Chemist II

Overview

The Chemist II will be under the general supervision of Production Supervisor, working in a team based environment to support day to day EIA plate coating, EIA plate testing, Large Scale Buffer, hemolysate (blood products), Antigen purification and other manufacturing activities such as, but not limited to, EIA plate coating, Antigen blending, EIA and HPLC In-line testing, conjugation, Purification, and lyophilization.

The chemist is responsible for completing assigned process orders in a timely manner with supporting proper documentation. Additionally, the position also requires keeping the inventory transactions up to date to help manage the team with correct inventory.

• Education/
  
  Work Experience:
  
  BA/BS degree in Life Science or related discipline with 2-5 years of industry experience is required.
• Prior experience in large scale Bulk manufacturing, EIA plating and ELISA assay, centrifugation, Autoclaving, Sterilization and cartridge filtration.
• Experience in working in a regulated industry is a plus.
• Demonstrate proficiency in the use of basic laboratory techniques and equipment.
• Strong written and verbal communication skills.
• Able to work both independently and in a team environment.
• Good statistics and data analysis skill is desirable.
• Previous experience with ELISA assay, Protein Assays (DC or Bradford Assay) is desirable.
• Experienced with ERP systems (SAP or similar) for managing the inventory is preferred.
• Must be self motivated and results oriented.
• Proficient with MS Office.
• A basic working knowledge of working with high pressure equipment in a manufacturing environment.
• Basic math skills. Must be able to follow procedures and have good documentation skills.
• Use good manufacturing practices in a federally regulated environment.

• Perform manufacturing activities to meet scheduled time lines to support OTS (Off-the-Shelf) and Custom Products.
• Propose updates to documented manufacturing procedures and propose improvements. Conduct non-conformance root cause investigation.
• Assist Product Development and R&D during product transfer. Attend/provide input to MRB and QRB.
• Provide technical guidance and training to other production personnel.
• Work with laboratory equipment such as spectrophotometer, centrifuge, pH meter, EIA plate filling line and HPLC system.
• Prepare, analyze and conduct tests of large scale Buffer and hemolysate (Blood Products) according to specified procedures and schedule.
• Calculate constituents to be added to a product; review and record baseline and in-process results. Maintain good laboratory practices and documentation.
• Strive to maintain compliance in Customer Service Level, Quality, Cost and Continuous Improvement.
• Perform inventory transactions in a timely and accurate fashion.
• Write department SOPs, work instructions, deviation protocols, or out of tolerance reports as necessary.
• Help to support NPD (New Product Development) builds.
• Assist the supervisor with continuous improvement projects.
• Support the team with presenting solutions for better efficiencies in manufacturing practices.
• Manufacture products in accordance with approved written procedures and policies. Analyze, comply, input and present technical data as required. Maintain good laboratory practices and documentation.
• Ensure all required pre-production duties are performed prior to the start of process (procedures, equipment, raw material inventory, etc.).
• Monitor manufacturing process, performing adjustments when required.
• Review and complete batch record.
• Perform daily housekeeping and other related duties as required.
• Perform updates to approved procedures and propose improvements.
• Perform instrument maintenance and calibration as necessary (e.g., Centrifuge, Lyophilizer, pH meter, Spectrophotometer).
• Standing for up to 6 hours per shift in cold room.
• May handle heavy equipment and lift and/or move raw materials weighing up to 50 pounds. Also, work in the cold room for longer periods (1-3 hrs).

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