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 Manufacturing Sciences and Technology (MS&T) department’s primary function is to serve as an agile technical team to support process & technology transfer (e.g., mAbs, fusion proteins, new modalities, etc.), raw materials and consumables, technical writing, and drug substance lifecycle management. The MS&T organization supports the Drug Substance area of the Bloomington facility as well as the Catalent Biologic’s network through client-facing support, on-the-floor or on-call technical coverage, and continuous improvement.

  The team is the technical liaison between Process Development (internal or external) and at-scale GMP manufacturing. This function includes drafting and supporting required batch documentation (i.e., gap assessments, reports, batch records, product impact), as well as process modeling and facility fit including initial bill-of-material development. Once production starts, the team provides on-the-floor-support to assist Manufacturing as questions are raised and to look for opportunities where the process could be improved.

  The MS&T team provides technical support of late-phase work. The group works with a cross-functional team (including Process Development and Validation) as the program progresses through commercialization.

  The Position

  This role will be responsible for the technical transfer of processes from Process Development or our clients. It will also involve drafting and review of documentation, compilation, and assessment of process data, and providing technical input for deviation investigations, change controls, and CAPAs. This role will provide on-call and on-the-floor technical support to manufacturing. This position will be client facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

  Relationships

  Reports to: Manager, MS&T

  Essential Functions

• Perform as a subject matter expert (SME) for a Drug Substance operation (e.g., production bioreactor processes, chromatography, tangential flow filtration, etc.)

• Utilize Process Development and client provided process data to review proposed GMP scale process descriptions. Create process flow diagrams from process descriptions

• Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements

• Review daily processing data from GMP manufacturing to monitor process performance

• Authors and approves technical documents, such as batch records, protocols, bills of materials, sample plans, manufacturing campaign reports, operating procedures, etc.

• Review technical and validation documents for accuracy and thoroughness

• Perform assessments on material changes as disclosed by suppliers

• Participate in client meetings offering technical support

• Work cross functionally with Process Development, Manufacturing, Engineering, Automation, Quality Assurance, Quality Control, Supply Chain, Project Management, Validation, Facilities, and other departments to effectively transfer and maintain processes in the facility

• Work closely with manufacturing to author appropriate batch documentation and provide technical oversight associated with GMP manufacturing

• Support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations

• Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency, and competitiveness within the market

• Support the building of business case(s) for process improvement projects

• Act as the lead for deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification

• Perform other responsibilities to support group, site, and network-based initiatives, as required

  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 10 pounds and occasional lifting and/or moving up to 50 pounds. Must be able to work in a cleanroom environment, including being able to don cleanroom gowning, for up to 4 hours continuously. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.

  Qualifications

• Bachelor's degree in Science and 1+ years of experience Required.

• Technical Requirements:

• Maintain high quality technical documentation in accordance with applicable regulatory guidance and site SOPs

• Ability to learn and retain technical information

• Proactively address work issues at both an individual level and a team level

• Develop and execute procedures or protocols with high quality, with guidance

• Ability to follow and interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Proactively seek information to fill gaps in knowledge base

• Mathematical and scientific reasoning ability. Able to compile data and provide limited interpretation of data

• Ability to identify aberrant/out of spec data and interpretation of data expected. Propose deviations and method improvements based on sound scientific judgement

• Well organized with ability to handle and direct multiple activities simultaneously

• Ability to use Microsoft Office® (e.g., Excel, Word, Project, Visio) programs, and ability to learn software associated with various manufacturing systems

• Ability to interpret data, analyze trends, and provide insight into potential issues and subsequent solutions, with guidance

• Ability to problem solve to initiate, execute, and monitor corrective action

• Ability to write SOPs, batch records, and reports with guidance

• Ability to work with and lead other groups to perform investigations (including deviations), and change controls, and to drive these activities to completion

• Ability to acquire technical knowledge through on-the-floor exposure to biological manufacturing

• Ability to learn validation concepts and follow procedures in a GMP environment

• Ability to provide ideas, introduce new technology, and drive process improvements

• Strong interpersonal and presentation skills to discuss technical concepts internally and with clients

• Ability to learn and use software packages (e.g., TrackWise®, ComplianceWire®, PI Vision®)

• Ability to learn Tech Transfer between Development and Manufacturing

• Ability to operate within a clean room environment

• Ability to learn the application of Root Cause Analysis tools (e.g., 5 Whys, Fishbone, Is/Is Not, etc.)

• Communication Requirements

• Excellent written and verbal communications skills with internal and external customers

• Ability to communicate basic technical information to non-technical audiences

• Ability to read, write, and speak clearly in English

• Leadership Requirements:

• Lead by example and follow Catalent's values, mission, and appropriate level of leadership competencies at all times

• Behavioral Requirements:

• Ability to see and hear

• Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing

• 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, in a professional and accurate manner

• 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 with ability to work effectively under high pressure with multiple deadlines

• Strong ability to multi-task in a fast-paced environment

• Positive attitude and ability to work with others

• Ability to process a large volume of work

• Ability to effectively carry out and implement change

• Ability to put aside personal opinions and focus on business needs, department needs, or group needs

• Willingness and ability to work outside of standard work hours, including some weekends

  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.