Associate Director, Analytical Development and Quality Control

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.

 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

 

Responsibilities:

• Support analytical development and QC activities related to characterization of peptide drug substances and drug products from early-stage clinical development through commercialization
• Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
• Support 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
• Support authoring of 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 all phases of innovative drug development 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 is required
• Demonstrated project and cross-functional team participation
• Experience in authoring regulatory documents
• Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
• 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 peptide therapeutics (DS and DP)
• Knowledge and experience in analytical development of injectable products, and associated control strategies

 

Education:

• A Bachelors degree with 10+ years or an advanced degree with 5+ years of relevant experience
• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceut