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Kailera Therapeutics · 2 days ago

Associate Director, Analytical Development and Quality Control

SD Metro Area

Full-time

Onsite

Lead/Staff, Director/Executive

$160K/yr - $200K/yr

10+ years exp

Kailera Therapeutics is committed to developing therapies that empower individuals to transform their lives and enhance their health. The Associate Director, Analytical Development and Quality Control will oversee analytical development and Quality Control operations to support clinical development and commercialization of the company's pipeline compounds, ensuring compliance and effective collaboration across teams.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Support analytical development and QC activities related to characterization of 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

Oversee and provide scientific leadership on QC testing for DS/DP at vendors, ensuring cGMP compliance, data integrity, and timely delivery of analytical results

Direct investigations including OOS/OOT, deviations, and CAPAs, and provide strong analytical rationale

Design and manage stability programs (accelerated, long-term, bracketing/matrixing) supporting early and late clinical phases

Interpret stability trends and establish shelf-life/retest periods consistent with ICH guidelines and peptide behavior

Support comparability assessments for process changes, analytical method updates, or site transfers

Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making

Participate in cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed

Author and review CMC sections of IND/IMPD and NDA submissions and address regulatory questions

Prepare for audits/inspections and represent analytical and QC functions to regulatory authorities

Lead, mentor, and develop analytical and QC staff while driving continuous improvement and phase-appropriate analytical strategies

Qualification

Analytical techniquesCGMP complianceRegulatory submissionsStability programsOOS/OOT investigationsCross-functional collaborationTechnical writingLeadershipProject managementTeam playerCommunication skills

Required

10+ years of experience, or 5+ with advanced degree, 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.)

Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, dissolution, along with extractables and leachable analysis

Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements

Hands-on experience supporting early- and late-stage CMC development, stability programs, and specification setting

Proven experience leading OOS/OOT investigations, deviations, CAPAs, and change controls

Strong track record of working with CROs/CMOs and managing external analytical/testing activities

Excellent technical writing skills for analytical reports and regulatory submissions (IND/IMPD, NDA/BLA)

Demonstrated leadership ability with experience mentoring and developing scientific staff

Strong communication, cross-functional collaboration, and project-management skills

Innovative team-player with high energy for our dynamic company environment

Preferred

Prior peptide product development including familiarity with peptide manufacturing, characterization, formulation, and stability experience is preferred