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Jade Biosciences · 2 months ago

Director, Quality Control

Boston, Massachusetts, United States

Full-time

Onsite

Director/Executive

$210K/yr - $235K/yr

7+ years exp

Jade Biosciences is focused on developing innovative therapies for autoimmune diseases. The Director of Quality Control will lead critical Quality Control activities to support the product pipeline, managing analytical method life cycle and ensuring compliance with regulatory requirements.

Health CareTherapeutics

Responsibilities

Work with both internal (other CMC functions, Quality Assurance, Regulatory and other key stakeholders) and external CDMO partners to develop and implement QC strategies appropriate for different phases of development programs

Oversee batch release and stability testing, method development, qualification, transfer and validation activities at and cross CDMOs

Develop product specifications and oversee product in-process, release, and stability testing strategy and execution in compliance with both cGMP and ICH guidance and internal quality standard

Work with Quality Assurance to create and manage QC documentation including SOPs, protocols, and technical reports

Collaborate cross-functionally with other CMC functions, QA and Regulatory to support tech transfers and lifecycle management, regulatory filing and interactions etc

Manage CDMO relationships to ensure compliance with quality standards, timely deliverables, and effective communication

Review and approve CDMO generated data, investigations, and documentation

Ensure timely investigation and resolution of OOS results, deviations, and CAPAs

Serve as QC subject matter expert during regulatory inspections and audits

Qualification

Quality Control managementCGMP knowledgeAnalytical method developmentFDA regulationsICH regulationsHPLC/UPLCCommunicationOrganizational skillsProblem-solving skills

Required

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