Senior Manufacturing Associate I​/II - Downstream

Senior Manufacturing Associate I/II - Downstream

Job Summary

The Sr. Manufacturing Associate I/II is responsible for the execution of upstream or downstream production activities for early and late-phase Cell Culture programs within a GMP environment.

The role requires following instructions depicted in SR’s, EPR’s,  ’s, SOP’s and forms, ensuring all work follows Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP), including ‘Right the First Time’ (RFT). Identify possible process and record improvements and communicate these to the appropriate personnel.

The ideal candidate is technically sound and has a quality mindset. The candidate will demonstrate experience in cell culture fundamentals such as media preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest, aseptic technique, chromatography, ultrafiltration, drug substance filling operations, and analytical tools. Experience with pumps, sterile tubing welders, sealers, pH/Conductivity/Osmolarity meters is also required.

The Sr. Manufacturing Associate I/II promotes and enforces precise and compliant operations, maintains a sense of ownership over the manufacturing environment, and reviews production records for accuracy. Any deviations/events must be documented and escalated to management and quality systems per internal notification processes.

• Manufacture cell culture products per batch records, ensuring compliance with quality standards, company policies, and current regulations.
• Perform operations in a cleanroom environment, including gowning, cleaning, and aseptic processing controls.
• Document every task involving manufacturing procedures (SR’s, EPR’s,  ’s) following GDP at the time of execution.
• Utilize and perform maintenance on equipment per applicable SOP.
• Ensure all items are issued and accounted for during the execution of a record.
• Demonstrate, apply and ensure understanding of current Good Manufacturing Practices.
• Participate in and be accountable for 5S activities.
• Provide direction and guidance to Manufacturing Associates I and II, and supervisors, to distribute workload and ensure task understanding.

• Education:
  
  Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ experience in GMP manufacturing for Associate I; or high school diploma with 7-10 years’ experience. For Associate II, Bachelor’s degree with 5+ years’ experience or high school diploma with 10+ years’ experience.

• Demonstrated knowledge of cell culture, fermentation, or purification unit operations.
• Experience in single-use platform technology.
• Excellent written and verbal communication skills.
• Energetic, motivated, and dynamic individual.
• Organized, able to focus in a fast‑paced, multi‑tasked environment.

• Fluent in English (reading, writing, interpreting documents, writing reports, speaking effectively).

• Ability to solve practical problems and interpret various instructions.

• Ability to perform basic arithmetic, compute rates, ratios, percentages, and interpret graphs.

• Standing and sitting for long periods.
• Lifting, pushing, pulling, and ladder use during bioreactor setup.

• Knowledge and experience using MS Office, ERP, EDMS, and production equipment software.

• Experience with biosafety cabinets, incubators, single-use bioreactors, chromatography columns, ultrafiltration skids, filling systems, peristaltic pumps, automated cell counters, analyzers, balances, and laboratory equipment.

• Work 12‑hour shifts, including overnight.
• Work within a cGMP manufacturing biotechnology facility requiring cleanroom attire and good personal hygiene.

• Annual bonus, medical, dental, and vision coverage, paid PTO and holidays, 401(k) matching, and employee recognition programs.

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) offering integrated drug development and biologics manufacturing services.

kbi is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe innovation thrives where all voices are heard and valued. We actively seek individuals from all backgrounds and encourage all qualified candidates to apply.

The job requires working within a cGMP manufacturing biotechnology facility with cleanroom operations and proper hygiene.