Manufacturing Associate II (Nights)
On-siteDurham, North Carolina, United States
Durham, North Carolina, United StatesOn-siteFull TimeEntry LevelBachelors DegreeLarge
Full TimeEntry LevelBachelors DegreeLarge
Job Summary
Execute upstream or downstream production activities for Cell Culture programs within a GMP environment, including media/buffer preparation, seed expansion, bioreactor operations, and aseptic filling. Perform operations in a cleanroom while documenting all tasks in batch records and ensuring compliance with cGMP, GDP, and GLP standards. Maintain equipment per SOPs and participate in room 5S initiatives. Work a 12-hour rotating nightshift schedule (7PM-7AM) in a moderate-to-high noise environment.
Required Qualifications
- Bachelor's degree in a related scientific or engineering discipline
- 2-5 years' experience in related GMP manufacturing operations
- high school diploma with 4-6 years' experience in related GMP manufacturing operations
- Excellent written and verbal communication skills
- Energetic, motivated and dynamic individual
- Must be organized
- Ability to focus in a face-paced, multi-tasked environment
- Ability to maintain operational efficiency
- Positive demeanor
- Fluent in English language both reading and writing
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records
- Ability to write routine reports and correspondence
- Ability to speak effectively before groups of employees of organization
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
- Ability to compute rate, ratio, and percent
- Ability to draw and interpret graphs
- Standing and sitting for long periods of time
- Lifting, pushing, and pulling for stocking and movement of equipment
- Use of ladder when setting up bioreactors
- Use of mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards
- Moderate to high noise level tolerance
- Nightshift availability (7PM-7AM)
- 2-2-3 rotating schedule availability
- Clean room attire donning
- Good personal hygiene
- Gowning and cleaning procedures
- GMP compliance
- GDP compliance
- GLP compliance
- 'Right the First Time' (RFT)
- Sense of ownership of the production processes, manufacturing environment and facility
- Media/buffer preparation
- Shake flask operations
- Seed expansion
- Bioreactor setup and operations
- Cell culture harvest setup and operations
- Aseptic technique
- Chromatography
- Ultrafiltration
- Drug substance filling operations
- Analytical tools
- General biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolality meters)
- Review of executed production records (SR's, ERP, and BR's)
- GxP compliance
- Room 5S participation
- Accountability for room 5S
- Equipment maintenance per applicable SOP
- MS Office
- ERP
- EDMS
- Production equipment software
- Biosafety Cabinets
- Incubators
- Single Use Bioreactors
- Chromatography Columns/Skids
- Ultrafiltration Skids
- Filling systems
- Peristaltic Pumps
- Other Single Use pumps
- Automated Cell Counters
- Blood Gas Analyzers
- Metabolite Analyzers
- Scales and Balances
- pH and Osmolality meters
- Other lab, production, and office equipment
Desired Qualifications
- Basic knowledge of cell culture
- Basic knowledge of fermentation
- Basic knowledge of purification unit operations
- Experience in single-use platform technology
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