What You’ll Do:

The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.

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.

Required Qualifications:

• 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
• 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.

Additional Information:

• This position requires some travel to domestic and international destinations.
• In rare occasions, this position may require working in environments where there may be specific gowning or dress code requirements.