Job Details

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.

Essential Duties and Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• 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.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.

• 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:

Typically requires a Bachelor of Science degree or equivalent

Experience:

• 0–2 years of related experience