Joseph Phillips Email & Phone Number

Austin, Texas, Us

• Established and lead manufacturability/developability assessment process for robust lead candidate selection of molecules with high potential to advance successfully through clinical development • Lead development of bioanalytical assays to monitor PK, ADAs and neutralizing antibodies for clinical trials• Lead cell line development function to engineer proprietary production cell lines that delivers target product quality attributes of engineered toxin bodies (ETBs) at unprecedented productivity• Lead biopharmaceutical development function to deliver robust drug substance and drug product manufacturing processes, and highly discriminating analytical methods for transfer to internal and external cGMP manufacturing facilities and QC laboratories. • Lead Product Attribute Sciences to elucidate structure of engineered toxin bodies to understand product quality attributes for preclinical, clinical development and comparability assessment• Lead formulation development function to deliver novel formulations for successful drug product manufacturing, assure long-term shelf-life and successful clinical administration• Lead internal manufacturing functions, clean room production, site facilities & engineering and EH&S • Select/qualify CDMOs for strategic partnerships for cost-effective production of high-quality clinical trial materials and establish plans for commercial manufacturing• Direct external CDMO partners for drug substance and drug product manufacturing, ensuring successful tech transfer of process unit operations, analytical methods for IPCs and QC release testing• Lead QC/QA operations ensuring batch release testing, batch disposition and stability testing are executed to meet clinical trial timelines • Support clinical supply chain operations with timely delivery and maintenance of planned clinical supplies• Submit and update CMC regulatory modules, meeting phase-appropriate standards through early to late clinical development

Calabasas, Ca, Us

• Established strategic partnerships with CMOs for cost-effective production of high-quality clinical trial materials and executed plans for commercial manufacturing • Managed CDMO partners to develop drug substance and drug product manufacturing processes, and execute production of IgG-enzyme fusion protein therapeutics for Phase I/III clinical studies • Directed contract testing labs to develop and apply high quality biochemical, biological and biophysical analytical methods for process and product characterization, release and stability studies• Managed QC/QA activities for raw materials, drug substance and drug product through GMP manufacturing to final product disposition and stability• Submitted and updated CMC regulatory modules, ensured CMC regulatory requirements for biotherapeutics development phase-appropriate standards were met• Lead clinical supply chain function effectively to ensure clinical material demands were met for US and international trials without interruption

• Advisor to executives leading biologic therapeutics candidate optimization, bioprocess and product development, technical operations, quality and manufacturing operations.• Provided executive oversight for biotherapeutics portfolio reviews for lead candidate selection to advance to preclinical and clinical development. • Provided technical advice on process development unit operations, tech transfers, clinical and commercial manufacturing execution.• Provided expertise on global CMC strategy and preparation of filing submissions• Guided organizational design, KPIs, budgeting and portfolio management for pipeline advancement of biologic therapeutics and small molecule candidates. • Advisor on bioprocess development applications of on-line biosensor technologies targeted for cell culture, purification and fill/finish operations.

Thousand Oaks, Ca, Us

Administered manufacturability program to rapidly screen drug candidates to identify lead candidate. • Studied product quality attributes to understand their biological relevance, immunogenic potential and performance liabilities. • Developed mammalian and bacterial cell culture expression systems to optimize productivity, quality and production costs. • Characterized single-use manufacturing systems. • Established interchangeability of bioprocessing raw materials to optimize supply chain, inventory and cost. • Applied Content Analytics to interrogate databases to derive product insights and reduce closure time for product investigations. • Applied “in silico” drug development tools to eliminate exploratory experimentation.

Thousand Oaks, Ca, Us

Delivered phase I, II and III clinical and commercial drug product formulations. • Transferred drug product manufacturing process technologies to clinical and commercial operations. • Executed root-cause forensics investigations for clinical and commercial non-conformances, biological product deviations, customer complaints, primary container failures and device failures. • Delivered hand-held raw material identification tools and libraries and testing protocols to QC, clinical, and commercial manufacturing network. • Guided international consortium of regulatory and biopharmaceutical industry experts to define Quality by Design principles and practices for biologics product development and manufacturing.

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Ph.D., Pharmaceutics And Analytical Chemistry

Bsc., Applied Chemistry

Msc., Organometallic Chemistry