Vice President, Product Development @ Catalent Biologics
Chief Scientific Officer - Vice President Process Development @ Cook Pharmica
Director, Biologics Purification Development and Viral Safety @ Lilly
An experienced leader in the Biopharm and Biotech industry with over 25 years of technical and business impact spanning early and late phase process development to large-scale manufacturing. Has successfully built technical and operations teams from the ground up as well as enhancing existing teams and led them to accomplish product goals. Demonstrated stewardship efforts include facilitating
An experienced leader in the Biopharm and Biotech industry with over 25 years of technical and business impact spanning early and late phase process development to large-scale manufacturing. Has successfully built technical and operations teams from the ground up as well as enhancing existing teams and led them to accomplish product goals. Demonstrated stewardship efforts include facilitating internal multi-site harmonization of process platforms (within large pharma company), client driven projects (CMO role), and multi-company collaborations (industry consortium and conferences).
Specialties: Company lead for Quality by Design - A-Mab Case Study; Process Development for biologics including mAbs, bispecifics, glycoprotein subunit vaccines; Biosimilar Development, scale-up and and strategy; Cell culture process development, High Throughput Cell Line and Microbial Strain Screening; Protein Purification Development; Bioprocess Scale-up, Early and Late Phase Tech Transfer; Process Validation; Biotech Facility Design and Biologics Manufacturing; Formulation Development, Drug Product PPQ and Manufacturing; Lean Six Sigma Sponsor; Regulatory Submission; Project Management, Alliance Management; Large Scale Natural Product Fermentations
Chief Scientific Officer - Vice President Process Development @ The Chief Scientific Officer is responsible for serving as a member of the organization’s leadership team and drives scientific strategy for the company. As CSO, I facilitate interactions and partnering with clients toward understanding their development and manufacturing needs based on the phase of development, customer experience and capabilities, and evolving biotech processing and regulatory implications. As VP of Process Development, I lead a diverse team of scientists and engineers toward achieving cell culture, purification, analytical, and formulation goals for clients as well as driving internal capability improvements. I also lead the Project Management team which is the primary customer interface for ongoing development, DS and DP manufacturing, and packaging projects.
Cook Pharmica is an integrated contract development and manufacturing organization providing the pharmaceutical and biopharmaceutical industries with biologics drug substance and parenteral manufacturing in vials and prefilled syringes. Cook Pharmica is a privately held, wholly owned subsidiary of parent company Cook Group. From August 2012 to Present (3 years 5 months) Bloomington, Indiana AreaDirector, Biologics Purification Development and Viral Safety @ Responsibilities included managing downstream process development and viral safety activities for recombinant proteins and monoclonal antibodies in clinical and commercial development. I provided leadership for downstream process development and process technical transfer to clinical/commercial manufacturing sites and the development/implementation of viral safety strategies for mammalian cell culture derived proteins (cell bank and raw materials testing, viral clearance studies and facility protection). Significant interfaces included collaboration with discovery, upstream development, and formulation/bioanalytical efforts. I served as the Lilly lead on the QbD case study (A-Mab) multi-company consortium and led Lilly QbD development initiatives which translated strategy into process development initiatives and BLA submissions. I served as executive sponsor for multiple process core teams - assuring CMC project alignment with business, technical and clinical goals. From December 2010 to August 2012 (1 year 9 months) Indianapolis, Indiana AreaDirector, Bioprocess Operations @ Responsibilities included leading operation of the 200,000 sq ft GMP clinical trial production facility (2 X 5,000 liter capacity) which was focused on bringing new protein therapeutics to market by producing bulk API for clinical trials. I was responsible initially for facilitating C&Q efforts, staffing a new bioprocess and tech services organization and later leading operations to manufacture bulk protein API in an efficient and compliant manner. In addition, work included effectively transferring bioprocesses from development to larger-scale GMP production, optimizing processes to assure manufacturability, collaborating with commercial manufacturing on facility design, operational plans and tech transfer of late-stage processes to the commercial site. The Bioprocess staff under my supervision included technical services, process engineering, automation, operations and FUME support staff totaling approximately 80 employees. I served as the Lilly lead on the A-Mab QbD case study with 6 other industry members. From 2002 to 2010 (8 years) Indianapolis, Indiana AreaResearch Advisor - Bioprocess R&D @ Support of microbial culture high-throughput strain improvement; tech transfer of large-scale fermentation process improvements; strategy and design for microtiter screening of mammalian cell lines; coordination of cross-site development efforts with manufacturing sites; update senior leadership of animal health division for development budget and productivity enhancements. From August 1995 to July 2001 (6 years) Sr Scientist and Section Head, MS Merck Manufacturing Div @ Merck Manufacturing - MS&T (Manufacturing Science and Technical Services); Microbiology. Led strain improvement, media optimization, and fermentation process improvement efforts on commercial products (natural products); led tech transfer work from development to commercial and site to site; troubleshooting and deviation resolution. In addition, novel process approaches including enzymatic 7-ADCA production and solvent biocatalysis were developed. From October 1988 to August 1995 (6 years 11 months)
PhD, Microbiology/Molecular @ The Ohio State University Victor Vinci is skilled in: Biotechnology, Biopharmaceuticals, Technology Transfer, Process Validation, Bioprocess scale-up, Quality by Design, Biologics Manufacturing, Bioprocess Design, V&V, Manufacturing, Process Engineering, Process Simulation, Process Optimization, GMP, Six Sigma
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