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.
What does a typical day look like?
Working on process orders (lab work). Lab maintenance. General material orders.
Preferred background/prior work experience? Experience in microbiology lab or B.S. in Biology or related science field.
Priority soft skills-Time management, effective communication, task prioritization, attention to detail
Physical Demands:
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- ☒ 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
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
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