- The engineer/ scientist in manufacturing operations is responsible for execution of the manufacturing process in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug substance.
- Additional roles include using operational and technical knowledge to lead troubleshooting activities, lead tech transfer and start-up activities, provide investigations support, analyze process data, and identify and implement process improvements. Responsibilities Executes routine manufacturing activities including cell culture maintenance and harvests (e.g. bioreactors, continual flow centrifugation, ultrafilration and diafiltration) and equipment preparation (set-up, CIP, SIP).
- First-line technical support within their assigned Asset Group, collaborating with outside groups as needed.
- Process monitoring including real time review of process parameters and process data/trend analysis.
- Communicate process performance across shifts and departments. Implement process enhancements, measures and responds to equipment capability and implements new technologies. Support procurement and validation of new equipment and technologies.
- Support or champion compliance investigations, commitments, and change controls.
- Provide support during audits and with audit observation closure. Perform skills training and provide subject matter expertise to training materials.
- A/BS in chemical engineering, biology, biochemistry or other related science or engineering field 0-2 years relevant experience Familiarity and experience with cell culture, protein purification and/or support operations (such as solution preparation and/or operation of autoclave)
- Previous experience in a GMP manufacturing environment desirable
- Previous experience with manufacturing-continual flow centrifugation and/or tangential flow filtration (UF/DF) a plus
- Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus.
- Basic computer skills are required.
- Strong oral and written communications skills are desired. Mechanical aptitude is helpful.
Physical Requirements:
- Daily routine may require moving heavy equipment, standing for long periods of time, and/or significant walking throughout the suite including up and down stairs.
- Must be able to lift ~50 pounds. 1st shift, 6am -6pm, rotating
- Areas of Expertise Manufacturing Yes 1 - 2 Year.
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3348 | Fax: 973.998.2599
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