Associate Director, Analytical Development & QC (Peptide)

Regulatory Jobs; United States; Hybrid; USD 155,000 - 190,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Wellness stipend

Job summary

Kailera Therapeutics is seeking an Associate Director, Analytical Development and Quality Control to drive analytical development and QC for clinical development and commercialization of peptide drug substances. The role partners with cross-functional teams to ensure compliant, efficient development in line with global regulatory plans.

The ideal candidate has a strong background in peptide chemistry, cGMP, and regulatory filings, with leadership experience and the ability to manage external

Qualifications

• Bachelor’s degree in Analytical Chemistry or closely related field with 10+ years in pharma/biotech late-stage development.
• Advanced degree with 5+ years in analytical development or CMC regulatory filings preferred.
• Experience leading analytical development and QC for peptide drug substances and IP/IND/NDA/MAA filings.

Responsibilities

• Lead analytical development and support QC for clinical development and commercialization.
• Develop and maintain analytical methods and control strategies for peptide drug substances.
• Lead analytical method transfers and troubleshooting in CDMO labs.
• Contribute to regulatory filings (IND/NDA/MAA) and CMC strategy.
• Authored CMC sections for global regulatory submissions.
• Coordinate with cross-functional teams to meet CMC program goals.
• Communicate project status to stakeholders and drive decisions.
• Travel to CDMOs/CTLs for tech transfers and oversight.

Skills

Analytical development

Quality control

Cross-functional leadership

Regulatory filings (IND/NDA/MAA)

Project leadership

Communication skills

Problem-solving

Education

Bachelor’s degree in Analytical Chemistry or related field

Advanced degree in Analytical/Pharmaceutical Sciences

Tools

CDMO oversight

Process Validation

Job description

Kailera Therapeutics is seeking an Associate Director, Analytical Development and Quality Control to drive analytical development and QC for clinical development and commercialization of peptide drug substances. The role partners with cross-functional teams to ensure compliant, efficient development in line with global regulatory plans.

The ideal candidate has a strong background in peptide chemistry, cGMP, and regulatory filings, with leadership experience and the ability to manage external