ABL
Overview
Advanced BioScience Laboratories (ABL) has over 60 years of experience as a service provider to the life sciences industry. Founded in 1961, ABL specializes in GMP manufacturing, analytical testing, and product development, supporting candidate vaccines and therapeutics through preclinical and clinical development stages. CDMO services include manufacturing GMP cell banks and viral vectors, process development, assay development, and release testing. Purpose of Job
The GMP Specialist III is responsible for aseptic filling operations in Class A/B areas, including loading/unloading vials, stoppers, seals, and cleaning activities. This role operates general production equipment such as Automatic Fill Machine, Filter Integrity Tester, Autoclave, Analytical Scales, pH/conductivity meters, and more. Additional duties include document preparation and revision, document requests, inventory review, quality records preparation and approval, leading continuous improvement efforts, and cross-functional communication. Successful candidates will be cross-trained for Upstream and Downstream work as needed. Responsibilities
Participate in automated aseptic fill-finish cGMP manufacturing activities. Lead formulation/fill-finish tasks as required; identify issues and propose solutions. Demonstrate technical expertise in Aseptic Techniques for Formulation, Aseptic transfer/Filtration and Filling, and operate equipment such as Automatic Fill Machine, Filter Integrity Tester, Autoclave, Analytical Scales, pH/conductivity meters, and related tools. Experience with Flexicon automated fill units is a plus. Perform Level 4/Aseptic gowning and extended period of fill-finish process execution. Conduct Environmental Monitoring for Grade A/B during product fills per regulatory guidelines. Prepare equipment and tubing assembly related to the filling operation. Cross-train and participate in Upstream and Downstream operations as needed. Write/review standard operating procedures, batch records, deviations, and other technical documents related to fill-finish operations; provide support for upstream and downstream documentation as needed. Maintain a safe laboratory environment by adhering to safety policies. Comply with cGMP regulations and timely accurate completion of records. Work toward SME status and train other staff as required. Ensure processing equipment and instruments are identified and maintained per internal procedures. Communicate and suggest regular process improvements to management. Collaborate with quality assurance, quality control, manufacturing, facilities, and other support staff. Vaccination is required in support of upcoming project. Perform other duties as assigned. Qualifications
Bachelor’s degree in science or related field with a minimum of 4 years of experience in fill-finish, or Master’s degree with a minimum of 2 years of experience in fill-finish (experience may be considered in lieu of a degree). Minimum 5 years of experience in a cGMP environment. Strong interpersonal and communication skills (written and oral) with QA, QC, manufacturing, facilities, and other support staff. Task- and team-oriented, analytical, organized, detail-oriented, self-motivated, and able to multi-task. Initiative and ability to work effectively with diverse teams.
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Advanced BioScience Laboratories (ABL) has over 60 years of experience as a service provider to the life sciences industry. Founded in 1961, ABL specializes in GMP manufacturing, analytical testing, and product development, supporting candidate vaccines and therapeutics through preclinical and clinical development stages. CDMO services include manufacturing GMP cell banks and viral vectors, process development, assay development, and release testing. Purpose of Job
The GMP Specialist III is responsible for aseptic filling operations in Class A/B areas, including loading/unloading vials, stoppers, seals, and cleaning activities. This role operates general production equipment such as Automatic Fill Machine, Filter Integrity Tester, Autoclave, Analytical Scales, pH/conductivity meters, and more. Additional duties include document preparation and revision, document requests, inventory review, quality records preparation and approval, leading continuous improvement efforts, and cross-functional communication. Successful candidates will be cross-trained for Upstream and Downstream work as needed. Responsibilities
Participate in automated aseptic fill-finish cGMP manufacturing activities. Lead formulation/fill-finish tasks as required; identify issues and propose solutions. Demonstrate technical expertise in Aseptic Techniques for Formulation, Aseptic transfer/Filtration and Filling, and operate equipment such as Automatic Fill Machine, Filter Integrity Tester, Autoclave, Analytical Scales, pH/conductivity meters, and related tools. Experience with Flexicon automated fill units is a plus. Perform Level 4/Aseptic gowning and extended period of fill-finish process execution. Conduct Environmental Monitoring for Grade A/B during product fills per regulatory guidelines. Prepare equipment and tubing assembly related to the filling operation. Cross-train and participate in Upstream and Downstream operations as needed. Write/review standard operating procedures, batch records, deviations, and other technical documents related to fill-finish operations; provide support for upstream and downstream documentation as needed. Maintain a safe laboratory environment by adhering to safety policies. Comply with cGMP regulations and timely accurate completion of records. Work toward SME status and train other staff as required. Ensure processing equipment and instruments are identified and maintained per internal procedures. Communicate and suggest regular process improvements to management. Collaborate with quality assurance, quality control, manufacturing, facilities, and other support staff. Vaccination is required in support of upcoming project. Perform other duties as assigned. Qualifications
Bachelor’s degree in science or related field with a minimum of 4 years of experience in fill-finish, or Master’s degree with a minimum of 2 years of experience in fill-finish (experience may be considered in lieu of a degree). Minimum 5 years of experience in a cGMP environment. Strong interpersonal and communication skills (written and oral) with QA, QC, manufacturing, facilities, and other support staff. Task- and team-oriented, analytical, organized, detail-oriented, self-motivated, and able to multi-task. Initiative and ability to work effectively with diverse teams.
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