Head Of Quality Control (Biologics)

Company:   JOINN Biologics US Inc Location:  2600 Hilltop Dr., Richmond, CA 94806 Posted:  2022-05-31


JOINN Biologics (JOINN Bio) is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry. Director, Quality Control The Director, Head of QC is responsible for overseeing all QC activities for large molecule projects, Manages QC activities (include release testing method transfer and qualification, in-process and release testing data review, stability and environmental monitoring programs, raw material testing) that support GMP manufacturing, testing and release of finished products, applicable International Regulations, ICH guidelines, and JOINN Bio’s internal procedures. Responsibilities: · Develops, interprets, and implements quality control policies and procedures, and supports regulatory compliance inspections. · Work within Quality team and interface with key stake-holders to maintain regulatory-compliant quality control operations. · Work with clients and internal AD group for testing methods transfer and set product specifications. · Work with clients and internal staff to ensure all QC tests remain in a compliant state, and final product meets all required standards and specifications. · Manage the environmental monitoring program to ensure the manufacturing facility is in compliance of regulatory requirement. · Ensuring data integrity compliance with the current Regulatory Guidance for all QC Quality Systems in Quality Control Operations. · Proficient in industry standard operations for analytical method qualifications based on phase-appreciate cGMP guidelines. · Work with Analytical group and ensure the smooth internal transfer of analytical methods and is responsible for continuous improvement to address outdated software, equipment, and methodology. · Work with regulatory group to author and review relevant sections of an IND application and provide technical responses. Required Experience and Skills: · Bachelor’s degree in life science discipline. · Over 10 years of relevant experience in biological drug product development, analytical chemistry and/or quality control in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required. · Subject matter expert in QC testing and lab management, including LIMS and ELN systems. · Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail. · Good communication skills to interact with clients.

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https://recruiting.paylocity.com/Recruiting/Jobs/Apply/1108994