Jeff has 30+ years of experience in the pharmaceutical industry with a strong focus on downstream processing aspects for recombinant human therapeutics. His experience in Process Development has spanned from bench development, characterization, optimization, and scale up to new product introduction into clinical and commercial manufacturing spaces.

 

Technology Transfer: Jeff has led and coordinated technology transfers for production processes from Process Development bench and pilot scale to clinical production as well as from clinical to commercial and commercial to commercial across facilities at the same site as well as between sites continentally and internationally, within company as well as contract manufacturing organizations.

 

With a focus on downstream processing, Jeff has optimized harvest operations with tubular bowl and disk stack centrifuges, depth filtration operations with charged filter media, and chromatographic capture and separation processes with Ligand Affinity, Cation, Anion, as well as Hydrophobic Interaction modes. Polishing steps have included Tangential Flow Filtration and final aseptic filtration.

 

Documentation for all the above work has included the writing of standard operating procedures, manufacturing procedures, training manuals, and recipes for automation (DeltaV, Rockwell) based on process definitions as well as accompanying sample plans, equipment lists and bill of materials. He has also written and supervised process and unit operation commissioning, qualification, and validation.

 

Jeff has composed process details included in Chemistry, Manufacturing, and Controls (CMC) sections for Investigational New Drug (IND) and Biological License Application (BLA) filings for Federal Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA) and participated in pre-approval, annual and biennial facility inspections for commercial products.

 

Regarding facility design, construction, and startup, Jeff has consistently applied his knowledge and skills to renovate and remodel existing facilities: improvements to a clinical manufacturing facility to enable commercial production and licensure, and a pilot plant to enable phase appropriate manufacturing of investigative products. He has contributed as a process subject matter expert to the construction of green field facilities for process development, clinical, and commercial manufacturing with traditional design (i.e., stainless steel) as well as single use systems. He completed projects to design, fabricate, install, commission, and qualify single use systems for downstream processing unit operations, including closed and continuous processes.

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