Director, Quality Control

November 7

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

+1 more states

🏄 California – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

💵 $210k - $235k / year

⏰ Full Time

🔴 Lead

👔 Director

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Jade Biosciences

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Biotechnology • Pharmaceuticals

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

11 - 50 employees

Founded 2024

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Lead critical Quality Control activities to support Jade’s product pipeline across various stages of development • Manage analytical method life cycle including method development, qualification, testing, transfer and validation as phase appropriate • Work closely with internal stakeholders and external CDMO partners • Develop and execute product release testing, stability study and product shelf-life strategy while ensuring full quality compliance with regulatory requirements and internal quality systems

🎯 Requirements

• MS or PhD degree in Chemistry, Biology, Biochemistry, or related field with 10+ years of related experience • 7+ years in Quality Control management for director level within the biotech or pharmaceutical industry • A strong quality compliance and collaborative mindset, and ability to thrive in a fast paced working environment • Strong knowledge of cGMP, FDA, EMA, and ICH regulations • Strong experience in analytical method development including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing • Experience with common analytical techniques such as common compendial methods, HPLC/UPLC, CE-SDS, ELISA, and cell-based assays for biologics development • Proven leadership in managing internal QC operations or external CDMOs • Excellent communication, organizational, and problem-solving skills