BioSpace
Sr. Associate, Manufacturing (Grave Shift)
BioSpace, Novato, California, United States, 94949
Overview
Sr. Associate, Manufacturing (Grave Shift) role at BioSpace. The Associate/Sr. Associate is responsible for working on a shift with 6 – 10 peers with responsibilities of preparing large scale solutions (buffers and media), managing raw material inventory, and operating process equipment in Upstream or Downstream areas while supporting daily operations. The position requires shift work including weekends, off hours and holidays, and compliance with cGMP, SOPs, product licenses, corporate policies, and safety practices. Responsibilities
Operate large scale bioprocess equipment for the Cell Culture, Purification, or Buffer and Media processing. Perform all aspects of processing with a broad understanding of science, compliance, and technical aspects. Demonstrate competency with process equipment and automated control systems. Perform cleaning and sterilization of parts and equipment used in the manufacturing process. Have knowledge of biotech manufacturing processes and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations. Understand, apply, and evaluate basic chemistry, biology, and scientific principles relevant to the role. Ensure compliance by adhering to SOPs, batch records, good documentation practices and data capture. Qualifications
Bachelor’s degree in a science-related field or engineering, or an associate degree in a science-related field or biotech certificate with 2+ years of experience in biotech manufacturing or other regulated industry. Experience: 2 years of industry experience. Skills: strong communication skills (verbal and written); ability to work in a team environment with good conflict resolution and collaboration; initiative to identify areas for improvement and implement solutions. Work Environment / Physical Demands
Strenuous, repetitive work. Physical movements may include bending, reaching, climbing stairs and ladders, kneeling, and making equipment connections using hands and tools. Ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. May require work around loud equipment and use of personal protective equipment. Shift-based work including off hours. Additional Details
Education/Experience: as specified above. Equipment may include autoclave, lab washer, bioreactors, automated CIP skids, welders, ultrasonic baths, stainless steel vessels and analytical benchtop equipment. Shift details: Rotating 13-hour shifts. Hours: 6:00 PM – 7:00 AM; night shift Thursday–Saturday with alternating Wednesdays. Onsite only; no travel required. Equal Opportunity Employer/Veterans/Disabled: BioMarin/ BioSpace conforms to EEO guidelines. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. Company
BioMarin’s Technical Operations group supports manufacturing and scaling production of drugs for clinical trials and commercial use, ensuring regulatory compliance and quality.
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Sr. Associate, Manufacturing (Grave Shift) role at BioSpace. The Associate/Sr. Associate is responsible for working on a shift with 6 – 10 peers with responsibilities of preparing large scale solutions (buffers and media), managing raw material inventory, and operating process equipment in Upstream or Downstream areas while supporting daily operations. The position requires shift work including weekends, off hours and holidays, and compliance with cGMP, SOPs, product licenses, corporate policies, and safety practices. Responsibilities
Operate large scale bioprocess equipment for the Cell Culture, Purification, or Buffer and Media processing. Perform all aspects of processing with a broad understanding of science, compliance, and technical aspects. Demonstrate competency with process equipment and automated control systems. Perform cleaning and sterilization of parts and equipment used in the manufacturing process. Have knowledge of biotech manufacturing processes and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations. Understand, apply, and evaluate basic chemistry, biology, and scientific principles relevant to the role. Ensure compliance by adhering to SOPs, batch records, good documentation practices and data capture. Qualifications
Bachelor’s degree in a science-related field or engineering, or an associate degree in a science-related field or biotech certificate with 2+ years of experience in biotech manufacturing or other regulated industry. Experience: 2 years of industry experience. Skills: strong communication skills (verbal and written); ability to work in a team environment with good conflict resolution and collaboration; initiative to identify areas for improvement and implement solutions. Work Environment / Physical Demands
Strenuous, repetitive work. Physical movements may include bending, reaching, climbing stairs and ladders, kneeling, and making equipment connections using hands and tools. Ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. May require work around loud equipment and use of personal protective equipment. Shift-based work including off hours. Additional Details
Education/Experience: as specified above. Equipment may include autoclave, lab washer, bioreactors, automated CIP skids, welders, ultrasonic baths, stainless steel vessels and analytical benchtop equipment. Shift details: Rotating 13-hour shifts. Hours: 6:00 PM – 7:00 AM; night shift Thursday–Saturday with alternating Wednesdays. Onsite only; no travel required. Equal Opportunity Employer/Veterans/Disabled: BioMarin/ BioSpace conforms to EEO guidelines. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. Company
BioMarin’s Technical Operations group supports manufacturing and scaling production of drugs for clinical trials and commercial use, ensuring regulatory compliance and quality.
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