3439 Manufacturing Technical Specialist II
In this position, you will need to work effectively as part of a team responsible for ensuring successful and efficient pilot plant upstream/downstream operations and support of the site launching capability for the production of marketed recombinant proteins and their respective tech transfers.
The group conducts hands-on small scale and pilot plant operations with studies to continuously improve and optimize process performance, troubleshooting of our commercial scale make-assess-release, and supporting site tech transfers.
This individual must have the ability to adapt to rapidly changing priorities and has the flexibility to support small scale and pilot plant operations in accordance with the manufacturing and pilot plant schedule.
Responsibilities will include:
Perform routine small scale and pilot plant operations, including small scale and pilot scale media/buffers preparation, 20L bioreactor, 100L single-use bioreactor (SUB), 400L bioreactor, centrifuge, depth filtration system, and 500L SUB harvest hands-on operation, chromatography operations at small and pilot scale (AKTA), and UFDF operations at our pilot scale.
Support and perform cell perfusion operations Clean-in-place (CIP) and steam-in-place (SIP) operations and perform any troubleshooting of the small and pilot plant equipment.
Support daily sampling, continuous trends and data monitoring, and assist in data analysis of small scale and pilot plant upstream and downstream data.
Monitoring and analysis of manufacturing data as necessary.
Data design and execution of experiments aimed at improving process robustness/productivity
or meeting the changing needs of the manufacturing environment.
Developing and implementing technologies that enhance our manufacturing operations. As with
any position in a manufacturing environment, the job requires an ability to adapt to rapidly
changing priorities and the flexibility to support operations in accordance with the
Previous hands-on work experience in small scale laboratory and Pilot Plant upstream/downstream
operations is highly desirable.
Proficiency in data analysis techniques, MS Office (i.e. Word, Excel, and Powerpoint), JMP statistical software tool, and basic laboratory skills, including aseptic technique is desirable.
Candidate should be highly motivated, be able to work independently, as well as in a team, and have good organizational skills.
Understands basic manufacturing, engineering and/or scientific theories, principles and techniques used in biopharmaceutical manufacturing processes and pilot plant operations.
BS or higher degree required, in engineering and science related field (chemical engineering,
biochemical engineering, molecular biology, biochemistry).
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.