Associate Director, Analytical Development and Quality Control

Responsibilities

• Lead analytical development and support QC activities related to the development and commercialization of peptide drug substances.
• Develop and maintain current knowledge in analytical methods and product and process control strategies supporting the peptide drug substance.
• Through our external network, lead the development of analytical methods that support Kailera’s product pipeline, including analytical transfers and troubleshooting in CDMO laboratories.
• Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
• Author relevant CMC sections to enable global regulatory filings.
• Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed.
• Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making.
• Collaborate with cross-functional line functions to ensure CMC and program goals are met.
• Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight.

Requirements

• A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in late phase drug substance development, NDA submissions, PAI readiness, and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.).
• Or an advanced degree with 5+ years of experience.
• Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy.
• Experience in the analytical support of drug substance PPQ/Process Validation.
• Demonstrated analytical project leadership and cross-functional team participation.
• Experience in setting commercial specifications.
• Experience in authoring regulatory documents, including NDA experience.
• Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory requirements, and USP, EP, JP, and CHP requirements.
• Strong understanding of all applicable ICH guidelines.
• Method validation experience.
• Experience with oversight of the analytical activities at CDMOs and/or CTLs.
• Sound problem-solving skills with technically driven decision-making ability.
• Effective written and verbal communication and interpersonal skills.
• Innovative team-player with high energy for our dynamic company environment.

Preferred Qualifications

• Knowledge and experience in analytical development of injectable products, and associated control strategies.
• Knowledge and experience in analytical development of small molecules and solid oral dosage forms.
• Successful support of at least one NDA and commercial launch.
• Synthetic peptide manufacturing knowledge.
• Experience with statistics and applying statistics to analytical chemistry.
• Regulatory Inspection experience.

Education

• A Bachelor’s degree with 10+ years or an advanced degree with 5+ years of relevant experience.
• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.