General Description:

The Cell Culture Manufacturing Senior Technician position will directly enable the initial start-up phase of the Hopewell manufacturing facility and then shift focus to hands-on execution and support of cGMP manufacturing operations.

1. Hands-On cGMP Operations: Focused on execution of cGMP manufacturing activities required to deliver the production plan reliably and compliantly. Essential functions of the job include but not limited to:

a. Follow cGMP procedures to support manufacturing execution and automated recipes

b. Clean-In-Place (CIP) & Steam-In-Place (SIP)

c. Media preparation & transfers / filtration

d. Cell culture sampling, monitoring & transferring

e. Harvest operations

f. Equipment & process troubleshooting

g. Deviation identification, reporting and closure

h. cGMP procedure development and optimization

i. Cleaning and garbage discharge

j. 6S operation

k. Equipment validation (bioreactor IOQ and PQ study, but not limited to the other cell culture validation activity).

Experience Required

· At least 3-5 years working in cell culture area in Biopharm industry.

· Familiar with single use bioreactor, such as Wave bioreactor, Sartorius or Cytiva bioreactor 200-2000L

· Familiar with inoculation aseptic technique

· Familiar with stainless steel vessel operation with DCS control (Medium Preparation, CIP/SIP)

· Familiar with Part washer or autoclave operation

Additional Skills/Attributes Required:

· Evidence of good verbal and written communication.

· Ability to work in fast paced dynamic environment with competing priorities.

· Demonstrated ability to collaborate within and between diverse groups.

· Proactive identification and implementation of continuous improvement opportunities.

· Able to receive and incorporate feedback – passion for ongoing professional development a plus.

· Aptitude for learning moderately complex technical systems.

Physical Requirements:

· Must be able to stand for long periods, up to 8 to 10 hours/day.

· Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.

· Must be able to work scheduled 40 hours with the ability to work overtime as needed.

· Must be comfortable in working in varying temperatures. · Frequent lifting, pushing, pulling, and carrying. Ability to lift to 40 lbs. · Regular reaching, bending, stooping, and twisting. · Repetitive motion and substantial movement of the wrists, hands, and/or fingers. · Environment requires dedicated gowns, depending on area. · Work with hazardous materials and chemicals. · Willing to work any shift.

Posted On: Thursday, December 12, 2024