Associate Director, Analytical Development, Quality Control

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee analytical development and assist QC activities pertaining to the development and commercialization of peptide drug substances.

• Cultivate and sustain up-to-date knowledge in analytical methodologies and product/process control strategies that support peptide drug substances.

• Lead the development of analytical methods via our external network, supporting Kailera’s product pipeline, which includes analytical transfers and troubleshooting within CDMO laboratories.

• Contribute to the creation and implementation of analytical development strategies, managing the execution of functional activities in support of clinical development, regulatory submissions (IND/NDA/MAA), product approvals, and commercialization efforts.

• Draft relevant CMC sections to facilitate global regulatory submissions.

• Engage with cross-functional CMC teams for assigned projects to ensure proper development and execution of CMC plans/strategies as required.

• Relay CMC project updates to key stakeholders across functions and aid in the decision-making process.

• Collaborate with various cross-functional lines to ensure that CMC and program objectives are achieved.

• Travel to CDMOs and other service providers as necessary for vendor technology transfers and oversight of analytical activities.

⛳️ Requirements

• A bachelor’s degree with over 10 years of experience in the pharmaceutical/biotech sector, specifically in late-phase drug substance development, NDA submissions, PAI readiness, and commercial launch in alignment with global CMC regulatory submissions (IND/NDA/MAA, etc.).

• Alternatively, an advanced degree with a minimum of 5 years of experience.

• Proficient knowledge of peptide chemistry along with a solid understanding of peptide degradation pathways and impurity control strategies. Experience in the analytical support of drug substance PPQ/Process Validation is required.

• Proven leadership in analytical projects and active participation in cross-functional teams.

• Experience in establishing commercial specifications.

• Experience in drafting regulatory documents, including NDA submissions.

• Comprehensive knowledge of drug development processes concerning cGMP, quality systems, global regulatory standards, and USP, EP, JP, and CHP requirements.

• Strong grasp of all applicable ICH guidelines.

• Experience with method validation.

• Oversight experience of analytical activities at CDMOs and/or CTLs.

• Excellent problem-solving skills with a capability for technically informed decision-making.

• Strong written and verbal communication skills, along with effective interpersonal abilities.

• An innovative team player with a high energy level suitable for our dynamic company environment.

🏝️ 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