- Operator in the production of adjuvant via prep scale RP-HPLC, solvent exchange, lyophilization and product vialing using equipment such as analytic HPLC systems, lyophilizer, processing vessels, RP-HPLC prep scale chromatography columns, etc.
- Perform in-process (adjuvant) analytical techniques. Includes some solution formulation, column packing, lab ware preparation.
- Perform weekly checklist, monthly cleanings, inventory of raw materials and supplies, requisitioning, receipt, log in and storage of materials and supplies as required.
- Troubleshoot equipment, computer and process problems.
- Maintain production areas in a clean, organized, and safe manner. Maintain organized and updated written records and complete GMP documents accurately.
- Write, revise and implement Manufacturing Control Procedures and Standard Operating Procedures.
- Comply with Standard Operating Procedures, Manufacturing Control Procedures, cGMP’s, safety policies and company policies.
- Originate or revise MCP’s and equipment SOP’s, related material QCS’s as required.
- Assist in writing and execution of validation protocols. Maintain trend data. Additional duties may be added as required, at the discretion of the Manufacturing Manager or Plant Manager.
- Experience in Prep Scale RP- HPLC manufacturing (use of Agilent Systems ideal).
- Must have strong communication and organizational skills. Must read, write, speak and comprehend English. Must follow written and verbal instructions.
- All employees are required to arrive promptly for their assigned shift and minimize absences.
- Must be able to stand, walk, lift, and perform repetitive tasks for extended periods of time. Strong mechanical aptitude a plus.
- Must be able to use computers competently to run manufacturing process and should be able to use typical applications such as spreadsheets and graphing efficiently.
- Must work independently with minimal supervision on assignments within the scope of training. Must be able to exercise judgment and make decisions (within accepted guidelines) based on data analysis. Must be able to exercise judgment in recognizing and resolving deviations.
- Should be able to make recommendations for solving problems and improving operations.
- Must be able to organize and prioritize daily tasks.
Education and Experience:
- BA/BS in a scientific discipline with 2-4 years’ experience in a closely related manufacturing or laboratory environment. A relevant Certificate or Associates degree with strong experience will be considered as well.
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