Supervisor, MS&T

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:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance 
8. Life & Disability Insurance
9. 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 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, and small-scale fill/finish. 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 three distinct, but integrated, channels. The Manufacturing Process Execution team executes batch production records and SOPs in a cGMP environment, focusing on ‘right first time’ and on-time delivery. The Manufacturing Process Optimization team is responsible for implementation strategy and design of core processes and procedures carried out within the cGMP facility, representation of the manufacturing team during internal and external discussions, monitoring of process execution, campaign analysis, and maintenance of processes throughout a product lifecycle. The Manufacturing Process Compliance team provides support for cGMP Manufacturing operations, ensuring compliance with all applicable internal SOPs as well as regulatory and client requirements.

The Position

The Technical Services-Manufacturing Technology department supports new inspection, labelling, assembly, and packaging line implementation as well as ensuring technical stability and operational efficiency of current lines. The group provides technical leadership for packaging and is the client facing liaison for the site on inspection and packaging projects. Additionally, the team provides on-the-floor technical oversight of the manufacturing process, troubleshooting manufacturing issues by coordinating cross-functional solutions, and driving continuous improvement.  The group has oversight of in-house created labels, production batch records, and change management. The position is expected to follow detailed instructions and established procedures with minimal supervision.

Relationships

Reports to: Manager, MS&T

Direct Reports: 5-15

Essential Functions

• Project Delivery: The supervisor will ensure batch manufacturing readiness, support operations for rapid response and Person In Plant (PIP), and monitor department financial objectives.
• Operational improvements: The supervisor will continually optimize staff and department processes, drive a ‘right first time’ culture, and support various other site initiatives as assigned.

• Compliance: Ensures that deadlines are met and closely monitors the need for extensions to maintain compliance to site and industry standards.

• People Leader Functions:
• Develop and motivate people; including coaching and mentoring to reach department goals and enhance employee well-being, growth, and professional development.
• Be a visible and approachable leader who actively listens, sets a clear direction, and aligns team efforts with organizational goals.
• Drive the Organizational culture and role model effective and respectful communication.
• Encourage individual and team development to drive improvements

Qualifications

• 100% work scheduled based on-site at Bloomington, Indiana facility.
• Bachelor’s Degree required OR Master’s Degree preferred

• STEM degree preferred

• 1 year of GMP experience required of other regulated industry

• Experience in parenteral inspection and secondary packaging, preferred. 
• Technical Requirements:
  • Excellent written and verbal communication skills with internal and external customers
  • Ability to communicate complex technical information to non-technical audiences
  • Maintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines
  • Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution
  • Able to combine and interpret data from multiple disciplines and an understanding of the full Biologics process with respect to specific area of expertise
  • Begin to provide reliable and defendable interpretations of regulatory guidance for the customer
  • Well organized with ability to handle and direct multiple activities within the group simultaneously
  • Maintains staff by recruiting and hiring, employees, developing personnel growth opportunities, supporting employee motivation and providing strategic alignment with Quality Assurance Department and site initiatives

• Behavioral Requirements:
  • Positions views and arguments appropriately to win support
  • Convinces others to take action
  • Negotiates professionally in tough situations
  • Wins concessions without damaging relationships
  • Responds effectively to the reactions and positions of others
  • Understands internal and external stakeholder requirements, expectations, and needs
  • Balances the interests of multiple stakeholders within team
  • Acts fairly despite conflicting demands of stakeholders (client programs and team)
• Leadership Requirements:
  • Uses comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead projects within a department, group, or team in a single function or focus
  • Applies technical and functional knowledge to design projects that contribute to overall direction of department or discipline
  • Manages day to day activities with individual team
  • Focuses on and regularly communicates to team about team priorities and sets aside identified less critical tasks
  • Makes implementation plans and assignments that allocate resources appropriately to complete objective
  • Looks for obstacles and develops effective contingency plans with input for department initiatives and team's projects
  • Uses milestones to diligently track and manage the progress of the team and own work

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.