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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