The Manufacturing Downstream Lead (Associate III-IV) is responsible for prioritizing daily schedule requirements and executing manufacturing operations within a fast-paced cGMP cleanroom environment. Serving as the main operational point of contact inside the cleanroom, this role leads core downstream processing activities-including chromatography, tangential flow filtration (TFF), filtration techniques, and product filling. The position is also instrumental in mentoring junior personnel, supporting root cause investigations and CAPAs, assisting with qualification/validation work, and ensuring cleanrooms remain organized, stocked, and audit-ready at all times.
Responsibilities:
Execute daily downstream and cleanroom manufacturing operations in compliance with cGMP standards. Perform and oversee purification techniques including Tangential Flow Filtration (TFF) and Chromatography. Execute normal flow and depth filtration, product transfers, aseptic sampling, cell expansion, and bioreactor operations. Perform manual, semi-automated, or automated product filling within aseptic environments, biological safety cabinets (BSCs), or isolators. Serve as the primary lead and operational point of contact inside the cleanroom. Coordinate product-related sample transfers and manage handovers to the Quality Control (QC) department.
Working hours: 8:00 AM - 5:00 PM
Skills:
Prior experience in a regulated cGMP biopharmaceutical or biologics manufacturing facility. Experience with Gene/Viral therapy products focusing on bioprocessing operations. Advanced knowledge of FDA and EMA regulatory requirements applicable to biologics. Familiarity with 5S methodology, lean manufacturing principles, and process optimization projects. Prior upstream processing experience (bioreactor operations, cell expansion) alongside downstream purification. Demonstrated leadership, diplomacy, collaborative teamwork, and project support capabilities.
Education:
Bachelors
Experience:
1-4 years
Qualifications:
Education & Experience: Associate or Bachelor of Science degree in Biotechnology, Biology, Chemistry, or a related discipline with a minimum of 3???4 years of manufacturing experience; OR High School Diploma (or equivalent) with a minimum of 4???5 years of relevant manufacturing experience. Technical Knowledge: Advanced understanding and practical application of cGMP principles, cleanroom operations, and aseptic practices. Advanced operational and troubleshooting expertise in downstream processing (Chromatography, TFF, filtration techniques, aseptic filling). Experience operating within biological safety cabinets (BSCs) or barrier isolators. Documentation & Investigation: Strong technical writing skills to initiate deviations, complete logbooks, and generate/update SOPs and batch documentation. Proven logic, critical thinking, and decision-making capabilities to assist with troubleshooting and root cause analysis. Physical Demands & Work Schedule Flexibility: Ability to lift up to 50 lbs. Ability to meet physical demands including standing, walking, sitting, bending, and fine motor manipulations in cleanroom attire. Comfort with spending extended periods gowning in cleanroom environments (55%???65% of the day). Flexibility to work varying schedules, including 8, 10, or 12-hour shifts across days, nights, weekends, and holidays. Willingness to travel (
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Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
key responsibilities
Execute daily downstream and cleanroom manufacturing operations in compliance with cGMP standards. Perform and oversee purification techniques including Tangential Flow Filtration (TFF) and Chromatography. Execute normal flow and depth filtration, product transfers, aseptic sampling, cell expansion, and bioreactor operations. Perform manual, semi-automated, or automated product filling within aseptic environments, biological safety cabinets (BSCs), or isolators. Serve as the primary lead and operational point of contact inside the cleanroom. Coordinate product-related sample transfers and manage handovers to the Quality Control (QC) department.
experience 1-4 years
skills Prior experience in a regulated cGMP biopharmaceutical or biologics manufacturing facility. Experience with Gene/Viral therapy products focusing on bioprocessing operations. Advanced knowledge of FDA and EMA regulatory requirements applicable to biologics. Familiarity with 5S methodology, lean manufacturing principles, and process optimization projects. Prior upstream processing experience (bioreactor operations, cell expansion) alongside downstream purification. Demonstrated leadership, diplomacy, collaborative teamwork, and project support capabilities.
qualifications
Education & Experience: Associate or Bachelor of Science degree in Biotechnology, Biology, Chemistry, or a related discipline with a minimum of 3???4 years of manufacturing experience; OR High School Diploma (or equivalent) with a minimum of 4???5 years of relevant manufacturing experience. Technical Knowledge: Advanced understanding and practical application of cGMP principles, cleanroom operations, and aseptic practices. Advanced operational and troubleshooting expertise in downstream processing (Chromatography, TFF, filtration techniques, aseptic filling). Experience operating within biological safety cabinets (BSCs) or barrier isolators. Documentation & Investigation: Strong technical writing skills to initiate deviations, complete logbooks, and generate/update SOPs and batch documentation. Proven logic, critical thinking, and decision-making capabilities to assist with troubleshooting and root cause analysis. Physical Demands & Work Schedule Flexibility: Ability to lift up to 50 lbs. Ability to meet physical demands including standing, walking, sitting, bending, and fine motor manipulations in cleanroom attire. Comfort with spending extended periods gowning in cleanroom environments (55%???65% of the day). Flexibility to work varying schedules, including 8, 10, or 12-hour shifts across days, nights, weekends, and holidays. Willingness to travel (education Bachelors