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Dynamic professional career as a Research, Process Development, Assay Development and Technology Transfer Scientist in the biotech field and at Johns Hopkins University, and a Drug Application CMC Reviewer/Inspector at the FDA. Fifteen years in downstream purification, assay development and technology transfer in both cGLP and cGMP environments. Successful in the development and scale-up of a live oncolytic virus and protein drug products, including product characterization and assay development. Technology transfer liaison among R&D, manufacturing, facility, quality control and quality assurance groups during several phase I/II clinical studies. Through my work in new technology development (including disposable technology) and transfer, I helped create a cGMP purification chain for a live virus drug parenteral product. During this time I enjoyed being engaged in collaborations and contributing to the success of the projects and people. One of the most satisfying components in my professional experience has been contributing to a group that successfully meets their goals and deadlines for supporting a drug product candidate. Succeeding with technology transfer has allowed me to enjoy the success of others who use the new technology to produce better and safer products. My experience has help develop that the skill of effective communication is second to none for success. Qualifications in team leadership and training, strategic resource and project planning management, technical documentation and writing. Knowledge of cGLP, cGMP, FDA, EMA and OSHA regulatory requirements. Effective manager with strong interpersonal and communication skills, highly organized with an appreciation for quality and detail. Extensive qualifications in R&D and product development functions for process streamlining, improvements and cost savings for:Downstream Purification • Assay Development • Design of Experiments • Design Space • Technology Transfer
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Senior Biologist-Cder Opq Opma Division Of Biotechnology ManufacturingFdaWestminster, Md, Us -
Principal ConsultantRoan Mountain Biologics Consulting, Llc Aug 2024 - PresentProviding guidance, support, and advise for U.S. F.D.A. Biologic License Applications CMS Microbiology and Facility/Equipment submissions, preparatory and onsite support for U.S. F.D.A. pre-license and pre-approval inspections, and support for inspection compliance response in support of post inspection action.
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Senior Biologist-Cder Opq Opma Division Of Biotechnology ManufacturingFda Jul 2022 - Aug 2024Silver Spring, Md, UsFacilty, Equipment, and Microbiological CMC review of BLA applications and supplements, include lead for manufacturing facility regulatory inspections.
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Interdisciplinary Scientist - Biologist, Cder/Opq/Opma/Division Of Biotechnology ManufacturingFda Feb 2014 - Jul 2022Silver Spring, Md, UsFacilty, Equipment, and Microbiological CMC review of BLA, NDA, and ANDA applications and supplements, include manufacturing facility regulatory inspections.
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Purification ScientistWellstat Diagnostics Corp. Oct 2013 - Feb 2014Purification development and GMP production of monoclonal antibodies and proteins as clinical assay components in support of a novel medical device. -
Process Development And Technology Transfer ManagerWellstat Biologics Corporation Apr 2004 - Feb 2013As a Process Development and Technology Transfer Manager I developed orthogonal purification methods and product analytical methods for an oncolytic virus in phase I/II clinical studies, as well as transferring the purification/analytical method technology to our cGMP Manufacturing and Quality Control groups. My position was responsible for support of the Diagnostic and Therapeutic Development products. I was a lead scientist for the purification of antibodies, proteins, vectors and virus to be used in preclinical and cGMP studies. Additionally, I was also involved in developing analytical methods and assay for the characterization and release of products that were purified for the Diagnostic and Therapeutic Divisions.• Created purification processes, developed characterization assays and manufactured cGMP antibodies and proteins. • Developed the design space for the purification processes and process equipments through multi-factorial optimization studies (DoE).• Established and executed validation study protocols for scaling, protein, dsDNA, endotoxin, adventitious virus and bioburden reduction in support of a virus purification process.• Elaborated and executed process and equipment cleaning/sanitization strategies (e.g. tangential flow filtration filter reuse). • Designed and conducted study protocols to support the validation of the manufacturing purification processes (e.g. column lifetime study).• Generated technology transfer packages for product purification and analysis that included manufacturing and QC personnel training.• Wrote SOP's, Batch Records, R&D Reports and IQ/OQ/PQ documents.
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Process Development Associate IvWellstat Biologics Corporation Mar 2000 - Apr 2004• Established and scaled purification processes to address protein, dsDNA and adventitious virus removal, and bioburden reduction, for a live oncolytic virus parenteral in clinical studies (phase I/II). • Developed and scaled, manual to automated, chromatography processes from 0.5 mL up through 35 liter bed volumes, for size exclusion, adsorption and affinity chromatography (resins and membranes), for cGMP processes, with process product recovery improvements of 40% to 90%.• Developed and scaled, manual through semi-automated tangential flow filtration processes (microfiltration and ultrafiltration), from 25 cm2 to 6.0 m2 membrane area capacities, and transferred into cGMP environments, with process product recovery improvements of 40% to 90%.• Designed protein specific ELISAs to address product impurities throughout purification processes.• Characterized the purification process for product and impurities (protein and dsDNA assays, glycan differentiation analysis, electrophoresis, immunoblotting and silver stain, ELISA, fluorometry, turbidimetric analysis, spectophotometry and laser particle size analysis studies).• Critically involved with equipment and systems design, FAT, commissioning and validation for automation and scale-up of the manufacturing purification process (equipment value $1.2 million dollars).• Wrote SOP's, Batch Records, R&D Reports, IQ/OQ and contributions to CMC documents.
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Research Associate IiWellstat Biologics Corporation Mar 1998 - Mar 2000• Responsible for process purification improvements that led to increased product sterile filtration recovery, 90 to 100%.• Improved product storage and stability conditions through process and excipient changes (50% increase). • Developed alternative tangential flow filtration purification strategy that decreased processing time by 70%, reduced raw material costs significantly and increased product recovery.• Designed and characterized size exclusion column packing processes for a 100X scale up used in a live oncolytic virus purification process.
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Senior Research Assistant Ii, Sch. Of Med., Dept.Of Cell Biology & AnatomyJohns Hopkins University Nov 1993 - Mar 1998Baltimore, Md, Us• Performed and analyzed the data collected from the microinjection of the WIF-B's bile canaliculi to describe a new sub-apical sorting compartment in hepatocytes published in the Journal of Cell Biology (1998, vol.141).• Conducted study on the role of integrants ' cell-cell adhesion and intracellular signaling in human mammary epithelial cells for a NIH funded Breast Cancer project.• Established and presented (ASCB, 1996) a novel microinjection technique to detect delivery and recycling of vesicles, and their cargo, at the apical membrane of WIF-B cells.• Developed a novel semi-intact live cell system to study polarized vesicular trafficking in the hepatocyte cell line, WIF-B. Demonstrated that basolateral to apical transcytosis in a hepatic cell line is both ATP and cytosol dependent, which was presented at the ASCB meeting (1995).• Co-authored abstract presented at the 1994 Hepatology meeting that demonstrated that the hepatic organic anion transporter is present in WIF-B cells and that its function of is similar to in vivo.• Awarded the cover photo in the Journal of Cell Science (1994, vol. 107) and was first author in this publication. This publication described the development of the first highly polarized hepatocyte cell line, the WIF-B cells, and analyzed their morphology, karyotype and growth characteristics.• Awarded the cover photo in the Journal of Cell Biology (1993, vol. 123). Co-authored the publication, which described the immunological, biochemical and structural dynamic characterization of a new hepatoma cell line, the WIF-B cells. -
Senior Research Assistant I, Sch. Of Med., Dept. Of Cell Biology & AnatomyJohns Hopkins University Feb 1991 - Nov 1993Baltimore, Md, Us• Performed real time video imaging of vesicular transcytosis for 5 'nucleotidase, polymeric plgA-receptor, Endolyn-78, aminopedtidase N and alfa-2 macroglobin in the WIF-B cells.• Developed hybridomas and monoclonal antibodies for the study of polarized vesicle trafficking and sorting in epithelial cells. Characterized mRNA in polarized and non polarized hepatoma cell lines through the transfection of the WIF-B and Fao cell lines via electroporation.• Co-inventor of the first highly polarized hepatocyte cell line, the WIF-B cells. Performed the karyology, morphological and growth characteristics for the WIF-B cells, and presented at the ASCB meeting (1992).• Managed the tissue culture facility of the laboratory, a NIH Program Project tissue culture core facility and the WIF-B cell line international distribution and management center. Management of core included technicians (2) and post-docs (3) in regard to projects, use-time and training.
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Research Associate, Sch.Of Med., Dept. Of DermatologyJohns Hopkins University 1986 - 1993Baltimore, Md, Us
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Sample CustodianEtc Corp - Envirionmental Testing And Certification, Inc. Dec 1985 - Sep 1986Sample Custodian, in charge of all samples received for analyses, tracking throughout all the laboratories and final disposal of samples through sub contracted disposal company.
Mike Shanks Skills
Mike Shanks Education Details
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The Johns Hopkins UniversityGeneral -
Stockton UniversityGeneral
Frequently Asked Questions about Mike Shanks
What company does Mike Shanks work for?
Mike Shanks works for Fda
What is Mike Shanks's role at the current company?
Mike Shanks's current role is Senior Biologist-CDER OPQ OPMA Division of Biotechnology Manufacturing.
What is Mike Shanks's email address?
Mike Shanks's email address is mi****@****ail.com
What is Mike Shanks's direct phone number?
Mike Shanks's direct phone number is +130179*****
What schools did Mike Shanks attend?
Mike Shanks attended The Johns Hopkins University, Stockton University.
What are some of Mike Shanks's interests?
Mike Shanks has interest in Fishing And Hunting, Small Motor Repair, Hiking, Camping, Farming And Gardening, Electric And Plumbing, Carpentry.
What skills is Mike Shanks known for?
Mike Shanks has skills like Assay Development, Purification, Technology Transfer, Biotechnology, Gmp, Elisa, Cell, Validation, Fda, Protein Chemistry, Cell Biology, R&d.
Who are Mike Shanks's colleagues?
Mike Shanks's colleagues are Ian Carr, Phd, Anna Mielech, Felix Veras, Janae Price, Tracy Tucker, Pmp, Christine Hatfield, Robin Shaffer.
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