Cally Zanarini
Associate Director Manufacturing Operations at BioFactura, Inc.- Claim this Profile
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Bio
Christopher Hsu, MBA, PMP
I worked with Cally in the Large Scale Downstream Purification department at Human Genome Sciences. From the moment Cally started, she proved herself to be one of the department's most dedicated and reliable associates. She frequently took the initiative to be trained on process and equipment, and as a result quickly became able to work independently and assist the team. I would say Cally's professionalism and ability to communicate is one of her most outstanding traits, and makes her extremely easy to get along and work with on a daily basis. Additionally, you can always count Cally to accomplish her assignments on time and with a high level of quality. I would definitely recommend Cally. I wish her the best!
Christopher Hsu, MBA, PMP
I worked with Cally in the Large Scale Downstream Purification department at Human Genome Sciences. From the moment Cally started, she proved herself to be one of the department's most dedicated and reliable associates. She frequently took the initiative to be trained on process and equipment, and as a result quickly became able to work independently and assist the team. I would say Cally's professionalism and ability to communicate is one of her most outstanding traits, and makes her extremely easy to get along and work with on a daily basis. Additionally, you can always count Cally to accomplish her assignments on time and with a high level of quality. I would definitely recommend Cally. I wish her the best!
Christopher Hsu, MBA, PMP
I worked with Cally in the Large Scale Downstream Purification department at Human Genome Sciences. From the moment Cally started, she proved herself to be one of the department's most dedicated and reliable associates. She frequently took the initiative to be trained on process and equipment, and as a result quickly became able to work independently and assist the team. I would say Cally's professionalism and ability to communicate is one of her most outstanding traits, and makes her extremely easy to get along and work with on a daily basis. Additionally, you can always count Cally to accomplish her assignments on time and with a high level of quality. I would definitely recommend Cally. I wish her the best!
Christopher Hsu, MBA, PMP
I worked with Cally in the Large Scale Downstream Purification department at Human Genome Sciences. From the moment Cally started, she proved herself to be one of the department's most dedicated and reliable associates. She frequently took the initiative to be trained on process and equipment, and as a result quickly became able to work independently and assist the team. I would say Cally's professionalism and ability to communicate is one of her most outstanding traits, and makes her extremely easy to get along and work with on a daily basis. Additionally, you can always count Cally to accomplish her assignments on time and with a high level of quality. I would definitely recommend Cally. I wish her the best!
Credentials
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Yellow Belt Certified
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Experience
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BioFactura, Inc.
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United States
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Biotechnology Research
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1 - 100 Employee
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Associate Director Manufacturing Operations
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Feb 2023 - Present
Manage the cell culture and purification teams working biosimilar and DOD contracts for biopharmaceuticals. Helping develop and process pre-clinical through Phase 1 antibodies.
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Manager - Downstream Manufacturing Operations
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Feb 2021 - Feb 2023
As manager of purification manufacturing at Biofactura, I support the tech transfer from PD to Phase 1 manufacturing at our local manufacturing facility. I own all downstream equipment and help keep the facility in a classified state. The manufacturing team that I lead provides pre-clinical and Phase 1 material for testing. I also work with the tech transfer process to CMOs that produce our Phase 3 and commercial material. The nature of a small facility means that I also work very closely with… Show more As manager of purification manufacturing at Biofactura, I support the tech transfer from PD to Phase 1 manufacturing at our local manufacturing facility. I own all downstream equipment and help keep the facility in a classified state. The manufacturing team that I lead provides pre-clinical and Phase 1 material for testing. I also work with the tech transfer process to CMOs that produce our Phase 3 and commercial material. The nature of a small facility means that I also work very closely with upstream tech transfer and manufacturing.
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Senior Bioprocess Engineer
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Sep 2019 - Feb 2021
Owner of manufacturing purification of monoclonal antibodies, working on multiple Phase 1 drugs for trials. Working closely to support cell culture bioreactors and Repligen ATF technology transfer and scale up. Most equipment is single use technology. Writing validation documents for upstream, downstream and utility manufacturing systems to ensure GMP compliance. Worked closely with Quality to roll out an updated documentation system with updated SOPs, WIs, and Production records.
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Utility Engineer
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Jun 2014 - Sep 2019
Work entailed the design and start up of utility systems for a newly constructed bio pharmaceutical plant. My previous role in utility engineering included project work on the utilities used to run 2 full time bio pharmaceutical manufacturing facilities. This includes boilers, chillers, water treatment systems, air handlers, and compressed gas systems. Major projects I have worked on include the implementation of setbacks on air handling systems and the install of chiller optimization systems… Show more Work entailed the design and start up of utility systems for a newly constructed bio pharmaceutical plant. My previous role in utility engineering included project work on the utilities used to run 2 full time bio pharmaceutical manufacturing facilities. This includes boilers, chillers, water treatment systems, air handlers, and compressed gas systems. Major projects I have worked on include the implementation of setbacks on air handling systems and the install of chiller optimization systems. I am the responsible person for meeting and setting site goals for water and energy reduction. I am currently working full time on procuring and installing new utility equipment for a bio pharmaceutical plant that is under construction.
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Senior Biopharm Manufacturing Associate
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Jan 2013 - Jun 2014
Work in the manufacturing of monoclonal antibodies. Perform purification processes including chromotography and diafiltration in a cGMP environment. Help determine and make process changes. Proficient in multiple IT systems, such as Trackwise, DeltaV, Unicorn, and QUMAS. Work on the development of batch records and SOPs for new processes and process changes. Extremely proficient on bulk fill processes. Subject matter expert on manufacturing spectrophotometer. Experience… Show more Work in the manufacturing of monoclonal antibodies. Perform purification processes including chromotography and diafiltration in a cGMP environment. Help determine and make process changes. Proficient in multiple IT systems, such as Trackwise, DeltaV, Unicorn, and QUMAS. Work on the development of batch records and SOPs for new processes and process changes. Extremely proficient on bulk fill processes. Subject matter expert on manufacturing spectrophotometer. Experience working on procurement of new materials with external companies. Currently working on tech transfer to large scale facility, focus on bulk fill. Investigation work for deviations
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Human Genome Sciences
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United States
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Biotechnology
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400 - 500 Employee
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Manufacturing Associate III
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Jun 2010 - Jan 2013
Worked on the manufacturing of Benlysta, a monoclonal antibody that's used in the treatment of systemic lupus. Helped reach the goal of FDA approval of Benlysta Performed processes including chromotography and diafiltration in a cGMP environment Worked on the manufacturing of Benlysta, a monoclonal antibody that's used in the treatment of systemic lupus. Helped reach the goal of FDA approval of Benlysta Performed processes including chromotography and diafiltration in a cGMP environment
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Virginia Tech
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United States
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Higher Education
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700 & Above Employee
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research assistant
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Jan 2009 - May 2010
Research on plant based polymers and experimenting with producing these in a lab setting. Research on plant based polymers and experimenting with producing these in a lab setting.
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Education
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2005 - 2010
Virginia Tech
B.S., Biological Systems Engineering -
2007 - 2008
University College Dublin
NA, Bio Engineering
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