FUJIFILM Biotechnologies
Manufacturing Supervisor, Upstream
FUJIFILM Biotechnologies, College Station, Texas, United States, 77840
Overview
Manufacturing Supervisor, Upstream at FUJIFILM Biotechnologies. The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations. This individual will supervise a team of employees directly or indirectly in these production process units. Our state-of-the-art biomanufacturing facility is located in College Station, Texas. FUJIFILM Biotechnologies is part of a global organization focused on developing vaccines, cell and gene therapies, and meaningful solutions in collaboration with industry leaders. We offer a flexible work environment and a culture that aims to fuel your passion, energy, and drive — what we call Genki. Job Description
Operational oversight of systems dependent upon assignment: Upstream Unit — Single-Use Cell Culture Vessels/Bioreactors up to 2000L; Bacterial Fermentation Culture Vessels up to 2000L; Alpha Wasserman Continuous Flow Centrifuges; Disposable Magnetic Mixing Bags and Totes; Cell Expansion and Propagation; Banking/Cryopreservation of Cell Lines and Viruses; Hyperstack, Cellstack and other adherent cell technologies; Plate counting, microscopic examination; Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation Downstream Unit — Medium to Large-scale filtration systems (TFF/HFTFF, Nanofiltration, depth filtration); Medium to Large-scale Chromatographic systems (ÄKTA); Pre-Packed Columns from 1L to 100L; Single-use mixing systems (Pall & GE); Single Use connectivity types (GE DAC and Colder AseptiQuik); Plate counting, microscopic examination; Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation; Bulk filling; Aseptic process simulation and drug product filling Solution Preparation Unit — Preparation of medium and buffers from stock raw materials (compounding, mixing, testing and filtration); Weighing of raw materials per batch records with appropriate expiry; Integrity testing of filters Essential Functions
Supervise daily manufacturing activities and staff, including hiring, performance evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc. Implement project safety and quality assurance programs Execute SAP functionality for batch close out and generate SAP reports Develop, write, and review Standard Operating Procedures, Buffer Formulation Records and Batch Production Records (BPRs) Ensure proper documentation and execution of BPRs and activity records, according to cGMP regulations Lead deviation resolution and closure with subject matter expert and quality teams Track CAPAs to closure Provide input and support to R&D during development and scale up activities Represent the organization in client meetings as subject matter expert for assigned manufacturing processes Ensure adequate supply of materials; procure all materials for project prior to production Maintain confidentiality of proprietary information Drive continuous improvement in areas of responsibility Maintain effective working relationships with others Perform all other duties as assigned Required Skills & Abilities
Demonstrated leadership, coaching and mentoring skills Experience training others to perform and maintain cGMP standards Excellent skills with Microsoft Office Flexible work hours; willing to work outside of normal hours as necessary Ability to work alternative shift hours and weekends as required Strong self-discipline and attention to detail Advanced math and computer skills Strong planning and organizational skills; excellent oral and written communication; proactive in process interfacing with colleagues Ability to work with teams and collaborate effectively Excellent problem-solving skills Working Conditions & Physical Requirements
The physical demands described here are representative of those required to perform the essential functions. Reasonable accommodations may be made for individuals with disabilities. Prolonged standing, bending, pushing/pulling, reaching above shoulder, stooping, and stretching Hand-eye coordination and manual dexterity to operate office equipment Potential exposure to hazardous chemicals, gases, fumes, odors, mists, dusts Personal protective equipment: safety glasses, lab coat, safety shoes, gloves Ability to lift/pull/push up to 25 pounds frequently and up to 50 pounds on occasion Attendance is mandatory Minimum Qualifications
Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with three (3) years of relevant experience; OR Undergraduate degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with five (5) years of relevant experience; OR Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with seven (7) years of relevant experience; OR High School/GED with nine (9) years of relevant experience A minimum of two (2) years of formal or informal leadership experience A minimum of three (3) years of experience in a GMP environment Preferred Qualifications
Biotechnology Certificate Green-Belt Certification Experience with mammalian, insect, yeast, or bacterial cell lines and their cultivation and/or purification of biologics or viral vectors EEO & ADA Information
FUJIFILM is committed to equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc. If you require reasonable accommodation, please contact our HR Department at FDBTHR@fujifilm.com or (979) 431-3500.
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Manufacturing Supervisor, Upstream at FUJIFILM Biotechnologies. The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations. This individual will supervise a team of employees directly or indirectly in these production process units. Our state-of-the-art biomanufacturing facility is located in College Station, Texas. FUJIFILM Biotechnologies is part of a global organization focused on developing vaccines, cell and gene therapies, and meaningful solutions in collaboration with industry leaders. We offer a flexible work environment and a culture that aims to fuel your passion, energy, and drive — what we call Genki. Job Description
Operational oversight of systems dependent upon assignment: Upstream Unit — Single-Use Cell Culture Vessels/Bioreactors up to 2000L; Bacterial Fermentation Culture Vessels up to 2000L; Alpha Wasserman Continuous Flow Centrifuges; Disposable Magnetic Mixing Bags and Totes; Cell Expansion and Propagation; Banking/Cryopreservation of Cell Lines and Viruses; Hyperstack, Cellstack and other adherent cell technologies; Plate counting, microscopic examination; Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation Downstream Unit — Medium to Large-scale filtration systems (TFF/HFTFF, Nanofiltration, depth filtration); Medium to Large-scale Chromatographic systems (ÄKTA); Pre-Packed Columns from 1L to 100L; Single-use mixing systems (Pall & GE); Single Use connectivity types (GE DAC and Colder AseptiQuik); Plate counting, microscopic examination; Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation; Bulk filling; Aseptic process simulation and drug product filling Solution Preparation Unit — Preparation of medium and buffers from stock raw materials (compounding, mixing, testing and filtration); Weighing of raw materials per batch records with appropriate expiry; Integrity testing of filters Essential Functions
Supervise daily manufacturing activities and staff, including hiring, performance evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc. Implement project safety and quality assurance programs Execute SAP functionality for batch close out and generate SAP reports Develop, write, and review Standard Operating Procedures, Buffer Formulation Records and Batch Production Records (BPRs) Ensure proper documentation and execution of BPRs and activity records, according to cGMP regulations Lead deviation resolution and closure with subject matter expert and quality teams Track CAPAs to closure Provide input and support to R&D during development and scale up activities Represent the organization in client meetings as subject matter expert for assigned manufacturing processes Ensure adequate supply of materials; procure all materials for project prior to production Maintain confidentiality of proprietary information Drive continuous improvement in areas of responsibility Maintain effective working relationships with others Perform all other duties as assigned Required Skills & Abilities
Demonstrated leadership, coaching and mentoring skills Experience training others to perform and maintain cGMP standards Excellent skills with Microsoft Office Flexible work hours; willing to work outside of normal hours as necessary Ability to work alternative shift hours and weekends as required Strong self-discipline and attention to detail Advanced math and computer skills Strong planning and organizational skills; excellent oral and written communication; proactive in process interfacing with colleagues Ability to work with teams and collaborate effectively Excellent problem-solving skills Working Conditions & Physical Requirements
The physical demands described here are representative of those required to perform the essential functions. Reasonable accommodations may be made for individuals with disabilities. Prolonged standing, bending, pushing/pulling, reaching above shoulder, stooping, and stretching Hand-eye coordination and manual dexterity to operate office equipment Potential exposure to hazardous chemicals, gases, fumes, odors, mists, dusts Personal protective equipment: safety glasses, lab coat, safety shoes, gloves Ability to lift/pull/push up to 25 pounds frequently and up to 50 pounds on occasion Attendance is mandatory Minimum Qualifications
Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with three (3) years of relevant experience; OR Undergraduate degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with five (5) years of relevant experience; OR Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with seven (7) years of relevant experience; OR High School/GED with nine (9) years of relevant experience A minimum of two (2) years of formal or informal leadership experience A minimum of three (3) years of experience in a GMP environment Preferred Qualifications
Biotechnology Certificate Green-Belt Certification Experience with mammalian, insect, yeast, or bacterial cell lines and their cultivation and/or purification of biologics or viral vectors EEO & ADA Information
FUJIFILM is committed to equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc. If you require reasonable accommodation, please contact our HR Department at FDBTHR@fujifilm.com or (979) 431-3500.
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