Job Description
Job Summary:
- Responsible for the manufacture of bulk clinical and commercial kit reagents and for sub-assembly formulation, raw material prep and/or processing.
- Actively participate in transfer and support activities and continuous improvement on the existing processes.
- May be assigned to one or more functional areas in Operations.
Duties and 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.
- Prepares 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.
Education:
- Typically requires a Bachelor of Science degree or equivalent.
Experience:
- 0-2 years of related experience.
Knowledge, Skills and Abilities:
- 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.
Physical Demands:
- Sit; use hands to finger, handle or feel objects, tools, or controls.
- Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
- Lifting/pushing/pulling and carrying products weighing up to 45 pounds
- Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels.
- Potential Exposure to hazardous chemicals or other materials.