Analytical Development & QC Lead — Clinical & Commercial
Kailera Therapeutics, Inc.
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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
Education
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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
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