Syracuse University

Process Validation/Technology Transfer professional

Thermo Fisher Scientific

Manager MST, Process Validation

Brammer Bio

Senior Manufacturing Manager

Sanofi Genzyme

MSAT Lead

Process engineer 2

ImmunoGen, Inc.

Senior Research Associate

Developed small scale purification processes using Affinity and Ion Exchange chromatography
Performed plate based high through-put purification using Protein A resin of cell culture from Per.C6 Mammalian cell line
Performed clarification studies from Per.C6 Mammalian cell culture utilizing Depth Filters, Hollow Fiber TFF Membranes, and Centrifugation
Used small scale/batch chromatography to generate material for Anylitical characterization of molecules

Percivia

Associate Scientist 2

Developed small scale purification processes using HIC (Hydrophobic Interaction Chromatography) and Ion Exchange chromatography
Scaled up small scale purification processes to 1.5L column scale
Planned and executed DOE process characterization/Range finding experiments for purification column steps
Developed Agarose based affinity resins using various ligand immobilization strategies
Developed, Characterized, and Scaled up manufacturing of an Agarose based affinity resin to 3L scale
Evaluated agarose based resins by Static and Dynamic Binding Capacity, Base Stability and Protease Stability
Responsible for repair and maintenance of AKTA process systems, HP 1090 HPLC systems, and Aglient 1100 series HPLC systems
Tested disposable column technology for packing quality and ruggedness
Responsible for the activities and training of COOPs

Repligen Corporation

Developed DOE applications to be used in planning product development testing including the training of other scientists
Utilized and provided input into DOPs (Development Operating Procedures) to execute development and diagnostic processes
Acted as a lead on the pack up, move, and deployment of 2 purification labs and a warehouse facility
Acted as a lead on the tech transfer of a purification/characterization project to a new facility including the relocation of the equipment and supplies as well as the analysis of data to ascertain Critical Process Parameters through statistical analysis.  Wrote the required client report and trained  new personnel in the performance of the unit operations  
Performed as Lab Lead on a column Response Surface Method range finding study consisting of a with 9 person team which included 2 large scale runs and 24 small column runs. Also involved with the design of the experiment, development of targeted objectives, process and parameters required to validate the study.
Assisted GMP Manufacturing with running of large scale purification process and troubleshooting of the process.
Helped lead the tech transfer of a mid scale process from Research and Development to GMP manufacturing suite including drafting of GMP documentation, resolving any technical issues that arise, and training of personnel in the process and safety concerns with the completion of the RAMS study plus assisting with the FMEA risk analysis of R&D project.

Lonza

Research and Development Associate 2

Familiar with the selection and operational aspects of filtration techniques in protein purification (TFF, UF, DF and Normal Flow filtration)
Experienced in the use of various Chromatography techniques in protein purification (HIC, Affinity, Ion exchange, and Cation Exchange)
Acquired working knowledge of Protein refolding techniques
Responsible for the activities and training of 2 temporary workers
Preformed scale up operation for TFF unit operations including Refold tank requirements
Led a group of 4 FTEs performing confirmation runs  on an advanced developmental compound

Research Associate 1

Todd Miller