Operator II, Drug Substance
Novo Nordisk
This job is no longer accepting applications
See open jobs at Novo Nordisk.See open jobs similar to "Operator II, Drug Substance" Indiana Uplands.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
This position works approximately two weekends a month, and this is a night position.
Two days on (Monday, Tuesday), two days off (Wednesday, Thursday), three days on (Friday, Saturday, Sunday) (week 1)
Two days off (Monday, Tuesday), two days on (Wednesday, Thursday), three days off (Friday, Saturday, Sunday) (week 2)
Relationships
Reports to Manufacturing Supervisor.
Essential Functions
- Sanitization
- 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
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
- High School/GED required
- Associate degree preferred
- 1 year relevant experience required
- 2 years GMP experience preferred
- Technical Requirements:
- Proficient with Microsoft Office programs, Email, Teams, etc.
- Ability to learn and use quality, operations and/or scientific management software such as ComplianceWire®, JD Edwards®, MES®, etc.
- Ability to understand and apply cGMPs to everyday work
- Demonstrates basic understanding of the work tasks assigned
- Executes procedures with high quality and attention to detail
- Basic understanding of pharmaceutical laboratory and/or production operations
- Capable of learning unfamiliar principles or techniques with training
- Behavioral Requirements:
- Ability to see/hear and read/write clear English
- Lead by example according to the Company's values and culture
- Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary
- Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
- Ability to cooperate with coworkers within an organized team environment or work alone
- Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines
- Ability to put aside personal opinions and focus on business needs, department needs or group needs
- Leadership Requirements (if applicable):
- Leads by example according to the Company's values and culture
- Builds on contacts and relationships with peers
- Takes initiative for personal and professional development
- Takes initiative when necessary to address changes in scope and procedural errors
- Builds trust and respect for self and department
- Expected to fulfill and maintain designated trainer requirements as needed
- Promotes compliance by providing respectful & constructive peer-to-peer feedback
- Capable of leading basic area-specific processing tasks
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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.
This job is no longer accepting applications
See open jobs at Novo Nordisk.See open jobs similar to "Operator II, Drug Substance" Indiana Uplands.