Note: The job is a remote job and is open to candidates in USA. Kailera Therapeutics is committed to developing therapies that transform lives and promote overall health. The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of the company's pipeline compounds, ensuring seamless execution of drug development and manufacturing activities.
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
Skills
- 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
- 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
Benefits
- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability and life insurance
- Annual bonus opportunities
- Equity grants
Company Overview