Operator II, Drug Substance - Downstream

Novo Nordisk A/S; Bloomington (IN); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health Insurance

14 holidays per year

401K with company match

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk is hiring for an Operator II in Drug Substance - Downstream at our Bloomington, Indiana site. The role executes upstream/downstream manufacturing steps with adherence to GMP, quality, and safety standards, performing process steps and monitoring equipment on a night shift (6PM–6:30AM) in a cleanroom environment.

Ideal candidates have a Bachelor’s degree in a related field and demonstrate basic GMP knowledge, documentation discipline, and ability to work independently within a cGMP

Education

Bachelor's Degree in related field

Job description

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Operator II, Drug Substance - Downstream

Facility: Manufacturing

Location: Bloomington, IN, US

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

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)

Relationships

Reports to Manager or above.

Essential Functions

• Preparation
  • Must pass eye exam for all positions within DS
  • This position is a mid-level position in the Preparation 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 integrity testing, washing, sterilization, and preparation of GMP equipment (stainless steel clamps, J-tubes, scissors, gas filters, valves, etc). using a parts washer, decontamination and sterilization autoclaves, pre- and post-use filter integrity testers, and several other common hand tools (Crimpers, Pliers, tubing cutters, etc.)
  • Follows detailed Batch Records and procedures to prepare and test drug substance equipment and consumables
  • Practices aseptic behaviour within in a clean room environment
  • Safely and accurately loads and operates large machines such as parts washers and autoclaves per procedure
  • Proficient at all GMP activities pertinent to respective area of discipline
  • 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
  • Operate 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
  • Executes other duties as assigned
  • 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
• This position is a mid-level position in the Sanitization 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 performing scheduled and unscheduled cleanings of the Drug Substance clean rooms, formulation of the approved sanitizing solution, as well as the restock of consumables and gowning materials
• 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
• Capable of leading basic area-specific processing tasks and drives tactical preparations
• Performs daily review of executed cGMP documentation (e.g. batch production records, forms)
• Performs consumable and gowning stocking and staging of production suites
• Formulation
  • This position is a mid-level position in the Formulation 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 formulation of GMP solutions (liquid medias/feed, buffers, sanitizing solutions) using Raw Materials that are consumed/used throughout the upstream and downstream processes. This is achieved using a variety of equipment and processes including general analytical equipment (pH meter, Conductivity meter, Osmometer), Single Use Mixers (SUMs), liquid handling equipment, Biosafety Cabinet, aseptic technique, scales, balances, various types of pumps, tube fusers, and tube sealers
  • 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
• Upstream
  • This position is a mid-level position in the Upstream 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 manufacturing of biopharmaceutical products via production of genetically modified mammalian cells. This is achieved using a variety of equipment and processes including general analytical equipment, liquid handling equipment, cellular diagnostic machinery (ViCell, NOVA Bioprofile), Biosafety Cabinet, aseptic technique, various types of pumps, tube fusers, and tube sealers
  • 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
  • Use of basic biomanufacturing equipment such as tube fusers, tube sealers, pumps, scales and balances
  • Clean and Sterilize applicable processing equipment (CIP/SIP)
  • Safely operates equipment within area
• Downstream
  • 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
  • Follows detailed procedures to purify, concentrate, and bulk fill drug substance
  • 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
  • Follow all safety and environmental requirements in the performance of duties
  • Other duties as assigned

Physical Requirements

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.

Qualifications

• 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

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.