will have peptide chemistry expertise, regulatory filing experience (IND/NDA/MAA), and CDMO oversight, with a strong track record in NDA projects and

Qualifications

• Bachelor's degree in Analytical Chemistry with 10+ years in pharma/biotech or an advanced degree with 5+ years
• Knowledge of peptide chemistry and impurity control strategies
• Experience in setting commercial specifications and NDA experience
• Experience with cGMP, quality systems, and global regulatory requirements

Responsibilities

• Lead analytical development and support QC for clinical development and commercialization.
• Develop and maintain analytical methods and control strategies for peptide drug substances.
• Collaborate with CDMOs for analytical transfers and troubleshooting.
• Contribute to regulatory filings (IND/NDA/MAA) and CMC strategies.
• Author CMC sections and participate in cross-functional CMC teams.
• Communicate project status to stakeholders and drive decisions.

Skills

Analytical development

Quality control

Cross-functional leadership

cGMP knowledge

Regulatory knowledge

Education

Bachelor's degree in Analytical Chemistry

Advanced degree (MS/PhD) in related field

Tools

HPLC

LC-MS

Statistical analysis

Job description

Kailera Therapeutics, Inc. is seeking an Associate Director, Analytical Development and Quality Control to lead analytical development and QC activities for Kailera’s pipeline compounds.

The role emphasizes collaboration with cross-functional teams to ensure end-to-end drug development and GMP-compliant manufacturing timelines. The ideal candidate will have peptide chemistry expertise, regulatory filing experience (IND/NDA/MAA), and CDMO oversight, with a strong track record in NDA projects and