Lead, Analytical Development & QC — Peptide Drugs

kailera

United States

Remote

USD 155,000 - 190,000

Full time

14 days+

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Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Annual bonus opportunities

Job summary

Kailera Therapeutics, Inc. is seeking an Associate Director of Analytical Development and Quality Control to drive end-to-end drug development and manufacturing activities.

You will provide technical leadership, collaborate with cross-functional teams, and ensure alignment with integrated development plans and program timelines. The role requires deep expertise in peptide chemistry, cGMP, regulatory filings (IND/NDA/MAA), and external CDMO oversight.

Qualifications

Bachelor’s degree and 10+ years in pharmaceutical/biotech with late phase development, NDA submissions, PAI readiness, and commercial launch per global CMC filings.
Or an advanced degree with 5+ years of relevant experience.

Responsibilities

Lead analytical development and support QC activities for peptide drug substances and their development.
Develop and maintain knowledge in analytical methods and product/process control strategies for peptide drugs.
Lead development of analytical methods via external networks, including transfers and troubleshooting in CDMO labs.

Skills

Analytical development

Quality control

Cross-functional leadership

cGMP knowledge

Regulatory filings

Education

Bachelor's degree in Analytical/Organic/Physical Chemistry, Pharmaceutical Sciences or closely related field

Advanced degree (MS/PhD)

Job description

Kailera Therapeutics, Inc. is seeking an Associate Director of Analytical Development and Quality Control to drive end-to-end drug development and manufacturing activities.

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