Job Description

Job Responsibilities:

• Produces development, pilot, and production materials without assistance.
• Assists with scheduling of weekly production/transfer/support activities.
• Independently capable of maintaining a BSL3 laboratory & performs lab audits.
• Assists in writing and executing protocols and reports for experimentation and qualification.
• Maintains laboratory equipment in a calibrated state.
• Initiates PDVs, NCEs and performs investigations & generates ERP reports.
• Originates moderate to complex ECO/SCOs with little assistance.
• Designs manufacturing processes to transfer to full production.
• Prepare technical reports for review by supervisor.
• Executes process validations of new and existing mfg. processes and general lab equipment.
• Performs troubleshooting & support activities on microbial/molecular issues.
• Trains others on new and existing mfg. processes, safety procedures and troubleshooting.
• Reports periodically to management on project progress and status.
• Represents dept as extended core team member.

Skills:

• 0-2 years of related experience
• Knowledge of Microbiology/Molecular and Chemistry.
• Working knowledge of laboratory safety and record keeping.
• Strong mathematics skills.
• Knowledge of ERP.
• Knowledge of GMP/GLP, ISO and CDC Safety Regulations Blood Borne Pathogen Training.
• Demonstrated job specific technical knowledge
• Demonstrated job specific BSL3 safety knowledge.
• Demonstrated ECO/SCO proficiency.
• Basic knowledge of technical writing.
• Basic presentation skills.

Education/Experience:

• Bachelor of Science degree or equivalent.  

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