BioPhase

Lead and manage clinical quality oversight, audit programs, inspection readiness, and regulatory compliance for clinical and preclinical QA. | 8+ years in GCP-regulated biotech/pharma with strong FDA, ICH, and GCP knowledge, leadership experience, and clinical QA audit expertise. | • Associate Director, Clinical, Pre-Clinical & Diagnostic QA • Remote or Hybrid in Los Angeles, CA • Must have 7+ years of GCP sponsorship auditing The Associate Director will lead quality oversight for the clinical, pre-clinical, and diagnostic programs, ensuring compliance with IBRX SOPs, ICH-GCP, FDA, EMA, MHRA, SAHPRA, and other global regulations. This role manages clinical quality strategies, audit programs, and inspection readiness while supporting cross-functional teams and developing the QMS for Clinical and Preclinical QA. Key Responsibilities • Develop and manage a risk-based GCP audit program and compliance strategy for IBRX studies. • Oversee inspection readiness and support global regulatory inspections (FDA, EMA, MHRA, PMDA, Health Canada). • Lead, mentor, and train Development QA staff, including hiring and auditor development. • Conduct audits, manage quality risks, and drive continuous improvement initiatives. • Investigate and resolve non-conformances, ensuring timely CAPA implementation. • Monitor and report compliance metrics and KPIs to identify trends and risks. • Act as SME on GCP compliance, supporting Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. • Develop and maintain SOPs, QMS processes, and supplier audit programs. Qualifications • Bachelor’s degree in life sciences or engineering with 8+ years in GCP-regulated biotech/pharma; Master’s with 6+ years acceptable. • Strong expertise in FDA, ICH, and GCP regulations; experience with early-phase trials required, late-phase preferred. • Proven success leading inspection readiness and regulatory hosting activities. • Experience hiring, training, and managing cross-functional QA teams. • ASQ Certified Quality Auditor (CQA) preferred. • Deep knowledge of GCP, clinical QA, and regulatory requirements. • Strong leadership, auditing, and risk management skills.

Execute mammalian cell culture and protein purification processes to support therapeutic protein discovery and development. | B.S. or M.S. in Biochemistry or related field with 3+ years hands-on lab experience in mammalian cell culture and protein purification. | We are seeking a highly motivated Research Associate or Senior Research Associate to join our Protein Expression and Purification team. The successful candidate will play a key role in the hands-on execution of expression and purification processes for our therapeutic proteins. This position is integral to supporting our discovery program and advancing therapeutic leads to clinical development. You will be working in a cross-functional, fast-paced team environment where your contributions will directly impact our scientific goals. Primary Responsibilities: • Conduct mammalian cell culture operations, including cell line maintenance, seed train expansion, plasmid transfections, and bioreactor operations (shake flasks). DNA production experience is a plus. • Assist with protein purifications via AKTA FPLC systems using various column chromatography techniques. • Run routine protein analysis and characterization using methods such as SDS-PAGE, Western blotting, SEC-HPLC, UV/Vis spectrophotometry, and protein quantification assays (Bradford/BCA). • Assist with laboratory operations, including preparing buffers & reagents, maintaining & ordering lab supplies, and ensuring the organization and cleanliness of common lab areas. • Maintain accurate records of purified samples through inventory management systems, protein aliquoting, protein requests, and proper storage. Qualifications: • B.S. or M.S. in Biochemistry, Molecular Biology, or a related life sciences discipline with 3+ years of relevant hands-on laboratory experience in mammalian cell culture processes for protein production and protein purification. The title will be commensurate with experience. • Well-organized with excellent time management skills and the ability to execute multiple activities in parallel. • Excellent written and verbal communication skills.