Clinical Manufacturing Scientist Job

CLINICAL MANUFACTURING SCIENTIST needed for a CONTRACT opportunity with Yoh's client located in PRINCETON, NJ.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Cell Culture
- Purification
- cGMP

WHAT YOU'LL BE DOING:

- Performance of cGMP Operations in accordance with Standard Operating Procedures (SOP's); Master Batch Records (MBR's); Equipment Qualification Protocols; and other applicable instructional documentation. Inclusive of: Shipping, Receiving, Raw Material Release and Inventory Management. Weigh, Dispense and Solution Preparation. Upstream and Downstream Manufacturing Operations
- Communicates status of operations, process issues, and safety & maintenance issues to Area Management immediately.
- Provides initial review of executed documentation for completeness and accuracy.
- Creation and revision of cGMP documentation, including but not limited to MBR's, SOP's, etc. under QRM (Quality Risk Management) philosophies.
- Assist in lab experiments and document results in either paper or electronic lab notebook system.
- Prepare analytical reagents, media and solutions required for process development.
- Handle assembly and disassembly of laboratory equipment using glass washer, sonic sink, and autoclave.
- Glassware wash and sterilization.
- Participate in starting up facility and process equipment.
- Innovate technologies that embrace QRM, continuous improvement, reduce manufacturing costs and increase manufacturing efficiency
- Ensures that all production equipment is functioning properly and production processes meet documented quality standards.

WHAT YOU NEED TO BRING TO THE TABLE:

- BS in Engineering or equivalent life sciences degree
- Minimum of zero to six (0-6) years of experience
- Cell culture and purification experience
- Excellent communication skills that facilitate operations in cross functioning groups
- Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks
- Must have the ability to stand for long periods of time
- Works in production environment with exposure to latex

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Knowledge and/or demonstrated ability in cGMP bioprocess operations of mammalian expressed glycoproteins or mAbs is preferred.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC

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