Senior Manufacturing Associate I/II - Downstream

KBI Biopharma • Durham, NC

10d • Onsite

About The Position

Job Summary: The Sr. Manufacturing Associate I/II is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. The Sr. Manufacturing Associate I/II must follow the instructions depicted in SR’s, EPR’s, BR’s, SOP’s and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time’ (RFT). Identify possible process and record improvements and communicate this to the appropriate personnel. The ideal candidate will be both technically sound and have a quality mindset. The candidate will use and demonstrate their past experiences and knowledge of cell culture Upstream or Downstream fundamentals in cell culture media preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, aseptic technique, chromatography, ultrafiltration, and drug substance filling operations; as well as in analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolarity meters) to teach, troubleshoot and continuously improve the daily operations of manufacturing. The Sr. Manufacturing Associate I/II will promote and enforce precise and compliant operations. The Sr. Manufacturing Associate I/II will maintain a sense of ownership of the production processes manufacturing environment and facility. Following task execution, the Sr. Manufacturing Associate I/II will review the executed production records (SR’s, ERP, and BR’s) to ensure a comprehensive and accurate set of actions have occurred. It is management’s expectation that any deviations/events are documented and escalated to the Management and Quality system according to KBI internal notification processes.

Requirements

• Sr. Manufacturing Associate I - Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ experience in related GMP manufacturing operations; or high school diploma with 7-10 years’ experience in related GMP manufacturing operations.
• Sr. Manufacturing Associate II - Bachelor’s degree in a related scientific or engineering discipline and 5+ years’ experience in related GMP manufacturing operations; or high school diploma with 10+ years’ experience in related GMP manufacturing operations.
• Knowledge, Skills, Abilities: Demonstrated knowledge of cell culture, fermentation or purification unit operation is preferred.
• Excellent written and verbal communication skills are required
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
• Language Ability: 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 customers or employees of organization.
• Reasoning Ability: 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.
• Math Ability: 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 and to draw and interpret graphs.
• Physical Demands Standing and sitting for long periods of time may be required at times. Lifting, pushing, and pulling may be required for stocking and movement of equipment. The use of ladder may be required when setting up bioreactors.
• Computer Skills Knowledge of and experience using MS Office, ERP, EDMS, production equipment software, other
• Equipment Use Knowledge of and experience using equipment - (Examples include Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling systems, Peristaltic Pumps and 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. )
• The job requires working 12-hour shifts which may include working overnight.
• The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene.

Nice To Haves

• Experience in single-use platform technology is preferred.

Responsibilities

• Manufacture cell culture products per manufacturing batch records and in compliance with quality standards, company policies and current regulations.
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
• Document each task involving manufacturing procedures (i.e. SR’s, EPR’s and BR’s) following GDP at the time of execution.
• Utilize and perform maintenance on equipment per applicable SOP.
• Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
• Demonstrate, apply and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks and responsibilities.
• Participate and be accountable for room 5S
• Provide direction/guidance to Manufacturing Associate I and Manufacturing Associate II, Senior Manufacturing Associate I and Senior Manufacturing Associate II.
• Help supervisor to distribute the workload and ensure others understand the requirements of their tasks

Benefits

• KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching, and employee recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees