Chidi Obi
Director, Analytical and Formulation Development @Abcuro, Inc
Signup · Get unlimited contacts
WORK HISTORY
Director, Analytical and Formulation Development @Abcuro, Inc
US
Driver of analytical and formulation strategies for late phase development. • Create and manage analytical and formulation development budget.• Leads all BLA enabling analytical and formulation studies such as forced degradation, CIEX and SEC fraction collection and characterization, HCP coverage determination, formulation robustness, DS/DP method validations, pre-PPQ vs PPQ DS/DP comparability, LER, RPT, Microbial challenge and others.• Manage 30 analytical and formulation BLA enabling projects performed by 15 vendors.• Manage multiple comparability studies to support manufacturing process changes.• Manage multiple cell-based potency (ADCC, ADCP and CDC) assays method development, optimization, qualification, validation and transfer.• Generate/establish MSAs (Master Service Agreements) and SOWs with multiple vendors.• Author of Critical Quality Attributes of a phase 3 Biologic.• Develop strategies and oversee the execution of analytical activities associated with both DS and DP development and manufacturing, supporting clinical development, and regulatory filings.• Managed the successful transfer, qualification and validation of ADCC assay in 9 months.• Select, contract and manage multiple CDMOs and CTLs and suppliers including technical, quality and financial aspects of AD, QC and formulation activities.• Manage AD and formulation activities in support of process characterization, PPQ and other BLA supporting activities.• Review and approve test methods, qualification and validation protocols and reports.• AD and Formulation department representative on CMC teams.• Member of Technical Operations Leadership Team.• Foster and contributes to team culture of scientific rigor, accountability, and inclusivity through management/mentorship of internal FTEs and supporting internal development.• Communicates progress (reports and presentations) regarding AD and formulation related activities to key stake holders both internally and externally.
EDUCATION
University of Nigeria, Nsukka
B.Sc (Hons), Industrial Chemistry
San José State University
MS, Analytical Chemistry
SKILLS
ABOUT CHIDI OBI
Experienced CMC analytical leader supporting development and regulatory approval of biologics.Author, review, approve CMC sections in IND, INDa, IMPD, BLA, and ROW regulatory submissions and helped resolve regulatory agencies CMC questions. Over 25 years of CMC experience in the biotechnology/pharmaceutical industry with leadership in multiple organizations.Have led technology transfers to (and management of) CDMOs, CMOs, CROs, and CTLs in USA, Europe and Asia.Have contributed to bringing thirty biopharmaceuticals from research environment through scale up, development and introduction to the clinic, including two approved products.Successful track record in leading Analytical, Formulation development and QC groups.Successful history leading analytical verification/qualification/validation of all methods required for characterization, release, and stability of biologics.Successful oversight of late-stage formulation and analytical activities, responding to analytical deviations/investigations and proactively establishing best in class analytical procedures and practices.Track record of managing in-house and outsourced analytical development and quality control activities at CROs/CTLs/CDMOs/CMOs and leading the transition of methods from AD into QC labs from development to commercial. Led cross functional project teams through all phases of drug development and associated regulatory submissions.Experienced in conducting Analytical due diligence and vendor audits.Very strong independent self-motivated and driven leadership, communication and collaboration skills to collaborate virtually with CRO/CTL/CDMO/CMO partners.Expertise in troubleshooting analytical method development/qualification/validation/verification/transfer/comparability, and the application of statistical approaches and methodology to analyze data and make decisions.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.