Ge Jiang

About Ge Jiang

Seasoned biopharmaceutical professional with ~20 years’ experience in quality, product development and manufacturing of biologics. Proven track record in leading project CMC teams, managing product quality, compliance improvements, health authority inspections, and third party quality. Substantial CMC proficiency (accomplished 7 BLA/MAA/EUA approvals). Extensive knowledge in formulation, fill/finish, technology transfer and process validation. Skilled in project management. International experience in EU, US, and Asia. Self-motivated, creative, proactive and result-oriented in shaping strategies and driving execution.• Quality Management: Global product quality management, QA development and cGMP. Strong expertise interfacing with site QA/QC operations, R&D, manufacturing, CRO & CMOs to define quality processes. Extensive experience in specifications, similarity, comparability, stability. In depth expertise in quality systems, cGMP, external audit, managing inspections (GMP & PAI), QbD, and QRM. Sound knowledge in analytical method development, qualification, transfer & validation. • Process Development and manufacturing: Preformulation & formulation development for biologics. Process design, characterization, optimization, scale-up, technology transfer, validation and troubleshooting for DP manufacturing processes. Strong expertise in fill-finish, lyophilization, clinical & commercial manufacturing support, IQ/OQ/PQ. Comprehensive experience in validation (process, filter, cleaning, transportation, etc.). Excellent working knowledge in upstream and downstream processes, container closure systems, device and combination product development. • Regulatory CMC: Main author and/or reviewer of Module 3 for INDs, BLAs, MAAs and EUAs (e.g, Vectibix®, Prolia®, Xgeva®, Nplate®; Amjevita®, Zarxio®, pegfilgrastim biosimilar, Bamlanivimab), and briefing books. Key contributor in shaping responses for FDA and EMA questions. Experienced in preparation for Scientific Advice and Regulatory Agency meetings related to CMC.

Experience

1. Senior Director (Scientific), Technical Service Manufacturing Science

   Eli Lilly and Company

   Sep 2018 — Present · Indianapolis, IN, US

   Global molecule steward of late stage and commercial products:• Mirikizumab, a humanized IgG4 that binds IL23 for treatment of several immune diseases. Completed commercial technology transfer, process validation, global market authorization applications of OMVOH® for the ulcerative colitis indication, and managed various regulatory agency inspections and launch preparation. Lead additional tech transfers and life cycle management.• Bamlanivimab, a neutralizing mAb for SARS-CoV-2 (COVID-19): led tech transfers to internal DP sites and CMOs, prepared EUA, CMAA and responded to regulatory agencies\' questions. Project delivered at unprecedented speed – FDA EUA authorized on 11/9/20 for monotherapy, and on 2/25/21 for combination therapy with Etesevimab.• Ixekizumab (TALTZ®) life cycle management: late-stage development and process validation for the citrate-free formulation and pediatric SKUs.2. Provide technical leadership within the parenteral network, and improve interfaces between drug substance, drug product and device functional areas, e.g, assessing extractables/leachables and product compatibility for various changes of primary container components and processing materials, leading complex root cause analyses for deviations and CAPA identification, preparation of internal guidelines, white papers, etc. Functional area representative on a new facility design project for gene therapy 4. Support new modality initiatives, e.g, assessing process facility fit, equipment, analytical capability needs, evaluating new parenteral manufacturing technologies, etc.5. Mentor junior scientists and facilitate cross functional learning

Education

• University of Kentucky

  Doctor of Philosophy (PhD), Pharmaceutical Sciences

  1998 — 2002

• Pepperdine Graziadio Business School

  MBA

  2007 — 2010

Skills

• Protein Chemistry
• Purification
• Pharmaceutical Process Development
• Lyophilization
• Monoclonal Antibodies
• Formulation
• Biotechnology
• Protein Purification
• Hplc
• Cell Culture
• Pharmaceutical Industry
• Chromatography
• Validation
• Gmp
• Drug Development
• Biopharmaceuticals
• Technology Transfer