Operator II, Drug Substance - Downstream

Novo Nordisk•Bloomington, IN

7d•Onsite

About The Position

Executes drug substance manufacturing operations with a high degree of independence, performing process steps, monitoring equipment, and troubleshooting routine issues in compliance with GMP, safety and quality requirements, to ensure reliable and consistent production of high-quality product. This role works nights; 6PM - 6:30AM (rotating 3,2,2). This position is a mid-level position in the Downstream Manufacturing team and is the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Manufacturing Operator is responsible for the purification of biopharmaceutical products via a variety of different physical and chemical purification techniques including size exclusion filtration, Centrifugation, Tangential Flow Filtration (TFF), Viral Inactivation and Filtration, Column Chromatography. These purification techniques are further supported utilizing a variety of equipment and processes including general analytical equipment (pH and conductivity meters), liquid handling equipment, Single Use Mixers (SUMS), Stainless-Steel Tanks, diagnostic machinery, Biosafety Cabinet, aseptic technique, various types of pumps, tube fusers, and tube sealers.

Requirements

Must pass eye exam for all positions within DS
Ability to read and write English
Perform basic math skills (+, -, x, /, %, understand decimals)
Required to read, understand, and follow GMP documents
Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry)
Works independently on limited scope issues
Bachelor's Degree in related field of study from an accredited university required and a minimum of zero (0) year of relevant experience required
In lieu of Bachelor's Degree with zero (0) year of experience, may consider an Associate's Degree in related field of study from an accredited college or university with a minimum of zero (0) year of relevant experience required
In lieu of Bachelor's Degree with zero (0) year of experience, may consider a High School Diploma or equivalent with a minimum of one (1) year of relevant experience required

Nice To Haves

Capable of leading basic area-specific processing tasks and drives tactical preparations and batch closure tasks
Provides basic on-call support for alarm management, as necessary
Trains junior team members in basic biomanufacturing processing activities
Raises atypical observations and notifies management/quality as required
Completes routine and basic preventative maintenance of equipment
Performs equipment/room cleanings as required
Identifies and raise opportunities for procedural improvements.
Supports continuous improvement initiatives
Operates in a clean room environment within required gowning, aseptic behaviours, and proper flow procedures
Performs general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards
Assists in stocking and staging production suites
Addresses corrections to all executed documentation in a timely manner to support lot release
Works scheduled shift and other off-shift coverage as required
Follows procedures and schedules in accordance with the site’s Environmental Monitoring strategy to ensure compliance regarding cleanliness of Drug Substance clean rooms
Safely and effectively mops cleanroom, floors, walls, and ceilings
Formulate sanitizing solutions using detailed procedures, floor scales, and conicals
Performs daily review of executed cGMP documentation (e.g. batch production records, forms)
Performs consumable and gowning stocking and staging of production suites
Follows detailed Batch Record and procedures to formulate drug substance
Performs aseptic techniques within in a clean room environment
Safely operates Single Use Mix tanks to support large-scale formulations, as well as required equipment for small scale batches (<50L)
Uses basic biomanufacturing equipment such as tube fusers, tube sealers, pumps, balances, pH meters, stir-bars, and other applicable manufacturing equipment
Performs small- and large-scale cell culture work in a clean room environment under direct supervision, including, but not limited to: Manipulation of cell culture in shake flasks Single-use bioreactors (SUBs) Cell culture analysis using automated cell counters, bioanalyzers, sample preparation, osmometers, and any other applicable laboratory instrumentation
Clean and Sterilize applicable processing equipment (CIP/SIP)
Safely operates equipment within area

Responsibilities

Executes drug substance manufacturing operations with a high degree of independence, performing process steps, monitoring equipment, and troubleshooting routine issues in compliance with GMP, safety and quality requirements, to ensure reliable and consistent production of high-quality product.
Purifies biopharmaceutical products via a variety of different physical and chemical purification techniques including size exclusion filtration, Centrifugation, Tangential Flow Filtration (TFF), Viral Inactivation and Filtration, Column Chromatography.
Operates biomanufacturing processing skids, including but not limited to, chromatography and normal flow filtration.
Uses basic biomanufacturing equipment such as tube fusers, tube sealers, pumps, balances, pH meters, conductivity meters, mix tanks and other applicable manufacturing equipment.
Performs packing and unpacking of large-scale chromatography columns.
Performs final storage freezing of product as required.
Follows all safety and environmental requirements in the performance of duties.
Other duties as assigned.