manufacturing associate iii - drug substance - microbial.

Responsibilities:
Manufacturing Operations Execution (60%): Independently perform microbial upstream activities according to batch records, SOPs, production schedules, and cGMP standards. Execute media/inoculum prep, cell expansion, seed train operations, fermentation, bioreactor operations, harvest, and clarification. Operate, monitor, and perform routine troubleshooting on fermenters, bioreactors, filtration systems, pumps, and process instrumentation, escalating complex issues as needed. Track process parameters, detect process abnormalities, and report equipment issues or deviations promptly. Prepare, clean, sanitize, and sterilize equipment; collect and transfer samples to Quality Control. Document all manufacturing activities contemporaneously and accurately in alignment with data integrity practices. Support downstream operations as needed (e.g., cell disruption, homogenization, filtration, and clarification) based on training and business needs.
Readiness & Compliance Maintenance (20%): Keep manufacturing suites and processing equipment clean, organized, safe, and in an inspection-ready state. Stage, reconcile, and verify process materials and supplies to support inventory management. Conduct equipment readiness checks and adhere to biosafety, contamination control, and cleanroom gowning requirements.
Training & Technical Peer Support (10%): Maintain up-to-date training qualifications across assigned equipment and processes. Deliver hands-on guidance and peer training to less-experienced associates. Share best practices and assist with routine operational troubleshooting.
Documentation & Continuous Improvement (10%): Participate in team operational meetings and cross-functional planning. Assist in deviation investigations, root-cause analyses, CAPA implementations, and process enhancement projects. Support revisions of SOPs and batch records, as well as validation and equipment qualification tasks.

Working hours: 8:00 AM - 5:00 PM

Skills:
Associate or Bachelor's degree in Microbiology, Biology, Biotechnology, Biochemistry, Chemistry, or a related scientific discipline.
Prior biomanufacturing experience specifically within a cGMP-regulated biopharmaceutical or biotechnology facility.
Experience executing downstream unit operations (e.g., homogenization, cell lysis/disruption, tangential flow filtration, depth filtration).
Familiarity with 5S methodology and Lean manufacturing principles.
Prior involvement supporting formal deviation investigations, CAPAs, and batch record or SOP authoring/revisions.

Education:
Associate

Experience:
4-7 years

Qualifications:
Education & Experience: High school diploma (or equivalent) paired with additional relevant biomanufacturing experience, OR an Associate/Bachelor's degree in a relevant technical/scientific discipline. Minimum of 3???4 years of relevant manufacturing experience. Hands-on experience with microbial fermentation, upstream bioprocessing, or microbial-based production. Demonstrated background operating bioreactors, fermenters, microbial cell expansion equipment, and upstream process systems.
Technical Knowledge & Compliance: Strong working knowledge of cGMP regulations, contemporaneous documentation practices, and data integrity standards. Working understanding of contamination control, biosafety practices, aseptic techniques, equipment sanitization/sterilization, and regulatory standards (e.g., FDA).
Execution & Communication: Proven capability to independently follow master batch records and standard operating procedures. Sound problem-solving judgment to troubleshoot routine process interruptions and identify when to escalate complex issues. Strong cross-functional communication, organization, and time management skills in a dynamic plant environment. Proficiency with basic computer systems and electronic documentation platforms.
Physical & Schedule Capabilities: Ability to work rotating shifts, including 8-, 10-, or 12-hour shifts (with potential nights, weekends, holidays, and overtime). Ability to meet physical manufacturing demands, including standing, bending, kneeling, gowning, fine motor manipulation, and lifting up to 50 lbs.


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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).