What are the responsibilities and job description for the Operator I, DS CLT position at Novo Nordisk?

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 life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, 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 Drug Substance - Operations department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master / working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

The department is comprised of four distinct, but integrated, units. The Formulation / Support team executes GMP formulations of various growth production medias and feeds to support the upstream process, as well as a variety of different buffers and sanitization solutions to support the downstream purification process. The Formulation Department utilizes Master Batch Records and SOPs in a cGMP environment, focusing on ‘right first time’ and on-time delivery for each formulation. There are two other teams that provide further support to the Upstream / Downstream areas known as the Preparation (Prep.) and Sanitization teams. These are relatively small teams (3-4 per shift) but are vital to the sustainability and efficiency of the process. The Prep. team is responsible for a variety of GMP activities that prepare / build rotating assets, stainless steel parts, and processing assemblies for future use in an upcoming process, test already-used parts to ensure their integrity was maintained during use, and handling / exchange of liquid and gaseous Nitrogen Tanks. This is accomplished using a variety of equipment including 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.) The Sanitization crew is also responsible for a variety of tasks but is mainly focused on the sanitization of the Drug Substance Clean rooms. They follow a strict schedule of daily, weekly, and monthly sanitizations using three main cleaning solutions : Sporklenz, LPHSE, and Vesphene. The sanitization of the block is critical to ensuring the cleanrooms meet FDA guidelines regarding acceptable levels of bioburden and particulates on hard surfaces and in the air for pharmaceutical production. The sanitizations are executed using clean room approved mops, as well as non-particulating wipes in conjunction with the approved sanitizing solutions. The Sani. Crew is also responsible for the restock of common-use consumable items inside the block, as well as gowning materials in the entrance airlocks to the GMP suites.

The Upstream team executes a variety of GMP processes focused on scale up and production of genetically modified mammalian cell culture in various sizes of shake flasks utilizing aseptic technique, Single Use Bioreactors, and Stainless-Steel Bioreactors. The fundamental goal of the upstream process is providing the proper environment to support cellular growth, and protein production. The cells have been genetically modified to produce a specific protein (the drug itself) - the protein of interest (POI) or Active Pharmaceutical Ingredient (API). The Upstream team utilizes batch records and SOPs in a cGMP environment, focusing on ‘right first time’ and on-time delivery for each step of the process.

The Downstream team is responsible for purification of the Protein of Interest out of the cell culture created by the Upstream team. They accomplish this using a variety of different purification techniques including size exclusion filtration, Tangential Flow Filtration (TFF), Viral Inactivation and Filtration, Chromatography, and Bulk Fill. Once >

99% purity of API has been achieved, the Bulk Drug Substance (BDS) is Bulk Filled, and subsequently frozen for stability purposes. The Downstream team utilizes batch records and SOPs in a cGMP environment, focusing on ‘right first time’ and on-time delivery for each step of the process.

The Indirect Operations Team supports the other three areas in a variety of ways including, but not limited to creation of schedules, batch record review, data analytics, statistical analysis, deviation investigations, deviation tracking, audits, CAPA’s, and document review.

The Position

This position is an entry 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.)

Relationships

Reports to : Manufacturing Supervisor

Work Location : Onsite in Bloomington

Essential Functions

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

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

Formulation :

This position is an entry 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 (

Uses basic biomanufacturing equipment such as tube fusers, tube sealers, pumps, balances, pH meters, stir-bars, and other applicable manufacturing equipment

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 behaviors, 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

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

Education / Experience :

High School / GED required

0-2 years relevant experience

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

Behavioural Requirements :

Ability to see / hear and read / write clear English

Lead by example according to Catalent'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) :

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

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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.

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