Fermentation Lead Technician

Position will coordinate the activities and technicians in Fermentation production and Support areas in the production of licensed products and intermediates. Generates schedules for production, formulation and fill and packaging of products. Candidate will perform all tasks for the fermentation and downstream processing of active biological antigens. Colleague will understand basic microbiological techniques associated with fermentation and downstream processing duties such as filtration and concentration. Utilize mechanical skills to maintain equipment and identify mechanical problems. Maintain a safe work environment as well as demonstrate reliability in attendance.

EDUCATION, EXPERIENCE AND TECHNICAL SKILLS:

• Bachelor of Science in Microbiology, Biology, Biochemistry, biochemical engineering, chemical engineering, industrial microbiology, or related degree
• Minimum of 5 years’ experience in a manufacturing environment
• Experience with the manufacture of biological products is required
• Experience in a USDA licensed facility required
• Prior experience with leading projects and mentoring technical staff
• Working knowledge of USDA regulatory requirements
• Must have demonstrated team leadership skills and be able to communicate effectively with people and team members at all levels of the organization
• Self-motivated with a strong work ethic
• Demonstrate reliability in attendance and punctuality
• Demonstrated knowledge of fermentation including basic microbiological techniques to prepare and maintain cultures, including inoculating, inactivating, harvesting and dispensing product as applicable to bacterial antigen production
• Knowledge of and ability to operate computer control systems
• Ability to give direction as needed with respect to machine operation
• Assists with diagnosing and trouble-shooting maintenance related issues.
• Will require some flexible hours, including occasional early mornings or evenings, as fermentation processes often do not follow rigid schedules.
• Performs Cleaning in Place (CIP) routines on all required process equipment
• Helps maintain and calibrates laboratory equipment.
• Helps maintain and calibrates process equipment.
• Comply with Standard Operating Procedures (SOPs) and associated documentation necessary to perform job functions
• Knowledge of proper PPE for handling microbial agents.
• Good math skills for calculating concentrations of solutions
• Knowledge of proper data capture, such as with Notebooks, or Process Worksheets
• Knowledge of equipment use such as autoclaves, microscopes, incubators, automatic pipettes, shakers, water baths, etc.
• Must be able to read, understand, and execute detailed written instructions
• Must be able to learn and follow site, equipment, and personnel trafficking policies
• Must be able to interact with and express requirements in a positive and professional way to colleagues at all levels within the organization

POSITION RESPONSIBILITIES:

• Leads fermentation production team in compliance and quality improvement efforts.
• Ensures adequate capacity by scheduling facility and equipment utilization and recommending changes and capital purchases.
• Analyze current production processes and identify potential improvements
• Must be a self-starter, motivated, and collaborative
• Ensures compliance with all trafficking and housekeeping requirements.
• Ensures compliance with respect to employees, laboratory, and documentation.
• Cleaning and replacement of glassware, solutions preparation, autoclaving and general lab organization
• Assist in general laboratory management including inventory, ordering, and organization
• Assists other laboratory/manufacturing personnel in high volume, multiple-task related activities
• Recording data promptly and accurately
• Implementing task lists as outlined by supervisor or other senior laboratory personnel
• Conducting work in accordance with appropriate company policies and regulatory agencies
• Conducting work in accordance with company safety requirements
• Monitoring of laboratory equipment
• Assists in developing procedures for internal and external customers, including protocol development, SOP development, and personnel training
• Maintaining accurate inventories of raw material, in-process material, and finished goods
• Routinely surveying facility, equipment, and systems, to ensure all areas are in excellent working conditions (organized, clean, safe)
• Assist in training entry-level employees