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Kailera Therapeutics · 1 day ago

Director, Analytical Development and Quality Control

Waltham, Massachusetts

Full-time

Hybrid

Director/Executive

$175K/yr - $230K/yr

8+ years exp

Kailera is committed to developing therapies that transform lives and improve health. The Director, Analytical Development and Quality Control will oversee quality control operations throughout clinical development and commercialization, focusing on developing robust QC strategies and ensuring compliance with regulatory expectations.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Develop phase-appropriate QC strategies, procedures (SOPs), and workflows to support QC operations within the CMC team supporting clinical programs from early development through commercialization

Design, implement, and manage stability programs for drug substances and drug products, including protocol development, execution, trending, and reporting

Utilize stability trending and statistical analysis software (e.g., JMP, SLIMStat) to monitor product performance and predict shelf-life

Oversee QC activities at CDMOs and third-party testing sites, ensuring cGMP compliance, data integrity, and timely release and stability testing

Establish robust data management practices for QC, including electronic systems for data capture, trending, and archival, to support regulatory submissions

Ensure QC activities align with integrated development timelines and global regulatory expectations (ICH, USP, EP, JP)

Provide QC support for investigations (OOS/OOT), deviations, CAPAs, and change controls

Prepare for audits and inspections, representing QC to regulatory authorities

Collaborate cross-functionally with CMC, QA, and Regulatory teams to ensure accurate QC documentation (SOPs, CoAs, protocols, reports)

Strong, demonstrated ability to work effectively in teams and collaborate cross-functionally

Perform data verification of regulatory submissions (IND, IMPD, and NDA)

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

Qualification

Analytical techniquesQC strategiesCGMP complianceStability trending softwareRegulatory submissionsLeadershipCross-functional collaborationProject management

Required

Bachelor's degree and 10+ years of experience, or 8+ 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, and dissolution

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 managing QC activities performed at CDMOs and third-party testing sites, with an emphasis on release and stability testing

Experience with stability-trending software

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

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

Demonstrated leadership ability with experience mentoring and developing staff

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

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

Preferred

Prior experience implementing internal QC control strategies supporting development of peptide sterile injectable/combination drug products and small molecule solid oral dosage forms

Prior experience in development QC processes and workflows to enable efficient implementation of QC control strategies and data integrity