Associate Director, Analytical Development and Quality Control

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

The Associate Director, Analytical Development and Quality Control will support analytical development and Quality Control 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)

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