Plantation, Florida, United States · On-site
Description Scope of Function: The Bioprocess Specialist position reports to the Upstream Manufacturing, Manager. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prereq…
Skills: GMP Manufacturing, Aseptic Technique, Bioreactor Operation, Cell Culture, Cell Banking
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Responsible for supporting upstream GMP processes to produce bulk biologics from microbial and cell culture systems. This includes operating pharmaceutical equipment and executing manufacturing batch records in compliance with cGMP guidelines.
Requires a BS degree in Science or Engineering, or an Associate degree/High School diploma with at least 3 years of GMP biologic production experience. Strong documentation skills and experience with aseptic techniques are essential.
Description
The Bioprocess Specialist position reports to the Upstream Manufacturing, Manager. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. This role is responsible for supporting the overall Upstream GMP process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase 1/11/111 and commercial GMP manufacturing.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
Requirements
Your CDMO Partner for On-Time Process Development and cGMP Manufacturing.
GBI, based near Fort Lauderdale, Florida, is a fully integrated, customer-focused cGMP Contract Development Manufacturing Organization (CDMO) of Biosimilar and innovative monoclonal antibodies, recombinant proteins, vaccines, Antibody Drug Conjugates (ADCs), and other bioconjugates. GBI offers a wide range of Single Source Solution services, including cell line development, GMP master cell banking, proof-of-concept development, cell culture, purification, and bioconjugation process development, scale-up, GLP pilot manufacturing for Tox animal studies, and cGMP manufacturing with fill & finish for human clinical trials. These core services are complemented by full support relative to assay development and qualification, analytical and microbiological Quality Control (QC), and Quality Assurance and Regulatory Affairs (QA/RA). With over 20 years of experience as an independent contract development and manufacturing service provider, GBI has worked with organizations of all sizes, from academic research institutions and virtual biotech start-ups to large, established multinational corporations.
Offices: 1850 NW 69th Ave, Fort Lauderdale, Florida 33313, US
Your CDMO Partner for On-Time Process Development and cGMP Manufacturing.
GBI, based near Fort Lauderdale, Florida, is a fully integrated, customer-focused cGMP Contract Development Manufacturing Organization (CDMO) of Biosimilar and innovative monoclonal antibodies, recombinant proteins, vaccines, Antibody Drug Conjugates (ADCs), and other bioconjugates. GBI offers a wide range of Single Source Solution services, including cell line development, GMP master cell banking, proof-of-concept development, cell culture, purification, and bioconjugation process development, scale-up, GLP pilot manufacturing for Tox animal studies, and cGMP manufacturing with fill & finish for human clinical trials. These core services are complemented by full support relative to assay development and qualification, analytical and microbiological Quality Control (QC), and Quality Assurance and Regulatory Affairs (QA/RA). With over 20 years of experience as an independent contract development and manufacturing service provider, GBI has worked with organizations of all sizes, from academic research institutions and virtual biotech start-ups to large, established multinational corporations.
Offices: 1850 NW 69th Ave, Fort Lauderdale, Florida 33313, US
