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KT
Active4w ago

Associate Director, Analytical Development and Quality Control

Employment

Full-Time

Work mode

Remote

Experience

DIRECTOR

Salary

$155K – $190K/yr

Role overview

Job description

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cro

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What they are looking for

Skills & requirements

Qualification

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. Innovati

Department · Analytical Dev & QC

KT

Hiring company

Kailera Therapeutics, Inc.

View the company profile, current openings and hiring details.

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