Bob McCarrick

• Technical lead for Upstream Development and GLP Production for CHO and E. coli based expression and harvest of recombinant proteins. We use Disposable, glass and stainless steel vessels. One of my responsibilities is bringing all required equipment up to working condition followed by engineering runs prior to Project Initiation. Communicate with and bring required technicians and vendors in as required.
  Mentor and supervisor of junior scientists and engineers.
  Key member of a highly functioning upstream group which emphasizes communication, transparency and cohesiveness in our approach to work responsibilities.
  Company Safety Officer. My goal is to prevent injury and I ensure safe and effective working conditions.Technical lead for Upstream Development and GLP Production for CHO and E. coli based expression and harvest of recombinant proteins. We use Disposable, glass and stainless steel vessels. One of my responsibilities is bringing all required equipment up to working condition followed by engineering runs prior to Project Initiation. Communicate with and bring required technicians and vendors in as required. Mentor and supervisor of junior scientists and engineers. Key member of a highly functioning upstream group which emphasizes communication, transparency and cohesiveness in our approach to work responsibilities. Company Safety Officer. My goal is to prevent injury and I ensure safe and effective working conditions.…see more
• Skills: Perform scale-up studies. · Protein Expression in E. coli and CHO cells in fermenters/bioreactors. · Mentor and supervisor of support scientists and engineers. · Equipment procurement and overseeing and directing successful implementation in processes.

I worked in GMP manufacturing on two projects. E. coli expression of a COVID Antigen for clinical trials as a vaccine. The second project was the GMP production of a monoclonal antibody for COVID therapy.
Equipment included 500L SUBS and a 300L SUB for bacterial fermentation. I had the opportunity to contribute to the start up and use of Repligens' Kros Flow TFF unit. Also we under both manufacturing and development teams initiated cell clarification, chemical cell lysis, inactivation and depth filtration prior to vaccine purification

Ran fermentations of E. coli, having different constructs, and optimized fermentation control set points and media conditions to maximize recovery of soluble proteins for use as vaccines.
Performed studies of fermentation scale-up and associated downstream recoveries.

Perform installation, operational and performance qualification protocols for 4°C lab and manufacturing refrigerators and -80°C ultra low freezers. Use a Kaye Validator and Vertiteq Dataloggers to temperature map equipment

Assisted carpenter/builder in interior residential renovation. Also I worked in landscaping and I drove for UBER and LYFT. I continued to read about bioreactor based cell culture during this time.

Our group ran month long Nitrosomonas eutropha bacteria fermentations in perfusion mode. The intact whole bacterium is in human trials as a treatment for pathological skin conditions.
Expressed recombinant proteins in methylotrophic yeast cells using a 100L Sartorius fermenter
Trained high school and college interns on recombinant protein expression techniques and application in fermenters.

Responsible for conversion of a bacterial fermentation lab to a mammalian cell culture lab;
Converted 3 and 15 L bacterial fermenters to cell culture bioreactors. Recommended equipment to purchase for cell culture. Wrote development BPRs and SOPs for our new processes.
Trained a technician on cell culture procedures and related biology and equipment application in lab scale bioreactors
Bioreactor Preparation, monitoring, harvesting and clarification; run data analysis
Helped develop bioreactor processes with glass and disposable bioreactors at the PD level and part of team which transferred processes to GMP manufacturing. Communicated with PD Director Concerns and suggestions to help improve and troubleshoot on-going or potential manufacturing problems; dissolved oxygen control, high pCO2 pressures, high ammonia concentrations, foaming and shearing effects upon cells in the GMP production reactor; post translational concerns addressed at both the development and manufacturing scale
Analyzed data and reports, Screened clones and cell lines for upcoming projects

Trained other technicians/scientists in bioreactor use. Supervisor of one associate.
Media Optimization, technology transfer studies, protein expression experiments,. Our group ran satellite cultures in development reactors; 3 L media removed from 3000 L GMP reactors following inoculation put into a pd reactor and run with same conditions as GMP reactor.
Maintained, operated and troubleshot twelve bioreactors and associated process equipment. Contact and hands-on person for installation and start-up of 8 x 1 L DASGIP reactors and their control systems.
Worked with technical rep. to optimize DO and pH control, by changing PID controls, of our largest PD reactor which simulated the Manufacturing reactors.
Optimized monoclonal antibody expression in CHO and hybridoma cells for AppTec's clients.
Wrote technical reports and performed data analysis

Conducted Pichia pastoris and E. coli recombinant protein expression and recovery in 15L and 800L fermenters.
Studied effects of methanol feeding upon P. pastoris cell growth and protein expression.
Performed large scale continuous centrifugation and terminal filtration; cleaned, maintained, set-up and steam sterilized bioprocess equipment. Prepared media and buffers for fermentations.

Initiated development of fed batch and perfusion cell culture processes using spin filters in 5 L Braun bioreactors.
Trained and supervised two reports in bioreactor operation and downstream viral expression and recovery.
Performed mixing studies of micro carriers in bioreactors using different impellers and investigated various cell to micro carrier detachment and subsequent reattachment protocols.
Purified virus using terminal and tangential flow filtration systems.

Smallpox vaccine campaign for the U.S. Government; with a team member developed a serum free process for MRC-1 attachment dependent cells to serve as host cells for vaccinia production. Goal was to seed a production reactor from a seed reactor; at 5-10 fold volume increase. In the PD lab cells were seeded onto micro carriers in a 3 L bioreactor. After 5-7 days the cells were detached from the micro carriers and then reattached onto micro carriers in the 15L reactor, using trypsin and subsequent trypsin inhibitor. This process simulated a GMP production run where a 50 L seed reactor would be used to seed a 500 L production vessel. Virus was added to the reactor at ~80% cell confluence on Cytodex-1 beads; harvest occurred when the cell confluence had been reduced to ~ 20% This process was successful in the PD bioreactors; we were developing the process at the 50 and 500L level however due to concerns about a possible terrorist act using smallpox following 911 the more robust Vero cells were used to grow the vaccinia. I was in the team that went to Baxter in Austria to learn the process using Vero Cells as the host cell for vaccinia production.
Developed bioreactor perfusion systems for Vaccinia, Japanese Encephalitis and West Nile attenuated virus.

Ran fermentations of E. coli, having different constructs, and optimized fermentation control set points and media conditions to maximize recovery of soluble proteins for use as vaccines.
Performed studies of fermentation scale-up and associated downstream recoveries.

Grew and harvested bacteria grown to provide target proteins for Vertex’s small molecule programs.
Cleaned, maintained and operated two 15L bacterial fermenters, a cell homogenizer, and a continuous centrifuge.
Performed SDS-PAGE and western blots. Some small scale purification. ELISAs.

Produced and purified clinical grade gamma and beta Interferons and Hepatitis B Core Antigen.
Performed Ion exchange, size exclusion, hydrophobic and affinity chromatography.
Small and large-scale bacterial fermentation and mammalian cell culture, equipment and process validation, batch production record and SOP writing.
Team member for start-up, validation and 1st beta-interferon GMP Campaign using new bioreactors,columns and diafiltration units.

Fractionated spider venom using a HPLC; extracts were tested for glutamate inhibitory effects for potential clinical use in hypoxia.

Produced recombinant Protein A in a 500 L fermenter.
Performed large scale protein purification.
Prepared medium and buffers, cleaned equipment and glassware.